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03 - Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the NBMC - Correspondence
Received After Agenda Printed March 12, 2024 Agenda Item No. 3 Joe Cartwright Chief of Police Newport Beach Police Department 870 Santa Barbara Dr. Newport Beach CA 92660 Dear Chief Cartwright, I appreciate you and taking the time to read this letter. We appreciate the Police Department and everything you do to keep our city safe. We always feel safe as business and have appreciated your commitment to maintain the quality of that is cherished by those who reside, work, and visit Newport Beach. I am told that this will be on the agenda for the next Newport Beach City Council meeting on Tuesday, March 12. 1 realize you may have heard some compelling reasons to ban kratom. However, given the sudden announcement, will you consider delaying this motion for a future City Council meeting until after you hear counter arguments to a ban? I am an owner of the local business, Up in Smoke, which has served the community since 2015. 1 employ more than 7 employees who contribute to the tax base. As a person deeply involved in the world of Kratom, I think it is important to understand Kratom is not a drug. Kratom is not a synthetic substance. Kratom contains no opiates but it does bind to the same receptor sites in the brain. Chocolate, coffee, exercise and even human breast milk hit these receptor sites in a similar fashion. Naturally occurring Kratom is a safe herbal supplement. I have seen its transformative power. I've witnessed people find solace, relief, and renewed energy through this remarkable supplement. It's not just a botanical product; it's a lifeline for many. It has helped countless individuals manage pain, anxiety, and other health conditions. In fact, according to a study reported in Pain News Network, kratom was found effective for pain relief, helps users reduce their use of opioids and has a low risk of adverse effects, according to researchers at Johns Hopkins University School of Medicine. If you can spare a few minutes, I can describe why the proposed ban on Kratom by Newport Beach City Council will severely hinder my business and could potentially do more harm than good to our community. It is proven that prohibition on natural remedies such as Kratom, can lead to unintended consequences, such as pushing individuals towards more dangerous substances and fueling the black market. There are residents of Newport Beach, ranging from senior citizens, people in chronic pain to military veterans that use Kratom to manage their pain and navigate through their lives. More importantly, I can also describe why a ban will hinder potential health benefits that many residents could reap from this natural supplement. There is new information by the FDA that reveals the benefits of Kratom, signaling an outlook that endorses regulation over ban. I am a proponent of regulation and safe consumption, but to ban a natural plant outright seems counterproductive to the Harm Reduction policies of Newport Beach. I believe a better alternative is research and regulation. Currently there is a canon of research proving the relative safety of kratom. Instead of banning it outrightly let us champion education about it and implement responsible regulation. I believe by working together we can inform consumers about kratom and empower our people to make informed choices about their health and well-being. I am happy to come to you at a location that is convenient for you. If you have time to schedule a quick meeting, I would love to have a conversation about Kratom and its invaluable usefulness for people within our community. Faris Khouri Owner/Partner Up in Smoke m. 714-317-2557 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 11 March 2024 Joseph L. Cartwright Chief of Police City of Newport Beach Via email Re: Reconsidering Kratom in light of Forthcoming State and National Regulations Dear Chief Cartwright, I am Executive Director of the Global Kratom Coalition, an alliance of kratom consumers, experts, and industry leaders committed to protecting and expanding access to kratom across the globe. The GKC dedicates resources to advance scientific research and encourage education backed by science in order to protect consumers. The GKC also advocates for regulations designed to ensure that consumers have access to kratom products that are safe. I am writing to share information about regulations currently being considered on the state and national level that may influence your recommendation to ban kratom products in Newport Beach. My hope is the forthcoming regulatory actions will encourage you to delay your proposal. Currently there are several avenues lawmakers are considering that would create a regulatory framework for kratom producers. This legislation would include mandated labeling requirements, such as comprehensive ingredient lists, amount of alkaloids per dose, directions for use, recommended serving sizes and amount of servings per day, appropriate cautionary statements, and implementation of proper manufacturing processes. These regulatory principles create a framework for soon -to -be -adopted regulations that would help ensure a viable industry that can help consumers make informed decisions. In California and other states, lawmakers are currently considering legislation that would regulate kratom and offer the industry guidelines. Kratom Consumer Protection Act (KCPA) is model legislation that generally aims to set age restrictions for purchasing kratom, prohibit the adulteration of kratom products, mandate proper product registration and establish packaging and labeling standards. According to the American Kratom Association (AKA), 11 states have passed some version of the law. Lawmakers in Sacramento are working on legislation that will apply rigorous labeling and other restrictions to kratom products statewide. I can share more details on the plans to introduce this legislation in the current legislative session. Legislators on the federal level are also taking action on kratom. With bipartisan support, U.S. Senators Mike Lee, R-Utah, and Cory Booker, D-New Jersey, and Reps. Mark Pocan, D- Wisconsin, and Jack Bergman, R-Michigan, introduced the Federal Kratom Consumer Protection Act (S 3039 and HR 5905) in October. The proposed legislation aims to establish nationwide regulations for kratom products, mandating the Food and Drug Administration conduct comprehensive assessments of the health and safety of kratom. Additionally, the legislation would prevent the FDA from imposing arbitrary regulations on kratom products that exceed the restrictions placed on food or dietary supplements. The FDA, for its part, has also recently committed to aim to use science and facts to drive policy recommendations which will impact kratom regulations. According to food and beverage market trade Food Navigator, the FDA will "pursue access to accurate information that is easy to understand and transparency into how FDA evaluates food safety." The February 2024 article also quoted Kimberlee Trzeciak, FDA Commissioner for Policy, Legislation and International Affairs: "FDA are doing as much as we can to be more transparent and to provide sufficient assurance that the decisions we are making are science -based." The scientific community is also coalescing around FDA recommendations. As noted at the recent 3rd Kratom Symposium, the nation's leading scientists from well-known universities including Johns Hopkins and University of Florida are strongly encouraging further research on the various forms of kratom to help firmly establish, clarify, or dispel inaccuracies. The FDA's recent leaf kratom Single Ascending Dose (SAD) study and upcoming Human Abuse Potential (HAP) are critical components of the clinical research needed in this space. Initial research from these projects will be released later this year. The GKC believes by conducting robust research, regulators can contribute to a more evidence - based understanding of the various forms of kratom's risks and benefits. Regulations, backed by clinical data, will facilitate informed policymaking and regulatory oversight, which we believe will benefit kratom consumers across the country. As mentioned above, it is my desire that you will consider delaying your recommendation on a ban for products containing kratom. I would welcome the opportunity to discuss these policy matters with you at your earliest convenience. Thank you, Matthew Lowe Executive Director Global Kratom Coalition mlowe@alobalkratomcoalition.org GLOBAL KRATOM C O A L I T I O N 2024 Global Kratom Coalition BACKGR0UNDER i About Us ............................................................................... 3 Our Vision ............................................................................... 4 Our Values ............................................................................... 5 AboutKratom..................................................................... 6 Not All Kratom is Equal......................................................... 6 Kratom Taxonomy................................................................... 7 Kratom is Not an Opioid....................................................... 8 Addiction Profile ...................................................................... 9 RelativeSafety........................................................................... 10 Poison Control Center Statistics ................................... 10 Calls per Substance..................................................... 11 Calls per 100K................................................................. 12 Calls Resulting in Deaths ........................................... 13 CDC, FAERS, and CAERS Data Analyses .............. 14 Summary Comparison Death Rates is Support from Top Scientists ................................................ 16 Moving Forward................................................................. 17 Regulation & Legislation 17 ....................................................... Global Kratom Coalition (GKC) is an alliance of kratom consumers, experts, and industry leaders committed to protecting and expanding access to kratom across the globe. We dedicate resources to advancing scientific research, driving consumer education, and developing robust regulations that are backed by science and protect consumers. GKC focuses on kratom product safety, scientific advancement, and consumer education. Whilst GKC's foundation is based on the traditional use of kratom in Southeast Asia, GKC acknowledges the rise and market demand for kratom extracts in the United States. GKC advocates for the distinction between kratom leaf, extracts, concentrates and isolates, as'not all kratom is equal', while also advocating for regulations designed to ensure that consumers have access to kratom products that are safe. w At.N www.globalkratomcoalition.org 3 info@globalkratomcoalition.org Our Vision We envision a world where kratom products are recognized as a safe and natural option for those seeking to enhance their well-being, supported by a thriving scientific community dedicated to unlocking its potential. We envision a future where consumers have access to high -quality kratom products, fair and reasonable regulations exist for kratom products, and the kratom science flourishes, providing greater understanding and knowledge. ,.A Our Values Access We believe that individuals should have the choice as to how they look after their health and wellness. This choice should be informed by the latest unbiased information available. We work to protect and expand access to kratom products across the world while dedicating resources to advancing scientific exploration so consumers can make informed decisions. Education We are dedicated to providing accurate, evidence - based information about kratom products, and empowering consumers to make informed decisions. Advocacy GKC serves as a united voice for kratom product consumers worldwide, advocating for fair and sensible regulations that prioritize consumer safety, freedom of information, and good manufacturing practices. Consumer choice and safety are at the core of our advocacy efforts. Community We foster a global community of kratom enthusiasts, experts, vendors, and advocates who share our passion for kratom. Together, the community will promote the benefits of kratom and fight for informed and responsible use. The community will drive regulation that protects kratom products and users. Responsibility We promote the responsible use of kratom products and encourage vendors to adhere to strict quality and safety standards, ensuring consumers have access to kratom products that are safe, well - manufactured, and labeled appropriately. DAbout Kratom Kratom is a tropical evergreen tree (Mitragyna speciosa) native to Southeast Asia, where for centuries, it has been used to increase endurance and enhance mood.. Kratom is traditionally consumed in various forms, such as dried powders, fresh leaves, or brewed teas/decoctions. It is often categorized as an herbal supplement in the western world, though its classification varies by region and country. The most well -studied psychoactive compounds found in kratom are called alkaloids. Mitragynine, an indole alkaloid, is the most abundant while of the other alkaloids found in quantifiable amounts include speciociliatine, speciogynine, and paynantheine, among others. These alkaloids interact with receptors in the brain, influencing mood and energy levels. However, due to the complexity of the alkaloids found in kratom, its mechanism of action is not yet fully understood. Not All Kratom is Equal The reason for much of the confusion, conflation, and misinformation that dominates news about kratom is that there is very little understanding that not all kratom is the same. Critically, all products derived from kratom - including leaf material, extracts, concentrates, and isolates - are called "kratom" without consideration of the inherent differences in potency of these product types. Additionally, adulteration of kratom products is prevalent. Some manufacturers have been known to boost their products' 7-hydroxymitragynine content, for example, which can only be accomplished through chemical manipulation.' While others have added synthetic or illicit substances to kratom products resulting in deadly consequences.2 Furthermore, alkaloids from different product types will have different levels of exposure, which may lead to unexpected adverse effects. Unfortunately, reporting of adverse events does not make a distinction between kratom product types which has the effect of lumping all forms together, making it difficult to understand the safety of individual kratom products and provide guidelines for regulation of different product types. GKC is dedicated to educating individuals on the differences in kratom product types and providing definitions to be used by educators, scientists, industry, and regulators so that not all products are called "kratom" moving forward. 1 Lydecker, A.G.; Sharma, A.; McCurdy, C.R.; Avery, B.A.; Babu, K.M.; Boyer, E.W. Suspected Adulteration of Commercial kratom Products with 7-Hydroxymitragynine. J Med Toxicol 2016,12, 341-349. 2 Kronstrand, R.; Roman, M.; Thelander, G.; Eriksson, A. Unintentional fatal intoxications with mitragynine and O- desmethyltramadol from the herbal blend Krypton. 3 Anal Toxicol 2011, 35, 242-247. Taxonomy Acknowledging that the term "kratom" cannot encompass all products derived from Mitragyna speciosa, it is important to develop a clear way of talking about kratom in its various forms. It is also important to distinguish between what is and what is not kratom or kratom derived. GKC endorses distinguishing between Mitragyna speciosa (the tree, i.e. "kratom"), leaf kratom (dried and ground kratom leaf), kratom extracts (that match the alkaloid profile of the leaf) and kratom isolates (isolated specific kratom alkaloids). Kratom derived isolates of individual alkaloids or synthetically derived alkaloids are a cause of concern for the industry. There is not enough known about the use of specific isolated alkaloids or synthetically derived alkaloids to determine their safety. These products cannot be considered under the taxonomy of kratom as they differ too greatly from the plant. This is referenced in the taxonomy diagram below: Kratom Taxonomy Mitragyna Speciosa 1 Fresh leaves used traditionally in Southeast Asia Leaf Kratom Dried ground leaves of Mitragyna Speciosa Kratom Kratom Extracts Isolates Leaf Kratom exposed to solvents to remove fiber and concentrate all alkaloids (extracts) or individual alkaloids (isolate) Kratom is Not an Opioid Leaf kratom is not an opioid, though its compounds, like those of many other substances, interact with the opioid receptor system. When it comes to the opioid receptor system, there are numerous compounds that interact with and activate this system that are commonly consumed, such as many dairy products and compounds ingested from barley and gluten.3 Additionally, sugar triggers the production and release of endogenous opioid compounds.4 Compounds found in kratom products interact with opioid receptors, as well as multiple other receptor system types. The distinction between the function of alkaloids and those of illicit, prescribed opioids lies in their downstream effects. Drugs like heroin and codeine interact strongly with the p-opioid receptor subtype, which triggers G-protein coupled receptors downstream, causing the deleterious side effect of respiratory depression that can lead to overdose. Research into mitragynine, meanwhile, has shown that respiratory depression isn't triggered.s 3 Tyagi, A.; Daliri, E. B.; Kwami Ofosu, F.; Yeon, S. J.; Oh, D. H., Food -Derived Opioid Peptides in Human Health: A Review. Int J Mol Sci 2020,21 (22). 4 Avena, N. M.; Rada, P.; Hoebel, B. G., Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neuroscience and biobehavioral reviews 2008,32 (1), 20-39. 5 Henningfield, J. E.; Rodricks, J. V.; Magnuson, A. M.; Huestis, M. A., Respiratory effects of oral mitragynine and oxycodone in a rodent model. Psychopharmacology 2022, 239 (12), 3793-3804. Addiction Profile While there is a potential for dependence with long-term and frequent use, the abuse potential of kratom is considered lower than that of traditional opioids, and symptoms of withdrawal are mild. Responsible use is key to minimizing risks. In general terms, addiction is defined as a medical disorder. The National Institute on Drug Abuse defines addiction as a "chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences.116 Having a physiological dependence on a substance does not necessarily mean that a person has an addiction to that substance. There are few documented reports of kratom addiction globally. One review of clinical case reports found only 55 cases in which a clinician evaluated, in some manner, symptoms related to leaf kratom physical dependence or addiction -like symptoms.' In regions where kratom is indigenous, Malaysia and Thailand in particular, there have been self -reports of mild to moderate symptoms of craving, tolerance, and withdrawal among people who consume kratom regularly. However, the functioning of these regular consumers does not show clear impairments that would be typical of a substance use disorder or addiction; rather, there is more indication of physical dependence. 8 9 10 11 12 Similar to reports from Southeast Asia, where many use kratom as part of everyday life, the social, psychological, occupational, and daily functioning of people who use kratom in the U.S. does not seem to cause impairment, even in cases where physical dependence signs are present.13 1415 National Institute on Drug Abuse (NIDA). Drug misuse and addiction. (2020, Julyl3). Retrieved December 21, 2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drug-misuse-addiction. Smith, K. E., Feldman, J. D., Schriefer, D., Weiss, S. T., Grundmann, O., Dunn, K. E.,... & Epstein, D. H. (2023a). Diagnostic ambiguities and underuse of clinical assessment tools: A systematic review of case reports on kratom addiction and physical dependence. Current Addiction Reports,l0(2), 282-292. Saingam, D., Singh, D., Geater, A. F., Assanangkornchai, S., Jitpiboon, W., & Latkin, C. (2023). The Health Impact of Long - Term kratom (Mitragyna Speciosa) Use in Southern Thailand. Substance Use & Misuse,1-14. Singh, D., Narayanan, S., & Vicknasingam, B. (2016). Traditional and non-traditional uses of Mitragynine (kratom): A survey of the literature. Brain Research Bulletin,126, 41-46. Singh, D., Muller, C. P., & Vicknasingam, B. K. (2014). kratom (Mitragyna speciosa) dependence, withdrawal symptoms and craving in regular users. Drug and alcohol dependence,139,132-137. Singh, D., Muller, C. P., Vicknasingam, B. K., & Mansor, S. M. (2015). Social functioning of kratom (Mitragyna speciosa) users in Malaysia. Journal of Psychoactive Drugs, 47(2),125-131. Singh, D., Narayanan, S., Muller, C. P., Swogger, M. T., Rahim, A. A., Leong Bin Abdullah, M. F. I., & Vicknasingam, B. K. (2018). Severity of kratom (Mitragyna speciosa Korth.) psychological withdrawal symptoms. Journal of psychoactive drugs, 50(5), 445-450. Garcia-Romeu, A., Cox, D. J., Smith, K. E., Dunn, K. E., & Griffiths, R. R. (2020). kratom (Mitragyna speciosa): user demographics, use patterns, and implications for the opioid epidemic. Drug and alcohol dependence, 208,107849. Smith, K. E., Dunn, K. E., Epstein, D. H., Feldman, J. D., Garcia-Romeu, A., Grundmann, O., ... & Weiss, S. T. (2022a). Need for clarity and context in case reports on kratom use, assessment, and intervention. Substance Abuse, 43(1),1221-1224. Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. T., Grundmann, O., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology,14,1174. Interviews undertaken by researchers at NIDA found that some regular U.S. kratom consumers did not report withdrawal symptoms, whereas others had mild withdrawal, but all described how kratom was a routine part of their daily and weekly routines.1, Individuals who use kratom regularly do not show impairments in daily functioning or hazardous use. This makes sense when we remember that some of the reasons why people use kratom are often to be productive and highly functioning in their everyday lives.17111 A limitation of the current research is that most individuals are using leaf kratom products, so similar studies and interviews must be conducted for other types of kratom products like extracts, concentrates, and isolates. So, while there is presently some evidence to suggest that regular or prolonged use of leaf kratom may result in tolerance or withdrawal and physical dependence, there is no evidence to support assertions that leaf kratom use is resulting in concerning symptoms of compulsive use despite adverse consequences. What seems most likely to occur from regular, prolonged use of leaf kratom, particularly by those who consume large amounts, is dependence, not addiction. Relative Safety On a micro level, kratom, when used responsibly, is considered safe for many individuals. Still, it's crucial to be aware of proper serving sizes, potential side 01 effects, and individual differences in reactions to kratom products. On a macro level, it is important to put any risk posed by kratom in context —specifically by comparing it to the risk profile of other widely used and available substances. Below, the safety and abuse potential of kratom is discussed relative to other substances. Poison Control Center Statistics The following graphs present statistics on calls to U.S. Poison Control Centers between 2017 and 2021, organized by substance (see "Calls per Substance"). When normalized by 100,000 users (see "Calls per 100K Users"), ibuprofen, a substance considered relatively safe, has the most calls to poison control centers, but these calls do not result in death. By far, the most deaths concern opioids, followed by alcohol and antidepressants. There were only 15 calls that resulted in death after kratom ingestion, whereas opioid calls that resulted in death were almost 1,500 in the same 5-year period (see "Calls Resulting in Deaths"). 16 Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. T., Grundmann, O., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology,14,1174. 17 Grundmann, O., Veltri, C. A., Morcos, D., Knightes III, D., Smith, K. E., Singh, D.,... & Swogger, M. T. (2022). Exploring the self - reported motivations of kratom (Mitragyna speciosa Korth.) use: a cross -sectional investigation. The American Journal of Drug and Alcohol Abuse, 48(4), 433-444. 18 Smith, K. E., Dunn, K. E., Rogers, J. M., Grundmann, O., McCurdy, C. R., Garcia-Romeu, A_- & Epstein, D. H. (2022d). kratom use as more than a "self -treatment". The American Journal of Drug and Alcohol Abuse, 48(6), 684-694. Poison Center Calls Per Substance 2017 - 2021 This graph presents the total call numbers for each of the included substances. Calls regarding kratom barely register. Of course, that is partly because kratom is used far less frequently than these other substances. The following graph controls for this context. 200000 2017 2018 2019 2020 2021 150000 100000 1001916191 e \a�e� J��a eJe O� Quo eQ d o �O G GG P e� o a P oNG r /\o� Source: American Association of Poison Control Centers o�\ IPoison Center Calls Per 100K Users 2017 - 2021 This graph presents call numbers as proportions of 100,000 users of each substance. Again, calls for kratom incidents barely register, comparing most closely with calls regarding energy drinks. 600 500 400 300 200 100 0 2017 2018 2019 2020 2021 o� IQ NG P Source: American Association of Poison Control Centers & CDC & SAMHSA user data Poison Center Calls Resulting in Deaths 2017 - 2021 And this graph presents calls that resulted in deaths, again putting the risk associated with kratom consumption in context. 500 400 472 455 300 284 200 125 108 it 100 4 0 35 44 M ■ 9 2017 2018 2019 2020 2021 14191116 10 in P 7115 6 2 4 1 1 1 4 4 1 1 1 4 20 10 11 1 0 1 1 0 1 0 1 1 0 1 2 3 5 4 A�- ��o\ e����� o a� 10KG dJate\ ��o �o e�� a�a La \� o� ro o\\G ��o�tio o�aGo ��, P � P Source: American Association of Poison Control Centers CDC, FAERS, and CAERS Data Analyses It has been widely reported that kratom deaths are increasing at an "alarming rate." When reviewing the FDA Adverse Event Reporting System (FAERS), the CFSAN Adverse Event Reporting System (CAERS), and the Centers for Disease Control and Prevention databases for kratom-related deaths, it is evident that the majority of deaths associated with kratom are linked to polysu bsta nce use or other mitigating circumstances. This context is graphed below, between 2019 and 2021, showing a declining rate of kratom-only deaths. Kratom Death Analyses 2019 to 2022 —0 2019 2020 2021 2022 t Poly Drug Use M1bed!Cinnreiahhrnces No additional factors erg®19dep-hlD212?nt review of FAERS Summary - Comparison Death Rates 2021 (Normalized Per 100k Users) In the context of overall substance use in the U.S., where sugar is included, the data illustrates that kratom presents a much lower risk than alcohol, tobacco, sugar, and opioids. 40.00 /• •• • •• Tobacco Alcohol Sugar Opioids Kratom Marijuana Kava Source: Nutrasource independent review of FAERS, database 2019 to 2022 Support from Top Scientists Leading scientists endorse the distinction between different kratom product types. Dr. Christopher R. McCurdy_ and Dr. Oliver Grundmann, professors at the University of Florida's College of Pharmacy_, have greatly advanced research into kratom, its compounds, and their potential therapeutic benefits, most recently with their paper "Not all kratom is equal: The important distinction between native leaf and extract products," which published in October 2023. Some important excerpts from this publication include: • "While unaltered kratom leaf material contains the active ingredient mitragynine in amounts of about 2 percent, the recent emergence of kratom extracts has resulted in products containing 40 percent or more mitragynine by weight." • "Products containing kratom extracts may not be available in various formulations, such as tablets, capsules, liquid shots or gummies, that appeal to consumers based on better palatability (circumventing the unpleasant taste of native kratom leaf or powder material). Better taste can lead to the ingestion of higher amounts of mitragynine, raising questions of consumer safety and abuse potential. It is well -documented that kratom misuse can lead to adverse and toxic effects, leading to a dependence described as "kratom use disorder." • "As researchers studying the therapeutic potential of kratom, while also desiring to reduce possible associated harms, we strongly recommend that kratom in its native form (unadulterated fresh or dried leaf materials) remain available to consumers." • "In addition, there must be thorough and proper oversight and regulation, including clear labeling that describes the amount of mitragynine per kratom dose, recommended maximum daily doses, potential for drug interactions, and implementation of proper Good Manufacturing Practices (similar to what is done for other dietary supplements). • "Given the limited scientific data on the risks and toxicity of concentrated kratom products, consumers should approach them with extreme caution and hope for more government oversight." • https://thehill.com/opinion/healthcare/4379508-the-rest-of-the-us-needs-to-follow-floridas- lead-a nd-sta rt-reg u lati ng-kratom-extracts/ GKC is dedicated to maintaining the stance that not all kratom products are created equal and urging further safety research into different product types that are available on the US market. . Moving Forward Regulation Kratom - neither a conventional food nor an approved drug - doesn't fit neatly into any federal regulatory category, which has allowed for holes in oversight. As of December 1, 2023: • Kratom is legal to sell and consume in 44 states. Of those: 0 11 states have passed regulations protecting consumers (i.e., kratom Consumer Protection Acts, or KCPAs) 0 12 states are actively considering regulations protecting consumers • Kratom is illegal to sell and consume in 6 states. Of those: 0 2 states are reviewing their bans Legislation The Global Kratom Coalition (GKC) recognizes that existing state -level legislation does not fully address the complexities of the kratom market nor fully addresses concerns around consumer safety and experiences. The need for more comprehensive legislation is evident to protect consumers and ensure they have access to safe, responsibly manufactured kratom products. Our efforts are geared towards pushing for more rigorous standards and eliminating bad actors from the market. Due to the absence of Federal regulation, it is currently incumbent on states to put forward robust regulations that ensure that manufacturers produce safe products to ensure that consumers maintain safe access to the benefits of kratom. States have moved to pass various bills to ensure that consumers have access to responsibly manufactured and safe kratom products. In California, kratom is currently legal to be sold and consumed, except for in the city of San Diego and the city of Oceanside. The city of San Diego passed ordinance 20657 to ban kratom on June 15th, 2016, citing concerns over public health and safety. However, California legislators have the opportunity in 2024 to move forward with introducing legislation that would regulate leaf kratom products. Legislation from other states offers a vision of what legislation might look like in California. Recently, California Assembly Member Matthew Haney, in consultation with the Global Kratom Coalition, proposed The California Kratom Consumer Protection Act (CKCPA) in the 2024 legislative session. This is a significant step forward as, for the first time, legislation is being put forward that truly takes steps to make the kratom marketplace safer for consumers by: I. The GKC is working on developing science that will determine what a safe serving of kratom is. Once determined, GKC will advocate for instituting limits on the amount of total alkaloids allowed per serving of a kratom product and will make recommendations regarding what is a safe total daily intake of a kratom product. In the meanwhile, GKC will legislate that kratom products have clear serving size directions, and calibrated measuring devices where appropriate. 2. Ensuring that kratom products are adequately labeled to ensure that consumers are informed as to how they should consume the product safely. 3. Establishing enforcement mechanisms and funding for regulations to ensure that regulations are not just put into legislation but are actively exercised to ensure that vendors are not running foul of the stipulations put forward. 4. Require manufacturers to follow cGMP rules that, if not followed, will result in manufacturers having their permit to sell kratom revoked in the state. The GKC believes that stringent regulations are an absolute requirement to ensure that consumers maintain access to safe kratom products that can be of significant benefit to their everyday lives. The GKC will actively pursue stringent regulation in all states across the US. Received After Agenda Printed March 12, 2024 Agenda Item No. 3 IsLAW ENFORCEMENT ACTION PARTNERSHIP ADVANCING JUSTICE AND PUBLIC SAFETY SOLUTIONS EXECUTIVE DIRECTOR March 11, 2024 Re: NB Ordinance NO. 2024-5 sutenant Diane Goldstein, Ret. Nevada, USA — Position: Oppose BOARD OF DIRECTORS Joe Stapleton Chief Brendan Cox, Ret. Chair, New York, USA District 1 — Mayor Pro Tern )puty Chief Wayne Harris, Ret. Treasurer, New York, USA Brad Avery Kristin Daley, CA District 2 — Councilmember ecretary, Massachusetts, USA Professor Jody Armour Erik Weigand Secretary, California, USA District 3 — Councilmember Sergeant Terry Blevins, Fmr. Arizona, USA Robyn Grant District 4 — Councilmember Chief Mike Butler, Ret. Colorado, USA Noah Blom Captain Michael Harvey, Ret. District 5 — Councilmember Virginia, USA udge Arthur L Hunter, Jr„ Fmr. Lauren Kleman Louisiana, USA District 6 — Councilmember Ms. Nadine Jones New Jersey, USA Will O'Neill Thomas Schoolcraft District 7 — Mayor Transitions Coordinator Minnesota, USA Matthew Simon Dear Mayor O'Neill and Councilmembers: New Hampshire, USA Chief Thomas N. Thompson I write today in opposition to the proposed Ordinance No. 2024-5, Ohio, USA Prohibition of the Sale and Distribution of Kratom. In my 25 years of service in the Orange County courts, I valued two principles. First, the �upt. Richard Van Wickler, Ret. Chair, New Hampshire, USA evidence must guide our decisions, not opinions of parties who have their own agendas. Second, our decisions should not do more harm Det. Neil Woods, Fmr. than good as we protect the interests of the public. iffordshire Moorlands, England LEAP UK The U.S. Food and Drug Administration ("FDA") has made three specific attempts to have kratom's constituents, mitragynine and 7- hydroxymitragynine, classified as LawEnforcementActionPartners hip.org Formerly known as Law Enforcement Against Prohibition Schedule I substances. Based on current science, leading independent public health officials have reviewed the current evidence and data on kratom and concluded that kratom is not a candidate for scheduling at the federal or international level. Specifically, Dr. Brett Giroir, former Assistant Secretary of Health at the U.S. Department of Health and Human Services ("HHS") during the Trump Administration, wrote a scathing withdrawal letter on August 16, 2018, that highlighted a warning that I believe should be heard by each of you: "Furthermore, there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I ..." The entire premise of the proposed Ordinance is found in the outdated statements made by the FDA that kratom is dangerous. The Agency themselves admitted their position is incorrect in a federal court case the FDA itself initiated against a kratom importer in the U.S. District Court of Southern California. When ordered by the judge to appear at a Hearing to provide witnesses and documents on the claims by the FDA that kratom is "dangerous" the FDA refused on the basis they themselves "have not yet made a determination whether kratom is dangerous."' More to the point, the FDA itself just completed what is known as a Single Ascending Dose ("SAD") study on whether kratom can be safely consumed by humans, and an abstract of the results of that study were reported at the 3rd International Kratom Symposium in Orlando, Florida on February 16, 2024. This study concluded that "kratom appears to be well tolerated in humans at all dose levels." This key finding cleared the solicitation by the FDA for proposals to conduct a Human Abuse Potential ("HAP") study to determine whether kratom use results in dependency or addiction, and the severity if indicated. The notice for solicitation for the HAP study was issued on January 16, 20242. This study is expected to be completed in 2-4 years. In the SAD study, the FDA found that only two human subjects of the 40 participants experienced nausea only after the consumption of 12 grams of kratom, 24 capsules, within 5 minutes. None of the subjects reached the study's "stopping criteria" that would have resulted in termination of the study. The DEA designated kratom as a drug of concern following the rejection of the recommendation by the FDA to classify kratom as a Schedule I substance in 2016. That designation is appropriate for the role the DEA plays in monitoring substances of concern in the United States. It is important to note the DEA has never designated kratom in any of the National Drug Threat Assessment ("NDTA") reports. The NDTA is a comprehensive strategic assessment of the threat posed to the United States by domestic and international drug trafficking and the abuse of both licit and illicit drugs. The report combines federal, state, local, and tribal law enforcement reporting; public health data; open -source reporting; and intelligence from other government agencies to determine which substances and criminal organizations represent the greatest threat to the United States. 1 Case 3:23-cr-00179-TWR Filed 12/06/23 Page ID.1032 Exhibit 6; United States of America, Plaintiff, v. Nine2Five, LLC (1) Sebastian Guthery (2), Defendants 2 https://grants.gov/search-results-detail/351644 LawEnforcementActionPartners hip.org Formerly known as Law Enforcement Against Prohibition Kratom does not now, nor has it ever, met the criteria for inclusion in the DEA's NDTA report. National Institute on Drug Abuse ("NIDA") Director Nora Volkow has testified before Congress that kratom should not be banned but rather regulated appropriately and new research should be undertaken. NIDA currently has funded more than $90 million in grants for kratom research. NIDA researched the FDA claims that kratom caused deaths, and concluded those deaths were largely from polydrug use or adulterated kratom products. The NIDA message is that kratom is a harm reduction tool that should be available to consumers. The science on kratom speaks equally powerfully on its value for consumers, and the FDA's own research proves pure and unadulterated kratom is not dangerous to consumers. The problem is adulterated kratom products that have entered the marketplace, and eleven states have passed legislation to regulate kratom products to assure consumer safety. Similar legislation is now before the California Legislature. In addition, there is a Federal Consumer Protection Act sponsored by U.S. Senator Mike Lee (R-UT) and Congressman Jack Bergman (R-MI), and Senator Cory Booker (D-NJ) and Congressman Mark Pocan (D-WI). This bipartisan effort will protect the American public with responsible regulations to protect the public from adulterated kratom products. Congressman Bergman is a retired Marine Corps lieutenant general and is a fierce advocate for protecting servicemembers and veterans who have returned from service with injuries and chronic pain. I hope you will listen to Congressman Berman's message that was published in The Hill newspaper: "But today, the recovery of millions of veterans is threatened by an overreaching federal government. Three times in the last decade, the U.S. Food and Drug Administration (FDA) has attempted to force kratom into Schedule 1 of the Controlled Substances Act, a drastic action that would essentially criminalize the use of the supplement nationwide and harm countless Americans who have benefited from kratom for decades. The FDA, which has a long-standing bias against any supplement that is not a pharmaceutical that can profit Big Pharma and their own budget, has pushed for kratom to be labeled a Controlled Substance by misstating the science, ignoring kratom's long history of safe use, and falsely claiming kratom has the same effects as classic opioids.113 Evidence should guide your decision, and we should not do more harm than good. Those principles served me well for 25 years, and they will serve you well on this issue as well. Sincerely, Judge James P. Gray (Ret.) Orange County Superior Court CC: Chief Joseph L. Cartwright 3 https://thehill.com/opinion/congress-blog/4125241-lets-prevent-the-feds-from-jeopardizing-veteran-addiction-recovery/ LawEnforcementActionPartners hip.org Formerly known as Law Enforcement Against Prohibition Received After Agenda Printed March 12, 2024 Agenda Item No. 3 Dear City Council, My name is Mousa Kakish, I am a business owner in the beautiful city of Newport Beach, and have been in business here for nine years. I own a smoke shop right there just a few blocks North of the Pier off Newport Blvd, it's Up in Smoke. I'm proud to say, we have been part of this community for years now, have learned to love all aspects of this city and everything Newport Beach has to offer. We always pay our taxes, support the businesses in our neighborhood, and ever operated our business honestly. We've never had any problems with the city, and they have never had a problem with us. It was a complete shock when it was brought to my attention by a person who attended the last city council meeting, that Ordinance No 2024-25 was drafted and introduced to be passed on March 12th. Under this ordinance, you intend to ban the sales and distribution of Kratom within the city of Newport Beach. This Ordinance was introduced only a few weeks ago, ostensibly without any public comment or discussion on Kratom, and it has ramifications that not only affects the community members itself but businesses such as mine that consider ourselves part of this community. I read through the City Council Meeting Minutes for the past year, and not one mention of Kratom being a public nuisance, or even rather a public point of discussion has occurred. To pass this type of ban with such finality and without further investigation into the positives of Kratom withal, seems a gross misuse of city powers. I am sure you have received plenty of emails from people in the community who have voiced their displeasure with the introduction of Ordinance No 2024-25. Many will show up to the meeting on March 12th to voice their displeasure with your stance. There are people who have various needs and uses for Kratom, for it has been proven to be an alternative solution to painkiller and stimulants. We first started carrying Kratom for an older gentleman, 67, former college football player, in his early 60s. He was fed up with the prescription drugs he was taking giving because they messed with his energy and mood levels. He did his research and suggested this alternative herb called Kratom. We did our research too, and ever since, have expanded our inventory and have various customers that use Kratom in a safe and practical way. The FDA has had its negative outlook on Kratom, and it has mischaracterized the plant as being a dangerous plant akin to more serious drugs. The fact remains that Kratom is in fact not an opioid, but it triggers the receptors and acts as a natural pain killer in larger dosages. We have customers and friends that suffer from various illnesses, ranging from Sciatic pain to chronic spinal problems to Crohn's Disease. These people live with pain, and a natural plant, literally related to the coffee plant, is the one thing that helps them. Kratom is the one thing that allows them to manage the pain without the detrimental side effects of pharmaceuticals, or worse, illegal controlled substances. There are even those who have used Kratom to deal with addiction and overcome serious drugs. There currently is a fentanyl epidemic, with the drug infiltrating every sort of street drug imaginable. I have had friends and known people in the community who have overdosed on fentanyl, either from having laced product, counterfeit pills, or even took the drug knowing what it is. How can the city council in good conscience ban a plant, an herb ground up and consumed in powder or encapsulated, a natural alternative to far worse? With far more pressing problems plaguing our city, to go after something like Kratom seems counterproductive to Harm -Reduction policies. I have no doubt in my mind that the city council is operating with the city's best interest in mind. There was a story or maybe research that suggested Kratom is a problem in communities and is in cahoots with serious drugs, but Kratom is something that has garnered a bad reputation due to efforts from pharmaceutical companies seeking to eliminate a natural alternative to Big Pharma. Kratom helps save people's lives, helps with the management of pain for those with illnesses looking for an alternative to drugs, and it merely a plant. There is a responsible way to consume Kratom, a responsible way to distribute and sale it, and a responsible way for a representing body to address the freedoms and liberties of its constituents. You can be a good person and well-intentioned, and still be wrong. With all the misinformation out there, it is easy to have been led astray or convinced of something. Our politics and daily discourse are mired with misinformation. Don't let the misinformation about Kratom affect city policy and affect a community that is giving you an alternative perspective to your charts. Even the FDA has recently taken its step back against Kratom and published new findings, because it is in fact just a plant with properties that alleviate pain. I believe the City Council should consider the voices reaching out to them in protest of Ordinance No 2024-25. These voices are members of this community that have faces, and problems, and actual needs that the City Council is ignoring with the passing of this Ordinance. You are also ignoring an entity of this community, Up in Smoke, as well as many others that both sale and are large distributors of Kratom within your city limits. This Ordinance is said to have no fiscal impact on the community, but you will be driving businesses out, costing the city Tax Dollars that will only be spent up the street in Costa Mesa where Kratom remains unbanned. There are workforces and people within these businesses that this bill, advertently or inadvertently targets, that too spend money and pay their taxes within the City of Newport Beach. They also have lives and this Ordinance affects businesses that pay for livelihoods and employees. Please reconsider your positions, and at least, allow there to be an honest conversation about Kratom that involves the community; a conversation that happens in front of open doors and considers the voices of the constituents. I will admit that Kratom can be abused if taken to excess, but it does not kill, facts stating such are misleading. But we then must also admit that things like sugar can be abused, alcohol can be abused, and even a thing called Power can be abused. Don't let this hasty decision undermine the liberties of democracy and republic. Consider the voters and the population you represent. To pass this ordinance so hastily, so nonchalantly, as if it isn't infringing on a person's personal freedom to consume Kratom to live a better life, is to deny the faces and voices of the people you represent. - Yours Truly, Mousa Kakish Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: loraromney(ftmail.com To: City Clerk"s Office; DDe t - City Council Subject: Prohibition of Kratom - Ordinance No. 2024-5: Adding Chapter 10.75 Date: March 08, 2024 3:59:02 PM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the late. I am writing this email to voice my opinion that I DO NOT support the prohibition of the sale and distribution of kratom. I am a pain patient of 13 years. I have a rare facial nerve condition called Trigeminal Neuralgia. It causes me severe and constant burning nerve pain on the top half of my face. It is debilitating. Without pain control, I am unable to function. For years I was allowed two opioids per day to manage my pain. It was not enough due to the fact that these meds only last 4-5 hours. I was in horrific pain once I had used the pills I was allowed for the day. I had to choose whether or not to sleep at night or to function in the day. I discovered kratom 7 years ago. It was life changing for me. I was able to immediately stop taking oxycodone and only take kratom to control my pain. I now only take an opioid 2-3x per month in a very severe flare. Kratom keeps my pain at manageable levels without side effects that many meds gave me. It does not cause me to have any "high" or drugged feeling. In fact, kratom helps me feel normal again! I now fully participate in life due to the pain control that kratom gives me. I work part time, serve on the board of two non-profit organizations, play my flute in a community band, volunteer in my church, and I can be a good mother and grandmother! Kratom is truly a blessing to me. It is important to note that I still only consume a very small dose for those who use it for pain control (approximately 8 grams per day). Please do not stop the sale and distribution of kratom in your city. Patients like me should be able to access this plant and not be afraid that possession of this supplement could result in illegal activity. The opioid crisis is very real. Kratom is a solution, not a problem. Please protect this plant supplement for people like me. Instead of prohibiting sale and distribution of this supplement, please support legislation (Kratom Consumer Protection Act) that requires vendors to test their product for purity. This law also prohibits the sale to minors. I live in Utah, but I visit California (and even Newport Beach) every year or so. This is personal for me. I am a law-abiding citizen, and I should be allowed to access and utilize a plant that helps keep me functioning in life again. Thank you for your consideration of this very important issue. Lora Romney 2154 Oak Lane Layton, UT 84040 801-557-1144 81 Virus-free.www.avast.com Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Talis Abolins <talis.abolins@gmail.com> Sent: March 08, 2024 4:28 PM To: City Clerk's Office; Dept - City Council Subject: Ordinance No. 2024-5 - Kratom Ban Attachments: 240112 McKibban Amended Complaint.pdf; EX 00148 Kratom Risk of Death 63.pdf; 04 00152 Krantz Bar Chart.pdf, 240305 Pinney Associates - TobaccoTactics.pdf; 2023 - Li, An Eval of Adverse Drug Reactions and Outcomes - Kratom.pdf Hello, I want to offer support for your wise effort to protect consumers from kratom in Newport Beach. I have dedicated the past three years of my life to helping survivors of those whose loved ones were killed by this kratom industry. Remarkably, this industry is based on a product that is per se adulterated under federal law. I am attaching important background confirming that kratom is already banned under federal FDA statutes and regulations; and is recognized by numerous independent published articles for its dangers and lack of established medical use. Please let me know if there is a way to appear and comment, or if you have any questions about available resources on this subject. The AKA lobbying machine is very powerful, and you will be inundated with their pro-kratom campaign. Do not be swayed by kratom funded science or the misleading "consumer protection" provisions they offer to try and legitimize their adulterated product lines. Thank you. Talis Abolins 253 686 5175 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 IN THE SUPERIOR COURT OF THE STATE OF WASHINGTON IN AND FOR COWLITZ COUNTY RACHEL McKIBBAN, individually and as Personal Representative of the Estate of JORDAN McKIBBAN, deceased; Plaintiffs, I vs. JOPEN, LLC, Texas limited liability company; JOHNSON FOODS, LLC, a Wyoming limited liability company; LP IND., LLC, a Wyoming limited liability company; CAG HOLDINGS, LLC, a Wyoming limited liability company; RMH HOLDINGS, INC., a Wyoming corporation; OLISTICA, an unincorporated association; MIT THERAPY INC., an Idaho corporation; DURITY DISTRIBUTION, INC., an Idaho corporation; HUSH WORLDWIDE LLC, a Wyoming limited liability company; DRIP DROP DISTRO LLC, an Idaho limited liability company; BEDROCK MFG LLC, a Wyoming limited liability company; CLOUD HOUSE VAPORZ, INC., a Washington corporation; AMERICAN KRATOM ASSOCIATION, a Virginia non-profit corporation, and JOHN & JANE DOES 1 THROUGH 10. AMENDED COMPLAINT - 1 Defendants. NO. 23 2 01183 08 AMENDED COMPLAINT FOR WRONGFUL DEATH mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 COMES NOW the above -named plaintiff, by and through her attorneys of record, Talis Abolins and Michael Cowgill of mctlaw; and alleges the following in support of her claims: II. PARTIES 1. ESTATE OF JORDAN McKIBBAN ("Jordan"). The Estate of Jordan McKibban has been opened in a probate action by the Cowlitz County Superior Court. Jordan McKibban was a single man who, until the time of his death, resided in Cowlitz County, Washington. Before his death he was a single, hardworking man in industrial shipping and receiving, and loving son to his parents and brother to his siblings. 2. RACHEL McKIBBAN is Jordan's sister and the duly appointed Personal Representative of his Estate. She was and is a resident of Kalama, Cowlitz County, State of Washington. She brings claims on behalf of the Estate and its beneficiaries, including herself; Pam Mauldin, Jordan's mother; Dennis McKibban, Jordan's brother; and Dennis McKibban, Jordan's father. 3. Defendant JOPEN, LLC (doing business as Al Wholesale; Party Nuts; Party Nuts Distributions; Uziel; Innovo Activas; and Evolutionary Organics) ("JOPEN") was and is a Texas -based Limited Liability Company, that also conducts business in Colorado and Georgia. On information and belief, Plaintiff alleges that affiliates, members, and managers for JOPEN's "WHOLE HERBS" branded kratom activities include Aether, LLC; Aghosh Corp.; Eyal Gabbey; Peyton Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. On further information and belief, Plaintiff alleges that JOPEN conducts its kratom activities as a part of the larger Olistica kratom enterprise, which operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, AMENDED COMPLAINT - 2 mctlaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 including but not limited to: LP; CAG; RMH HOLDINGS, INC.; Lunar Labs LLC; Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Beeman Inc.; Uziel LLC; 1199 Industrial LLC; 1100 Alpha LLC; Engaged Investments LLC; Eyal Gabbey; Petyon Shea Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. 4. Defendant JOHNSON FOODS, LLC (doing business as Olistica Life Sciences Group; Olistica Group; Olistica; OPMS; Companion Agriculture; Companion AG; Jordan Process; Cascade Naturals; Della Terra Pharmaceuticals; Cannopy Corp.; and Canopy Corp.) ("JOHNSON FOODS"), was and is a Wyoming Limited Liability Company. On information and belief, JOHNSON FOODS conducts its kratom activities as a part of the larger Olistica- OPMS kratom enterprise, which operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, including but not limited to: CAG; JOPEN; RMH HOLDINGS, INC.; LP; Lunar Labs LLC; Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Eyal Gabbey; Peyton Shea Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. 5. Defendant LP IND., LLC (doing business as Olistica Life Sciences Group; Olistica Group; Olistica; OPMS; Companion Agriculture; Companion AG; Jordan Process; Cascade Naturals; Della Terra Pharmaceuticals; Cannopy Corp.; and Canopy Corp.) ("LP"), was and is a Wyoming Limited Liability Company with kratom operations in Colorado and Georgia. On information and belief, LP conducts its kratom activities as a part of the larger Olistica-OPMS kratom enterprise, which operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, including but not limited to: CAG; JOPEN; RMH HOLDINGS, INC.; Lunar Labs LLC; AMENDED COMPLAINT - 3 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Eyal Gabbey; Peyton Shea Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. 6. Defendant CAG Holdings, LLC (doing business as CAG Holdings CO, LLC; Olistica Life Sciences Group; Olistica Group; Olistica; OPMS; Companion Agriculture; Companion AG; Jordan Process; Cascade Naturals; Della Terra Pharmaceuticals; and Canopy Corp. ("CAG"), was and is a Wyoming Limited Liability Company, that is both registered and conducting kratom business operations in Colorado. On information and belief, CAG conducts its kratom activities as a part of the larger Olistica-OPMS kratom enterprise, which operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, including but not limited to: LP; JOPEN; RMH HOLDINGS, INC.; Lunar Labs LLC; Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Eyal Gabbey; Petyon Shea Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. 7. Defendant RMH Holdings, LLC (doing business as Olistica Life Sciences Group; Olistica Group; Olistica; OPMS; Companion Agriculture; Companion AG; Jordan Process; Cascade Naturals; Della Terra Pharmaceuticals; and Canopy Corp. ("RMH"), was and is a Wyoming Limited Liability Company, that is both registered and conducting kratom business operations in Colorado. On information and belief, CAG conducts its kratom activities as a part of the larger Olistica-OPMS kratom enterprise, which operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, including but not limited to: LP; JOPEN; CAG HOLDINGS, INC.; Lunar Labs LLC; Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Eyal Gabbey; Petyon Shea Palaio; Mark Jennings; Mark Reilly; and Jacob Fletcher. AMENDED COMPLAINT - 4 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 8. Defendant the OLISTICA LIFE SCIENCES GROUP (also doing business as Centralized Services; Olistica; Olistica Group; Interactive Earth Sciences Corp.; Liv Group Inc.; Cascade Naturals; Johnson Foods, LLC; Della Terra Pharmaceuticals ("Della Terra"); NP Pharma Holdings, LLC; OPMS; Choice Organics; LP IND., LLC; Jordan Process ("Jordan"); Precision Biologics; CAG HOLDINGS, LLC; RMH HOLDINGS, INC.; Cannopy Corporation; JOPEN; Al Wholesale; Party Nuts; Party Nuts Distributions; Innovo Activas; and Evolutionary Organics) ("OLISTICA") is an unincorporated association of kratom business interests that operates through a secretive web of affiliates, individuals, shell companies, alter egos, business names, assumed names, and/or trade names, including but not limited to: LP; CAG; RMH HOLDINGS, INC.; Lunar Labs LLC; Martian Sales, Inc.; Shaman Supplies, LLC; Kono Labs; Highway 160 Way LLC; PFI LLC; Nuza LLC; Nuza; Nuza Logistics; Calibre Manufacturing LLC; Advanced Nutrition; 1099 Industrial LLC; 1100 Alpha LLC; Hush Worldwide LLC; Eyal Gabbey; Petyon Shea Palaio; Mark Jennings; Mark Reilly; Dina Hemminger; and Jacob Fletcher. 9. Defendant MIT THERAPY INC. ("MIT THERAPY") was and is an Idaho -based Corporation with its principal place of business in Boise, Idaho. MIT THERAPY is a wholesaler and seller of kratom products that are manufactured in Southeast Asia by persons beyond the jurisdiction of the court. On information and belief, Plaintiff alleges that affiliates, members, and managers responsible for MIT THERAPY kratom activities include DURITY; PurKratom; Ultra Products LTD; Evan Drake Fischer; and Rachael Bahrenfuss. 10. Defendant DURITY DISTRIBUTION INC. (doing business as Durity; Durity Vape; Durity Smoke & Vape; Durity Vape and Smoke; and/or Durity Vape & Smoke (2); and AMENDED COMPLAINT - 5 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 formerly known as Durity Distribution LLC) ("DURITY") was and is an Idaho -based Limited Liability Company with its principal place of business in Boise, Idaho. DURITY is the purported distributor of MIT THERAPY kratom products. On information and belief, Plaintiff alleges that affiliates, members, and managers, responsible for DURITY kratom activities include MIT Therapy; Rachael Bahrenfuss; Mason R. Kluge; and Evan Drake Fischer (aka Drake Fischer). 11. Defendant HUSH WORLDWIDE LLC (doing business as Hush, and Hush Kratom) ("HUSH") was and is a Wyoming Limited Liability Company, with a foreign registration in Idaho, with its principal place of business in Boise, Idaho. HUSH is a kra On information and belief, Plaintiff alleges that affiliates, members and managers responsible for HUSH kratom activities include: Alluvion, LLC; DRIP DROP DISTRO; BEDROCK; Douglas T. Campbell, Jr.; Troy Palmer; Matthew "Motu" Nu'uvali; Michael Larson; and Mark Ciccarello. 12. Defendant DRIP DROP DISTRO LLC (formerly known as Merica Distribution LLC) ("DRIP DROP DISTRO") was and is an Idaho Limited Liability Company, with its principal place of business in Boise, Idaho. On information and belief, Plaintiff alleges that affiliates, members and managers responsible for DRIP DROP DISTRO kratom activities include: HUSH; BEDROCK; HFO, LLC; Douglas T. Campbell, Jr.; Troy Palmer; and Matthew "Motu" Nu'uvali. 13. Defendant BEDROCK MFG LLC (doing business as Bedrock Manufacturing; and BDRK MFG) ("BEDROCK") was and is a Wyoming Limited Liability Company, with a foreign registration in Idaho, and its principal place of business in Boise, Idaho. On AMENDED COMPLAINT - 6 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 information and belief, Plaintiff alleges that affiliates, members and managers responsible for BEDROCK'S kratom activities include: HUSH; DRIP DROP DISTRO; Vanguard Enterprises, LLC; Troy Palmer; Josh Palmer; and Douglas T. Campbell. 14. Defendant CLOUD HOUSE VAPORZ, INC. (doing business as Cloud House, Cloud Vaporz, and Natures Kratom) ("CLOUD HOUSE"), was and is a Washington based corporation with its principal place of business in Woodland, Cowlitz County, Washington. The member and manager responsible for CLOUD HOUSE kratom activities is CHANNING PLOURD. 15. Defendant AMERICAN KRATOM ASSOCIATION ("AKA") is a Virginia non- profit corporation with its principal place of business located at 13575 Heathcote Blvd. Ste, 320 Gainesville, VA 20155. 16. Defendants JOHN AND JANE DOES l THROUGH 10 are individuals and/or entities whose names and addresses are unknown, but who have directly and personally participated (separately or as alter egos, agents, joint venturers and/or predecessors) in the wrongful import, manufacture, distribution and/or sale of the kratom product, described more fully below. III. JURISDICTION AND VENUE 17. This Court has original subject matter jurisdiction pursuant to the Constitution of the State of Washington, Article 4, Section 6. Jurisdiction is proper in the Superior Court of the State of Washington because the Plaintiff and Defendant CLOUD HOUSE VAPORZ, INC. are Washington residents, and Defendant CLOUD HOUSE VAPORZ, INC. sold kratom to Jordan McKibban in Washington, contributing to his injuries and death in Washington. AMENDED COMPLAINT - 7 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 18. This Court has personal jurisdiction over the non-resident Defendants pursuant to the 141 Amendment of the United States Constitution and Washington's long arm statute, RCW 4.28.185. Each defendant has aggressively marketed, distributed, sold, and/or otherwise promoted kratom products into Washington, for consumption by Washington consumers, such that they have minimum contacts with the state. These defendants' interstate kratom activities involve the transaction of business and the commission of tortious acts within Washington. These defendants are subject to the jurisdiction of the Washington courts as a matter of fair play and substantial justice to Washington consumers who are and continue to be exposed to their injurious and wrongful activities. 19. Venue is proper in the Cowlitz County Superior Court pursuant to RCW 4.12.020 and RCW 4.12.025 in that the Plaintiff's injuries and cause of action arose in Cowlitz County; in addition, Cowlitz County is where Defendant CLOUD HOUSE VAPORZ, INC. and CHANNING PLOURD resides, transacts business, and committed torts upon which these claims are based. IV. INTRODUCTION 20. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 21. Kratom is a complex and powerful substance that is toxic to multiple organ systems 22. Across the nation, a growing number of death certificates have formally establishes deaths caused or contributed to by the "Toxic Effects of Mitragynine (Kratom)". 23. Cowlitz County is already familiar with the tragic toll of Kratom. 24. On July 18, 2023, a Cowlitz County jury issued a verdict of $2,500,000. The jur) AMENDED COMPLAINT - 8 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 held the Kratom seller responsible under the Washington Product Liability Act (WPLA) Consumer Protection Act (CPA). (Cowlitz County Cause No. 20-2-00874-08). 25. Now, another Cowlitz County family must seek justice for a tragic death caused the "Toxic Effects of Mitragynine (Kratom)". 26. The Plaintiffs respectfully ask this Court to hold these Defendants accountable the painful losses they have caused, and to issue a preliminary and permanent injunction barr these Defendants from the distribution and sale of Kratom in Washington. V. STATEMENT OF FACTS 27. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 28. Kratom is the name given to botanical products derived from the leaves of the Mitragyna Speciosa tree, which grows in Southeast Asia. 29. While the nature and extent of Kratom's impact upon human physiology remains largely unknown, medical and scientific research confirms that the powdered Kratom sold in the United States is far more dangerous than other natural products that are sold over the counter. 30. Kratom contains dozens of psychoactive compounds or alkaloids, many of which are not understood. The two most -studied alkaloids are mitragynine and 7- hydroxymitragynine. These two alkaloids bind to the same opioid brain receptors as morphine. Like opiates, these compounds can lead to analgesia (release of pain), euphoria, and sedation. 31. Kratom was not marketed as a dietary ingredient in the United States before AMENDED COMPLAINT - 9 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 October 15, 1994, and is therefore a "new dietary ingredient" under industry standards. 32. As a new dietary ingredient, Kratom must not be marketed or sold for human consumption without premarket verification that it is safe for that purpose. 33. None of the Defendants have ever satisfied the basic industry standard for establishing that Kratom is safe for human consumption before marketing it. 34. The most recent attempt by the kratom industry to legitimize its illegal kratom products occurred on October 21, 2022. On that date, JOHNSON FOODS submitted its "New Dietary Ingredient Notification for NPI-001, a Dried Leaf Powder". 35. When this Notification was submitted, JOHNSON FOODS (and the affiliated WHOLE HERBS DEFENDANTS) knew that no such Notification had previously satisfied the premarket safety standards required to lawfully distribute and sell kratom in the United States. 36. Like premarket notifications before it, the JOHNSON FOODS New Dietary Ingredient Notification for the kratom powder was inadequate, incomplete, and incompetent to satisfy the important standards of premarket safety necessary for the safe marketing, distribution and sale of over-the-counter kratom. 37. The JOHNSON FOODS' New Dietary Ingredient Notification was insufficient under the industry standards for the safe marketing, distribution or sale of botanical ingredients and supplements. 38. A growing body of independent scientific and medical research and literature confirms that no form of psychoactive kratom will ever satisfy the basic standard of premarket safety when it comes to over-the-counter sale of kratom for human AMENDED COMPLAINT - 10 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 consumption. 39. Rather than safe, Kratom is known to cause a wide range of adverse events, including: nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, addiction, severe withdrawal, heart arrhythmias, respiratory depression, seizures, drug -drug interactions, overdose, and death.' 40. According to recent research, Kratom is 63 times more deadly than other natural products that are sold to American consumers.2 41. Thus, it is not scientifically possible for Kratom sellers to verify that their products are safe for human consumption when sold over the counter like coffee, tea, or other natural products. 42. Unable to verify kratom's safety, the Kratom industry has instead been built upon clandestine and fraudulent business activities, including the unlawful importation of Kratom as "plant food", "incense", "cosmetic" powders, and other legal items.3 43. For years, Federal agencies (and courts) have attempted to protect the public by seizing Kratom and taking other civil and criminal actions against Kratom importers, distributors, and those who illegally sell Kratom as an unapproved replacement for ' See, e.g., Xiaotong Li, et al., An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021 (Clinical and Translational Science, 00:1-10; 2023); Mori J. Krantz, et al, Ventricular Arrhythmias Associated With Over -the -Counter and Recreational Opioids (Journal of American College of Cardiology, Vol. 81, No. 23, 2023); Donna Papsun, Forensic Implications of Kratom: Kratom Toxicity, Correlation with Mitragynine Concentrations, and Polypharmacy (Current Addiction Reports; published online May 19, 2023) 2 Xiaotong Li, et al., An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021 (Clinical and Translational Science, 00:1-10; 2023); s See FDA Import Alert # 54-15 (https://www.accessdata fda.gov/cros ia/importalert 1137 html) (last accessed October 23, 2023). AMENDED COMPLAINT - 11 mctlaw 1325 4tn Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 significant medical conditions such as chronic pain, anxiety, addiction, or withdrawal.4 44. In addition to enforcement actions at the national level, an increasing number of states and cities have passed laws making Kratom illegal at the local level. 45. Despite these efforts, the industry is successfully smuggling billions of dollars worth of Kratom across the border. Once it gets past customs and border officials, the Kratom is quickly channeled into chains of distribution managed by individuals and entities generating huge profits from millions of consumers. Despite the serious risks of kratom use, profit -seeking companies continue to market kratom products with unproven and deceptive claims about its safety and ability to cure, treat or prevent medical conditions and diseases. The FDA's examples of illegal claims include statements such as: "many people use kratom to overcome opiate addiction," and kratom is frequently used "as a natural alternative" to treat various health conditions, replacing opiate prescriptions.5 46. Because kratom is adulterated, many of the leading kratom businesses conceal their identities and activities behind mysterious and evolving shell companies, and misleading labels. 47. Each Defendant in this case has profited from unfair and deceptive business practices by promoting, distributing and/or selling dangerous Kratom products to Washington residents. a See Seizures and Injunctions Health Fraud ( https://www fda.eov/consumers/health-fraud-scams/seizures-and- in junctions -health- fraud ) (last accessed October 23, 2023); FDA Statement, Advisory about deadly risks associated with kratom (https://www fda.�zov/news-events/press-announcements/statement-fda-commissioner-scott- ottg lieb- md-fda-advisory-about-deadly-risks-associated-kratom ) (last accessed October 23, 2023); s See FDA News Release, FDA issues warnings to companies selling illegal, unapproved kratom drug products `IIL 3://www lua.rV V/ucw J-cy c11LJ/tit wJ-allllyuul✓c1uc11 �J�lua-1JJuw-wallll kratom-drug-products-marketed-opioid) (last accessed October 23, 2023). AMENDED COMPLAINT - 12 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 48. The WHOLE HERBS kratom is imported, packaged, distributed, and sold through the complex web of companies referred to herein as the OLISTICA enterprise. These companies include Defendants OLISTICA, JOPEN, JOHNSON FOODS, LPI, CAG and RHI (the "WHOLE HERBS DEFENDANTS"). 49. The OLISTICA enterprise (part of which includes the WHOLE HERBS DEFENDANTS) is one of the largest kratom distributors in the United States, including Washington. 50. The OLISTICA brands include but are not limited to: WHOLE HERBS, OPMS, and Remarkable Herbs. 51. Despite its prominence in the kratom industry, OLISTICA's evasive tactics and abuse of corporate forms has been highlighted by recent investigative reports, as well as public filings in multiple lawsuits and claims brought by those harmed by its misconduct.6 52. One key player in OLISTICA's corporate operations is Peyton Palaio. 53. Mr. Palaio was implicated by criminal investigators as a major manufacturer and distributor of the deadly synthetic known as "Spice"; Palaio was also named as a defendant in a wrongful death lawsuit brought by the parents of a high schooler who drowned after taking Spice.? 54. Through its various alter egos and agents, OLISTICA has supported the 6 See, e.g., Hannah Critchfield, A major US kratom brand relies on a maze of companies. Here's the list, TAMPA BAY TIMES (Dec. 19, 2023) (https://www.tampabay.com/investigations/2023/12/19/major-us-kratom-brand-relies- maze-companies-heres-list/ ); Hannah Critchfield, Helen Freund and Langston Taylor, DEADLYDOSE PART 3: Kratom's path across the US is marked by deception and secrets, TAMPA BAY TIMES (December 17, 2023 (htt2s://project.tampabay.com/investigations/deadly-dose/kratom-industry-opms-sUply-chain-indonesia-florida/ ). 7 Critchfield, DEADLYDOSE PART 3, supra note 6. AMENDED COMPLAINT - 13 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 import, distribution, and sale of three of the most popular kratom brand names on the market: OPMS, Remarkable Herbs, and the WHOLE HERBS product at issue in this case. 55. The WHOLE HERBS DEFENDANTS rely on an evolving web of undercapitalized shell entities and fictitious business names in order to avoid responsibility for deaths and harms caused by kratom. 56. The WHOLE HERBS DEFENDANTS have not procured liability insurance to cover the risk of wrongful death or other injury caused by their dangerous kratom operations. 57. A key individual behind the WHOLE HERBS product is Eyal Gabbay. In 2010, Mr. Gabbay was publicly confronted regarding his sale of dangerous synthetic marijuana products.$ Before they were banned, such products were sold as "K2", "Hush" or "Swerve". 58. In recent years, Eyal Gabbay has played a prominent role with Mr. Palaio, Mark Reilly, and others in the promotion, distribution, and sale of kratom through the WHOLE HERBS DEFENDANTS. 59. HUSH liquid shots are another leading brand of kratom product, generating millions in sales nationwide from their location in Idaho, proclaimed as the kratom capitol of the Pacific Northwest. HUSH is packaged, distributed and sold by Defendants HUSH, DRIP DROP DISTRO, and BEDROCK (the "HUSH DEFENDANTS"). 60. On information and belief, the WHOLE HERB DEFENDANTS have an ownership interest in HUSH DEFENDANTS, and receive profits from the sale of the HUSH s James Ragland, Puff n Stuff Smoke Shop Tells Me To Stufflt, THE DALLAS MORNING NEWS (August 4, 2010) (https://www.dallasnews.com/news/2010/08/04/fames-ra lg and-puff-n-stuff-smoke-shop-tells-me-to-stuff-it/). AMENDED COMPLAINT - 14 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 products in Washington to Washington consumers. 61. Like the WHOLE HERBS DEFENDANTS, the HUSH DEFENDANTS are backed by individuals who appear to have experience dealing with deadly synthetic products. 62. The owners of DRIP DROP DISTRO, proudly tout their criminal backgrounds: "Yes, our owners are felons by definition of the law .... Not scared to work, run, and play with the castaways, pariahs, & those left behind."9 This is not mere puffery. 63. Troy Palmer (a CEO and Principal of BEDROCK) and Mark Ciccarello (a Governor of HUSH) were previously indicted and convicted on federal charges arising from the manufacture of synthetic "Spice", and laundering money from nationwide Spice sales.lo 64. Douglas Campbell (a member of BEDROCK, and President and Manager of DRIP DROP DISTRO), is believed to have plead guilty to federal charges in Idaho involving his possession of a firearm and ammunition as a prohibited person." 65. The HUSH DEFENDANTS rely on undercapitalized shell entities and fictitious business names in order to avoid responsibility for deaths and harms caused by kratom. 66. The HUSH DEFENDANTS have not procured liability insurance to cover the risk of wrongful death or other injury caused by their dangerous kratom operations. 67. Idaho is the home base for MIT THERAPY and DURITY (the "MIT THERAPY DEFENDANTS") 'Drip Drop Distro - Behind the Scenes, HEADQUEST MAGAZINE (February 1, 2023) (httWs://www headguest.com/drip-drop-distro/). 10 PRESS RELEASE: Boise Man Pleads Guilty To Conspiracy In Treasure Valley "Spice" Case, US ATTORNEY'S OFFICE, DISTRICT OF IDAHO (February 10, 2014) (ho2s://www.justice.14ov/usao-id/12r/boise-man-pleads-guilty conspiracy -treasure -valley -spice -case). " PRESS RELEASE: Meridian Man Pleads Guilty To Gun Crime, US ATTORNEY'S OFFICE, DISTRICT OF IDAHO (January 28, 2013) (https://www.justice.gov/usao-id/pr/meridian-man-pleads-guilty-gun-crime). AMENDED COMPLAINT - 15 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 68. According to MIT THERAPY's social media account, DURITY DISTRIBUTION is "the 0 N L Y distributor of Mit Therapy" kratom. 69. The MIT THERAPY DEFENDANTS arrange for their kratom to be tested by Sante Laboratories, in Austin, Texas. The Certificates of Analysis for MIT THERAPY kratom identify the "Customer" as DURITY DISTRIBUTION, in Boise Idaho. 70. These MIT THERAPY DEFENDANTS are able to manufacture over 1,500,000 gelatin capsules of kratom each day, using a state-of-the-art facility with the ability to generate "powder enhanced extract". 71. In addition to their own branded products, the MIT THERAPY DEFENDANTS offer unbranded bulk kratom products for local retailers to sell directly to consumers, without labels or warnings of any kind. 72. The MIT THERAPY DEFENDANTS represent that their "therapeutic" Kratom products were "GMP Certified", safe for human consumption, and effective for controlling pain and anxiety. 73. Through its home page, MIT THERAPY publishes statements from alleged consumers who tout the safe and efficacious use of kratom for medical purposes, including: "Mit Therapy works the very best for controlling pain and the anxiety that accompanies it." 74. On the "About Us" page of its website, MIT THERAPY includes a disclaimer indicating that MIT THERAPY is owned and operated by the entities and individuals behind PurKratom: "PurKratom.com and its owners or employees cannot be held responsible for ... any information whatsoever herein provided." 75. On information and belief, the owners and operators of the business known AMENDED COMPLAINT - 16 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 as PurKratom.com share in the liability of MIT THERAPY. 76. The MIT THERAPY DEFENDANTS rely on undercapitalized shell entities and fictitious business names in order to avoid responsibility for deaths and harms caused by kratom. 77. The MIT THERAPY DEFENDANTS have not procured liability insurance to cover the risk of wrongful death or other injury caused by their dangerous kratom operations. 78. CLOUD HOUSE is a local retail store in Woodland, Washington. CLOUD HOUSE purchases and sells a variety of kratom products to Washington consumers in Cowlitz County. 79. Among its line of branded kratom products, CLOUD HOUSE sold the HUSH liquid shots distributed by the HUSH DEFENDANTS. 80. In addition to branded kratom, CLOUD HOUSE purchased and sold the MIT THERAPY bulk kratom products in unmarked plastic bags, direct to Washington consumers. 81. CLOUD HOUSE, like the other Defendants, represented various medicinal benefits from the consumption of the kratom products sold to Jordan. 82. For example, CLOUD HOUSE described red strains of Kratom as "the most popular choice for those who are treating pain" and "having a more sedative effect" and "a stronger euphoric effect". Green is described as tending "to have more pain -relieving properties than the white, but more energetic than the red". Maeng Da (typically green) is described as "Higher on both pain relief and energy with an emphasis on mood lift." AMENDED COMPLAINT - 17 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 83. CLOUD HOUSE described Kratom as from the coffee family, used in herbal medicine, producing "opioid-like effects" with higher doses, as well as reports of increased work capacity, sociability, sexual desire, positive mood, and euphoria. "It's also been known as a means to bring acute and chronic pain relief." 84. CLOUD HOUSE represents to consumers that kratom is not considered addictive. 85. CLOUD HOUSE is an undercapitalized entity. CLOUD HOUSE has not procured liability insurance to cover the risk of wrongful death or other injury caused by their dangerous kratom operations. 86. All the kratom defendants described above have benefitted from the work of the American Kratom Association ("AKA"), a trade industry group that has fostered the narrative that kratom is appropriate for over-the-counter sale for human consumption, while disregarding the industry standard of safety first. 87. The AKA works with and receives direct funding from a broad range of kratom sellers across the nation, including Defendants in this case. 88. The AKA promotes the distribution and sale of its members' kratom products much like Big Tobacco and Big Pharma. The AKA does so through paid lobbyists, industry - funded researchers who are associated with the tobacco industry, mis-information campaigns promoting kratom as safe and efficacious. 89. The AKA also promotes several kratom brands as certified under a so-called Good Manufacturing Practices ("GMP") Validation program. This GMP program purports to replicate federal industry standards for legitimate products. This GMP program AMENDED COMPLAINT - 18 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 misleadingly certifies that certain kratom "vendors" (and kratom brands disguised as "vendors") have objectively met or exceeded "high" industry standards in manufacturing and bringing their kratom products to market. The AKA claims that the GMP certification will "further enhance the safety of kratom-containing products", with labeling that "provides all the information required for consumers to make an informed purchasing decision." 90. The AKA is also able to rally thousands of kratom advocates who value and depend upon easy over-the-counter access to their opiate -like kratom products. Those who question the AKA's mission are frequently called out and subject to ridicule and disparagement through a variety of channels, including Youtube and social media. 91. The AKA's lead lobbyist is C. McClain "Mac" Haddow. The Tampa Bay Times asked Mr. Haddow about the need to address the risk of death from kratom. Mr. Haddow had this to say about the AKA's position on those killed by the profitable kratom products: "Can we regulate stupid? I can't do that - no one can."12 92. The AKA works very closely with the principals behind the kratom brands that it certifies, including the WHOLE HERBS DEFENDANTS. 93. The AKA promotes the WHOLE HERBS brand at the top of its list of "KRATOM CONSUMER CHAMPIONS" and "PLATINUM VENDORS".13 This honor is shared with other brands associated with the JOPEN-OLISTICA enterprise, including OPMS and Remarkable is Kirby Wilson and Sam Ogozalek, DEADLY DOSE PART 2: As dangerous kratom products go unregulated, lobbyists write the laws, TAMPA BAY TIMES (December 13, 2023) (htips://project.tatnpabay.com/investigations/deadly-dose/american-kratom-association-lobbyists-fda-florida/). 13 https://www.americankratom.org_/ (last accessed January 12, 2024). AMENDED COMPLAINT - 19 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Herbs. 94. The following kratom brands associated with the OLISTICA enterprise are prominently promoted at the top of AKA's list of "AKA GMP Qualified" Vendors: WHOLE HERBS, OPMS, and Remarkable Herbs.14 95. The AKA is familiar with and actively works to support the evasive and clandestine practices of the individuals and entities behind WHOLE HERBS. 96. On information and belief, the WHOLE HERBS DEFENDANTS are founding members of the AKA and created the AKA as a kratom marketing arm while concealing the identities of those who are actually responsible for its business operations, owners, and managers. 97. The AKA holds its certified brands out to the public as, reputable, merchantable, unadulterated, and legitimate for over-the-counter consumption. 98. While doing so, the AKA conceals the identities of owners and operators behind several brands, including the WHOLE HERBS brand. The AKA is obedient to and complicit with the efforts of the WHOLE HERBS DEFENDANTS to avoid accountability to the law, and accountability for those Washington consumers who are harmed or killed by their kratom products. 99. The WHOLE HERBS DEFENDANTS provide substantial funding and other support to the AKA. The WHOLE HERBS DEFENDANTS work closely with the AKA to protect their over-the-counter kratom distribution activities. 100. On information and belief, the WHOLE HERBS DEFENDANTS are involved in 14 https://www.americankratom.org/amp-qualified-vendors (last accessed January 12, 2024). AMENDED COMPLAINT - 20 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the packaging and distribution of all three of these sister brands, under the umbrella of the OLISTICA enterprise. 101. While hiding behind their corporate charades, the WHOLE HERBS DEFENDANTS use the AKA as a marketing and advocacy arm to preserve and promote its wrongful distribution of the WHOLE HERBS kratom product lines, while lobbying federal officials for support in their effort to dominate the kratom industry. 102. For example, the AKA hosted meetings between the WHOLE HERBS Defendant OLISTICA and Geoffrey Laredo, a former official from the National Institute of Health ("NIH"). OLISTICA paid Mr. Laredo to pursue federal funding from NIH for the development of pure kratom for scientific research. 103. The HUSH Defendants also support and work with the AKA, and paid for the AKA's GMP Validation status for the HUSH Kratom brands. 104. With support from the kratom selling Defendants, the AKA has engaged in a targeted effort to legitimize the kratom industry and promote a false sense of safety and merchantability for kratom. The AKA does so by: a. Engaging in a campaign to smear the FDA's credibility regarding safety. For instance, the AKA has stated that the FDA is "gaslighting of the public"15 by asserting that kratom is dangerous. The AKA also blames the FDA for a failure to regulate kratom,16 yet also claims that the FDA exceeds its authority when 15 See https://assets-global.website- files.com/61858fcfc6543059fD6l7522/657386faba36bc4fb9241847 AKA%20Response%20to%2OTampa%2OBay %20Times%2OArticle%2ODec%208%202023.pdf (last accessed December 21, 2023). 16 https://assets-global.website- files.com/61858fcfc6543059fO6l7522/64c7b2a6Oecf41853aa6Oa2l AKA%20Release%207.3l.pdf (last accessed December 21, 2023). AMENDED COMPLAINT - 21 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 taking any action to regulate kratom.17 b. Providing guidance to industry actors, including defendants, regarding marketing and labeling of kratom. For instance, the AKA advised kratom industry actors and to avoid medical claims on packaging, while many defendants continue to promote and/or sell kratom for medical purposes.18 C. Using its authority as the kratom industry trade association to spread a fog of misleading information to persuade consumers that over-the-counter kratom is merchantable, safe, and appropriate for human consumption. AKA guidance and talking points is pervasive on the internet and anyone who searches for information on kratom for the first time is likely to come across the AKA's pro-kratom propaganda. d. Undermining any information revealing kratom's dangerous propensity, including independent research published in peer reviewed medical journals.19 e. Engaging in a nationwide campaign to pass the Kratom Consumer Protection Act ("KCPA") in U.S. States and now at the federal level, purporting to protect a non-existent right to sell over-the-counter kratom as "safe" and "unadulterated" for human consumption, while knowing full well that no " https://www.americankratom.or /ne ews/press-release-fda-creates-an-unauthorized-pocket-ban-authority (last accessed December 21, 2023). 18 https://assets-14lobal.website- files.com/61858fcfc6543059fD6l7522/6568c229145d4a260a3a4048 AKA%20Kratom%20Guidelines%20Nov%20 30%202023%20Final.pdf (last accessed December 21, 2023). 19 https://www.americankratom.org/news/op-ed-kratom-misinformation-in-medical-journals (last accessed December 21, 2023). AMENDED COMPLAINT - 22 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 kratom product has ever satisfied the required showing of premarket safety necessary to make it unadulterated.20 f. Creating a "Good Manufacturing Practice" ("GMP") program to provide a seal of safety and legitimacy for approved manufacturers including Whole Herbs and Hush.21 g. Creating a false sense of safety for consumers who are misled to believe that AKA GMP approved kratom is safe, merchantable, and unadulterated. 105. The AKA's promotion of kratom is so pervasive that consumers routinely and regularly come across and rely upon on the AKA's guidance, misrepresentations, and omissions regarding the regulatory, medical and scientific status of over-the-counter kratom. 106. Jordan McKibban is one of many Washington residents who was exposed to and relied upon the AKA's pervasive messaging about over-the-counter kratom. 107. Jordan McKibban resided in Kalama, Cowlitz County, WA. He was beloved by his family and friends. He was a loyal and successful employee with United Natural Foods, Inc. (UNFI), where he worked in the shipping and receiving industry. 108. At 37-years old, Jordan was healthy, fit, and physically active. He loved spending time outdoors and he was passionate about fishing. He promoted organic and nutritional foods and dietary practices. 109. Occasionally, Jordan experienced work related pain in his hands and back. 20 htips://www.americankratom.org/news/federalkcpa (last accessed December 21, 2023); see also https://www.americankratom.org/news/webinar-on-federal-kcpa (last accessed December 21, 2023). 21 https://www.americankratom.or�z/gmp-standards-program (last accessed December 21, 2023). AMENDED COMPLAINT - 23 mctlaw 1325 4tn Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 110. In his search for a natural pain reliever, Jordan McKibban learned about and relied on the pervasive statements, misrepresentations, and omissions concerning kratom that were generated by the AKA and the other Defendants in this case. 111. Jordan relied upon the Defendants' express and implied warranties, including the basic warranty that the Kratom products were lawfully imported and distributed, merchantable, and reasonably fit for their intended purposes, including the purpose of human consumption, and for the management of pain and anxiety. 112. Jordan learned that Defendant CLOUD HOUSE, in nearby Woodland, was selling Kratom products. Jordan learned that these products were being sold as safe, legal, and all -natural alternatives to pain medications and other prescriptions. 113. Jordan purchased and consumed the following Kratom products: (1) the WHOLE HERBS capsules; (2) the HUSH liquid shots; and (3) the CLOUD HOUSE bulk powders distributed by the MIT THERAPY Defendants. 114. Jordan's friends and family members observed Jordan's use of these products, as well as associated packaging in his home and vehicle. 115. These kratom products all contributed to Jordan's gradually increasing tolerance, dependency, and daily use of the toxic kratom products. 116. On April 5, 2022, Jordan McKibban's kratom use came to an end. A short time after Jordan had arrived home from work, his young nephew A.R. heard a loud noise from the bathroom. A.R. went to investigate, but could not open the door. He began calling family members for help to investigate the situation. 117. Jordan's mother rushed to the home. She was able to force the door open. AMENDED COMPLAINT - 24 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 She found Jordan collapsed on the floor and unresponsive. She called 911, and worked to revive her son. 118. A short time later, emergency responders arrived. They took over efforts to revive Jordan, and rushed Jordan to the hospital with concerns of a possible overdose. 119. It was there, at the hospital, where the family learned that Jordan did not make it. He was 37-years-old. 120. Back at the home, an open bag of bulk kratom powder from CLOUD HOUSE from the MIT THERAPY DEFENDANTS sat on the kitchen counter, where Jordan had mixed his last drink. In Jordan's car and bedroom, family members found empty bottles of the HUSH liquid shot. Those close to Jordan had previously seen him with the distinctive WHOLE HERBS kratom product. 121. The Cowlitz County Coroner's office investigated the cause and manner of Jordan McKibban's death. An autopsy was performed by forensic pathologist Dr. Clifford Nelson, and a postmortem expanded forensic toxicology test was requested from NMS Labs. 122. On May 26, 2022, NMS Labs issued its Toxicology Report. The Toxicology Report showed a positive finding for Mitragynine (the main Kratom alkaloid), in the amount of 3,000 ng/mL. 123. A copy of the NMS Labs report was hand delivered to Dr. Nelson, to aid in the completion of the autopsy report and issuance of the death certificate. 124. Based on the report, and with the guidance of forensic pathologist Dr. Clifford Nelson, the Cowlitz County Coroner issued its case report and cause of death: JORDAN AMENDED COMPLAINT - 25 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 McKIBBAN died from the "Toxic Effects of Mitragynine (Kratom)". VI. CAUSES OF ACTION AND DAMAGES 125. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 126. JORDAN MCKIBBAN suffered an untimely death as a direct and proximate result of the products that were imported, manufactured, marketed, distributed and/or sold by each of the Defendants. 127. The Defendants in this case all failed to warn JORDAN MCKIBBAN that Kratom is: (a) fraudulently imported; (b) wrongfully distributed, marketed and sold for human consumption without the required premarket verification of safety; (c) causing dependence, addiction, and withdrawal in regular users; (d) found to be 63 times more deadly than other natural products; and (e) found to be a contributor or cause of numerous overdoses and deaths. 128. Each and every Defendant wrongfully contributed to JORDAN MCKIBBAN's escalating cycle of Kratom tolerance, dependance and use, which led predictably to the toxic levels that ultimately caused his death. 129. The ESTATE OF JORDAN MCKIBBAN and its beneficiaries have incurred and will continue to incur enormous general and special damages in an amount to be determined by the jury at the close of trial. 130. All kratom imported by a Defendant in this case was manufactured by persons who are not subject to service of process or the jurisdiction of this Court. 131. The WHOLE HERBS, HUSH, MIT THERAPY, and CLOUD HOUSE DEFENDANTS AMENDED COMPLAINT - 26 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 were sellers and/or manufacturers of kratom products under Chapter 7.72 RCW, and are jointly and severally liable for the damages caused to the ESTATE OF JORDAN MCKIBBAN and its beneficiaries. COUNT ONE— FAILURE TO WARN — WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 7.72.010(4) and .030(1)] 132. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 133. Each named Defendant was involved in the promotion, distribution, and sale of the Kratom product that killed JORDAN MCKIBBAN. 134. The Defendants' Kratom products were continuously sold without adequate warnings or instructions regarding the serious health risks of the product, including the risks of abuse, dependence, addiction, overdose, and death. 135. An ordinary consumer would reasonably conclude that Defendants' kratom products are not reasonably safe when sold without warnings or instructions about the serious adverse health risks, including the risk of overdose and death suffered by JORDAN MCKIBBAN. 136. In addition, at the time of manufacture, the likelihood that Defendants' kratom products would cause and contribute to the serious harms inflicted on JORDAN MCKIBBAN (including increasing toxicity and death) rendered Defendants' Kratom warnings and instructions completely inadequate, even though warnings about the poisonous nature of kratom and the risk of those serious harms could easily have been provided. AMENDED COMPLAINT - 27 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 137. At the times and on the occasions in question, JORDAN MCKIBBAN was using the Defendants' Kratom products for the very purposes intended and promoted by the Defendants, including: (a) human consumption of a natural, merchantable over-the- counter product; (b) relief from pain; and (c) relaxation and relief from anxiety. 138. Without proper warnings and instructions, the products were unreasonably dangerous, unfit for their intended use, and defective. 139. If the products had been sold with appropriate warnings and instructions regarding its poisonous nature and the health risks, including but not limited to adequate disclosure of the major risks of overdose and death, then JORDAN MCKIBBAN's overdose and death from the product would not have occurred. 140. The Defendants are liable for all damages caused by their failures to provide adequate warnings and instructions that would have prevented the death caused by their defective and unreasonably dangerous nature of their product. The manufacturer defendants are subject to strict liability for these damages. 141. The Defendants also had a continuing, post -sale duty to warn regarding the unreasonable risk of harm associated with the product after the product had been distributed to JORDAN MCKIBBAN. 142. After JORDAN MCKIBBAN began purchasing and ingesting the products, Defendants knew or should have known of the increasing scientific and medical information confirming the serious risks and dangers associated with their adulterated product, including the risk of death from a powerful substance that was never fit for medically unsupervised use. AMENDED COMPLAINT - 28 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 143. After JORDAN MCKIBBAN, began purchasing and ingesting the product, Defendants all breached their duty to issue adequate post -sale instructions and warnings to reduce and prevent the foreseeable risk of harm and death to JORDAN MCKIBBAN from the products. 144. All Defendants failed to exercise reasonable care to provide adequate post - sale instructions and warnings to JORDAN MCKIBBAN and other Washington residents about the serious health risks and dangers of the product, including the risk and danger of death. 145. As a direct and proximate result of the lack of reasonable and adequate post - sale instructions or warnings regarding the defects in Kratom, Plaintiffs suffered the injuries described above. COUNT TWO — DESIGN AND MANUFACTURING DEFECT WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 7.72.010(2), (4), and .030] 146. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 147. At the time Defendants imported or manufactured the products sold to and consumed by JORDAN MCKIBBAN, the products were not reasonably safe as designed. 148. The Kratom products were and are far more dangerous than the ordinary consumer would reasonably expect, considering relevant factors, such as the product's intrinsic nature, relative cost, severity of potential harm (including death), the industry standards governing natural products, and the cost and feasibility of minimizing such risk. 149. The Defendants are unable to adequately assure that the manufacturing AMENDED COMPLAINT - 29 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 processes for their Kratom products can achieve a product that is reasonably safe for human consumption. 150. The products sold to JORDAN MCKIBBAN was unreasonably dangerous beyond the expectations of the ordinary consumer and was unfit for its intended use. 151. At the time and on the occasions in question, JORDAN MCKIBBAN was using the Defendants' products for the foreseeable purposes that Defendants knew of and intended, and was in this respect defective, unsafe and unreasonably dangerous. 152. As a direct and proximate result of the defects in the Defendants products, Plaintiffs suffered the injuries as described above. COUNT THREE — BREACH OF WARRANTY WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 7.72.010(4), .030(2)(b) and .040(1)] 153. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 154. Defendants all expressly and impliedly warranted that their products were reasonably fit for their intended purposes of human consumption, improving health and well-being, and as a safe and effective product for medical purposes such as pain relief and anxiety. 155. Defendants issued these warranties to develop and promote the sale of their products through their respective chains of distribution and retailing, ultimately resulting in the sales to JORDAN MCKIBBAN. 156. As a Washington resident and employee, JORDAN MCKIBBAN was a reasonably foreseeable end user of the product, and was a third -party beneficiary of all AMENDED COMPLAINT - 30 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 warranties made and passed along by the Defendants through the chain of distribution to the end users. 157. The Defendants' warranties regarding product related to material facts regarding the safety and efficacy of Kratom. 158. The Defendants' warranties, including the warranties that the products were merchantable and lawfully on the shelf, safe, and would not kill you, were part of the basis of the bargain for JORDAN MCKIBBAN's purchases of the products. 159. The Defendants' warranties were untrue; the Defendants' products did not conform to the representations that were made. 160. Asa direct and proximate result of the breach of the Defendants' warranties regarding the products, Plaintiff suffered the injuries and death described above. COUNT FOUR — MISREPRESENTATION WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 7.72.010(4) and .040(1)] 161. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 162. As stated above, Defendants made misrepresentations of material facts about the Kratom product and intentionally concealed information about the product from Plaintiffs during the time JORDAN MCKIBBAN bought and used the product. 163. Defendants possessed superior knowledge about the lack of clinical testing and safety of its products, including the lack of reliable support for representations about the asserted clinical and medicinal safety of the product, and the absence of deaths caused by kratom products. AMENDED COMPLAINT - 31 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 164. Defendants failed in their duty to disclose known material facts to Plaintiffs regarding their products, including but not limited to: a. The health risks (including deaths) associated with regular consumption of kratom products. b. Information regarding adverse events associated with kratom products. c. The risk of overdose and death associated with kratom products. 165. Additional misrepresentations and concealment included, but were not limited to: a. Falsely representing that the product will not cause death. b. Falsely representing that the product is safe and appropriate for regular human consumption. c. Falsely representing that every batch of Kratom product was lab tested for quality and purity. d. Falsely representing that the product is never adulterated. e. Falsely representing that the product has no serious adverse health effects. f. Falsely representing that an AKA GMP certification assured the consumer of a product that had satisfied the standards necessary to be safe and ready to be sold off the shelf for human consumption 166. The foregoing representations and omissions were material and were made with the intent to persuade and induce JORDAN MCKIBBAN to choose and regularly use the product. 167. Defendants made the above representations or omissions knowing the misrepresentations were false or were ignorant of the truth of the assertions. 168. The above representations and omissions are reflected in Defendants system for marketing its product. Together, all these defendants unlawfully promoted and held out for sale the unreasonably dangerous product for medicinal purposes to Washington Residents. AMENDED COMPLAINT - 32 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 169. Defendants made the above misrepresentations or omissions with the intention and knowledge that Washington consumers would select the product for regular consumption for the purposes identified in their marketing. 170. JORDAN MCKIBBAN relied upon and was induced to act in reliance on these Defendants' misrepresentations and omissions when he in fact purchased the product to achieve relief from chronic pain. 171. As a direct and proximate result of the breach of the warranties regarding the product, Plaintiffs suffered injuries as described above. COUNT FIVE — NEGLIGENCE WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 7.72.010(4) and .040(1)] 172. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 173. The Defendants were all negligent and careless in the import, design, manufacture, testing, marketing, distribution, and/or sale of Kratom products. 174. The Defendants, as product sellers, were negligent and careless in their distribution, promotion and sale of Defendants' Kratom products. 175. The Defendants failed to follow the industry standard of safety first, which exists for the protection of consumers from New Dietary Ingredients whose safety and efficacy has not been established. 176. The Defendants failed to follow the industry standards which prohibit the use of medical claims in the marketing, distribution, and sale of botanical ingredients for human consumption. AMENDED COMPLAINT - 33 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 177. The Defendants failed to follow the industry standards which require the disclosure of material facts necessary to prevent consumers from being misled about the relative safety or danger of the products that are proposed for their consumption. 178. The Defendants knew or should have known that the improperly imported Kratom products were unreasonably dangerous for human consumption and especially for medical uses including but not limited to the alleviation of chronic pain. 179. The Defendants knew that they were unlawfully selling the products to customers for medical purposes, even though the unreasonable health risks of such use were not properly understood, identified, disclosed, approved or regulated. 180. Defendants' failures to discharge their duties were a direct and proximate cause of Plaintiffs' injuries as described above. COUNT SIX — UNFAIR TRADE PRACTICES WHOLE HERBS, HUSH, MIT THERAPY, AND CLOUD HOUSE DEFENDANTS [Wash. Rev. Code Section 19.86.010] 181. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 182. The acts by Defendants in this cause of action include, but are not limited to, the following deceptive and unfair acts: a. Representing that kratom is merchantable and safe for human consumption as a natural over-the-counter product. b. Failing to disclose adequate information about the safety and efficacy of the Kratom product, either before or after Plaintiffs' purchase. c. Failing to provide adequate warnings, labels or instructions about the AMENDED COMPLAINT - 34 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 product's dangerous propensities. d. Knowingly selling the product for human consumption and the alleviation of chronic pain, despite sham reseller conditions that the product should only be sold for "research", "incense", "ornamental" or similar purposes that do not involve human consumption. e. Representing that the product is appropriately used for medicinal benefits. f. Representing that the product possesses many therapeutic effects. 183. Such acts occurred in the course of trade or commerce in the State of Washington. 184. Such acts affected, and still affect, the public interest of all the citizens of the State of Washington. 185. Such acts caused injury to JORDAN MCKIBBAN in his property and business, by forcing him to incur substantial expenditures on a product that instead of being safe and effective, was the cause of his death. COUNT SEVEN —INFORMATION NEGLIGENTLY SUPPLIED FOR THE GUIDANCE OF OTHERS -- AKA [Restatement of Torts, Section 5521 186. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 187. The AKA supplied information for the guidance of Washington consumers, including decedent, JORDAN McKIBBAN, in their business transactions that were false. 188. The AKA knew or should have known that the information was supplied to guide Washington consumers, including the decedent, in their business transactions, AMENDED COMPLAINT - 35 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 namely purchase of kratom products. 189. The AKA was negligent in obtaining or communicating the false information, including but not limited to: a. Claiming kratom was safe, particularly if purchased by a GMP certified vendor. b. Actively campaigning against warnings, enforcement action, and medical literature from trusted actors including the FDA and medical journals that call Kratom's safety and efficacy into question. C. Actively campaigning to legitimize kratom through passage of the so- called Kratom Consumer Protection Act. 190. JORDAN McKIBBAN relied on said false information, and such reliance was reasonable. 191. The false information proximately caused the death of JORDAN McKIBBAN. 192. Further, the AKA had a duty to disclose to JORDAN McKIBBAN the following information including but not limited to: a. The risks associated to use of kratom, including addiction and overdose. b. The truth that GMP certification does not amount to safety. C. The truth that even GMP certified labeling is both non -compliant with FDA requirements but is wholly deficient for provision of a safe product. 193. The AKA did not disclose this information to JORDAN McKIBBAN. AMENDED COMPLAINT - 36 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 194. The AKA was negligent in failing to disclose this information. 195. Such disclosure would have caused JORDAN McKIBBAN to act differently, and JORDAN McKIBBAN was damaged by the failure to disclose such information. COUNT EIGHT —NEGLIGENCE — AKA and WHOLE HERBS DEFENDANTS [Restatement of Torts Section 324A] 196. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 197. The AKA and WHOLE HERBS DEFENDANTS were negligent and careless in their actions described herein, including their coordination and orchestration on a campaign of misrepresentations made to the public and consumers regarding kratom's safety for human consumption; attacks on legitimate science examining Kratom's safety profile; attacks on kratom regulation including actions taken by the FDA; guidance and advice provided to kratom manufacturers, distributors, and sellers; and the administration of their GMP certification program. 198. The AKA and WHOLE HERBS DEFENDANTS knew or should have known that improperly imported Kratom products were unreasonably dangerous for human consumption and especially for medical uses including but not limited to the alleviation of chronic pain. 199. The AKA and WHOLE HERBS DEFENDANTS knew or should have known that their campaign to foster a market and create a sense of safety surrounding the use of kratom was negligent insofar as the activities promote the unlawful sale of kratom products to customers for medical purposes, even though the unreasonable health risks of such use AMENDED COMPLAINT - 37 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 were not properly understood, identified, disclosed, approved, or regulated. 200. The AKA and WHOLE HERBS DEFENDANTS assumed a duty in relation to kratom sales because they exert significant control over the kratom industry and other members of the trade association through administration of the GMP certification program, its funding structure, and its predominance over the public discourse over kratom importation, manufacture, sale, and use. The AKA and WHOLE HERBS DEFENDANTS have also assumed a duty because of their denial of known risks of kratom; their active role in advocating for kratom's importation, manufacture, and sale; and their active role in creating a market in which kratom is falsely viewed as safe by many consumers. 201. The AKA's failures to discharge their duties were a direct and proximate cause of Plaintiffs' injuries as described above. COUNT NINE — CIVIL CONSPIRACY AKA, WHOLE HERBS, HUSH, MIT THERAPY DEFENDANTS [Restatement of Torts Section 876] 202. Plaintiffs re -allege and incorporate by reference the paragraphs above as if fully stated herein. 203. The AKA, WHOLE HERBS DEFENDANTS, HUSH DEFENDANTS, and MIT THERAPY DEFENDANTS combined to accomplish an unlawful purpose, including the importation, marketing, distribution, and sale of kratom within the United States and Washington. 204. The AKA, WHOLE HERBS DEFENDANTS, HUSH DEFENDANTS, and MIT THERAPY DEFENDANTS, entered into an agreement to accomplish the object of the conspiracy including by creating, supporting and/or participating in the AKA's "Good AMENDED COMPLAINT - 38 mctlaw 1325 4" Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Manufacturing Program"; and by funding the AKA to engage in the actions described above and incorporated herein. 205. The AKA and WHOLE HERBS DEFENDANTS (particulary the OLISTICA enterprise), 206. Such civil conspiracy was a direct and proximate cause of Plaintiffs' injuries as described above. VII. PRAYER FOR RELIEF AND DEMAND FOR JURY TRIAL WHEREFORE, the ESTATE OF JORDAN MCKIBBAN, by and through and on behalf of all its beneficiaries, respectfully requests a jury be impaneled to hear this case, and for judgment against the Defendants: (a) Awarding general and special damages in an amount to be proven at trial; (b) Awarding injunctive relief pursuant to Chapter 19.86 RCW; (c). Awarding reasonable attorney's fees and costs, including attorney's fees pursuant to Chapter 19.86 RCW; (d) Awarding punitive damages to the full extent allowed by Chapter 19.86 RCW; (e) Awarding such other relief as the Court deems just and proper under the circumstances of this case. DATED this 12th day of January, 2024. ATTORNEYS FOR PLAINTIFFS Talis M. Abolins WSBA No. 21222 Michael J. Cowgill WSBA No. 55303 mctlaw AMENDED COMPLAINT - 39 mctlaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1325 411 Ave. # 1730 Seattle, WA 98101 Phone: (206) 487-7371 Email: tabolinsgmctlawyers.com Email: mcow i�llgmctlawyers.com AMENDED COMPLAINT - 40 mcdaw 1325 4th Avenue, Ste 1730 Seattle, WA 98101 Phone: (206) 487-7371 Kratom's Risk of Death Deaths from Deaths from Kratom are 63 times greater Natural Products than deaths from other Natural Products AV NI _ ST. JOHN'S WORT I EGHINEA I I I I GINSENG KRATOM 40 Source: Li, et al., An evaluation of adverse drug reactions and outcomes attributed to kratom in the US FDA Adverse Event Reporting System from January 2004 through September 2021 (Clinical and Translational Science, 2023) PLAINTIFF 147 Arrhythmia/CardiacIL Ventricular / / / FDA O S = 4 Increased risk °�. 2 as c� 0 LM °a 0.5 0 a Lea aZ �aIl Source: Krantz, et al., VentricularArrhythmias Associated with Over -the -Counter and Recreational Opioids (Journal of the American College of Cardiology, 2023) PLAINTIFF 152 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Chris P <chrispulido44@gmail.com> Sent: March 08, 2024 10:47 PM To: City Clerk's Office Cc: Dept - City Council Subject: Ordinance No. 2024-5 To whom it may concern, I do not support Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code. I believe banning kratom will cause unneeded suffering to those who use it. Kratom has been used safely for thousands of years in several countries and cultures. While there have been incidents involving kratom recently occurring, these are isolated incidents and usually involving extracts which are not the natural, typical, or recommended way of consumption. These extracts are often unregulated and similar to taking high proof alcohol such as everclear. However I believe a majority of users do not use extracts. Well-informed users know to research companies who comply with third party testing and verifiable sourcing. Kratom has also been used to assist in deadly and dangerous withdrawals from opioids. We currently face an opioid epidemic in the country, and to remove a useful tool in addicts recovering from withdrawals would cause undue harm and suffering. It has also shown promise in people recovering from other substances. I myself have had troubles with nicotine and alcohol, and have found kratom extremely beneficial in relieving and reducing cravings. My doctor is aware of and approves of my kratom usage. I do believe that kratom should be federally regulated similarly as other supplements by the FDA, and I believe that showing your support for such a cause, as opposed to outright banning, would be the right course of action. I bid you to please consider mine and others experiences and stories, and to consider how it might be used. An age restriction may be a compromise. This would keep it out of minors' possession. Thank you for your time, Christian Pulido Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Teresa Bobbe To: City Clerk"s Office Subject: Re: Ordinance 2024-5 Date: March 09, 2024 5:21:30 AM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the Efe. AN Hi my name is Teresa and I wanted you guys all to know how much kratom has helped me personally and several others that I know. First off I was diagnosed with severe spinal stenosis and degenerative disc disease and bulging disc's of the lower spin in 2019 I was put of opioid pain medication to control the pain.. I knew how horrible those drugs are and I was always into more of a Holistic approach.. I did some research for quite sometime and came across the wonderful plant mitragyna speciousa aka kratom. I heavily researched its history and spoke to others who's lives it saved.. I finally gave it a try and never looked back. I got off of the terrible opioids and found that kratom bot only helps me with severe chronic pain..but it helps control my anxiety and depression and gives me my life back to be able to play with my kids again and live a much more productive life. I truly find it soo sad that the misinformation regarding kratom has led others to believe this wonderful plant could be harmful. It never once has impaired my thinking or motor skills in any way shape or form.. it's saved so many from alcohol addiction and other very destructive substances. I call kratom a gift from God. It truly is such an amazing plant with many other health benefits such as anti-inflammatory, immune boosting properties and so many more.. Please reconsider this possible ban. It truly truly is a miracle for s000 many people I do not support Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code God Bless! Teresa Elizabeth 951.422.4371 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Keith Sutter To: DDe t - City Council Cc: City Clerk"s Office Subject: Kratom ban Date: March 09, 2024 10:01:13 AM ERNAL WAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the is safe. I am a 100% disabled veteran and i rely on kratom for pain relief instead of taking prescription hydrocodone. I dont live in Newport but i know that things like this spread to other citities. Please consider how this will affect the responsible citizens. I do not support Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Marc Perdue To: City Clerk"s Office Subject: Kratom saved my life - please read! Date: March 09, 2024 10:05:26 AM Attachments: Kratm Advocate.odf Kratom FactvsFiction FINAL.odf [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the ,ontent is safe. To whom it may concern: My name is Marc and I am a 33 year old male. My experience with Kratom and its legality is the focus of this letter. I have had a long and treacherous battle with substance abuse. I have had multiple recurring bone tumors on the medial side of my tibia below my knee. The diagnosis and subsequent surgeries started at the age of 14. I have had six major surgeries on my right leg. Three of which were for tumor removal and the other three for MRSA treatment and debridement. My knee is completely damaged from the tumor destroying the top of my tibia and the MRSA completely eating away at my meniscus and cartilage. I have severe chronic and acute pain in that leg because of this. I am not a candidate for a knee replacement due to the bone being too damaged and not a stable site for the new artificial joint. I have also been in a severe car accident that lacerated my left arm, broke the fibula in my left leg, and tore the meniscus in my left knee. The treatment of these ailments came with a lot of prescribed narcotic pain medications on a regular basis from age 14 on. My tolerance to these medications started to grow astronomically over 15 years and they stopped working effectively. I eventually was buying OxyContin on the street and abusing them heavily. This eventually led to IV heroin and cocaine use and the loss of anything of real value I had. I struggled with this crippling addiction for 18 years. I tried methadone, Suboxone, Vivitrol, complete abstinence and had NO significant success with any of them. Finally, I found that a strong 12 step recovery was what I needed, and it would work temporarily but the physical pain I suffer from would become too much and I would relapse on opiates. 5 1/2 years ago, I found kratom and decided to try it for pain relief. It helps me with pain, it helps me sleep, curbs craving, allows me to function and participate in activities of daily living without being in extreme pain. I do not have extreme tolerance building problems with kratom like I did with traditional opioids. The side effects are extremely minor and do not impair my judgment or ability to function. I am up at 4:30 AM every day and at the gym by 4:45 cycling for an hour. I have lost weight in a healthy fashion due to my exercise and diet change that kratom has helped me make. I am much more positive about taking care of myself and am able to be present for life. My pain hasn't completely vanished, but it is manageable due to kratom. I am the healthiest and happiest I have ever been in my entire life! My spiritual growth has been a big factor as well in my 12 months of sobriety along with kratom. I have found that these two things working in harmony have literally saved my life! I am a completely different person, and my family has their son back. I do not want to die and the fact that this harmless plant is being targeted makes me scared for my life. Let's focus on alternative rehabilitation and recovery methods. Let's focus on the fentany and other analogues specifically ... NOT A NATURAL BOTANICAL! Please ... let's take a step back here and look at the success stories and reanalyze things. Making this plant illegal will immediately criminalize innocent Americans that will suffer if kratom is taken away. The war on drugs has been a failure and taking away such a helpful tool people use to avoid lethal prescription drugs and heroin/fentanyl will cause even more deaths. People have bad reactions to everything. The number of hospitalizations and deaths from acetaminophen is astronomically higher than deaths supposedly caused by kratom. People are almost always having issues from polysubstance use where kratom is not the only drug in there system. Thank you for taking the time to read this. I hope you show empathy for chronic pain and recovering addicts that use this plant. Let's work with the American Kratom Association on advocating for safe manufacturing practices to ensure adults have access to pure and unadulterated kratom products in the USA. Sincerely, Marc Perdue Email: mj2eredue98550&gmail.com Kratom Story Video for AKA.zi.p 10 Kratom Story Video for AKA.MOV MTUM FAa RCTION VS. More than 2 million Americans safely consume Kratom to improve their health and well-being and have done so for decades. It is regulated by the U.S. Food and Drug Administration (FDA) as a dietary supplement, and KRATOM people who consume Kratom report doing so for the same reasons as people who drink coffee, tea, or other caffeinated beverages. Surveys show that Kratom consumers are educated, middle -income, employed, and TRADE have health insurance. Despite being used responsibly for decades in the United States, there are many ASSOCIATION misconceptions about Kratom, making it difficult to tell fact versus fiction. • • NO FACT: Drugs like heroin, oxycodone, and other "classic" opioids are full opioid Kratorn is an opioid agonists, meaning they fully bind to and activate the brain's receptors. Kratom, on the just like heroin. other hand, is a partial agonist, producing milder effects with lower dependence and abuse potential. Evidence suggests Kratom does not cause respiratory depression like 111106 other opioids, a common cause of fatal overdoses. ICTION:FACT. Schedule I substances are without accepted medical use and have a Kr atom should be A high potential for abuse. Published analyses have shown that Kratom does not meet classified_ the test to be a Schedule I drug and does not fit into the FDA's 2017 abuse potential assessment guidance. Respondents to official surveys from the federal Substance ranking it controlled substance,_r than Abuse and Mental Health Services Administration do not report abusing Kratom or seeking treatment for Kratom dependence, refuting claims from treatment clinics that •caine and Kratom abuse is prevalent. While many independent scientists have said Kratom methamphetamine. holds the potential to address pain, scheduling Kratom will make any further research on the product virtually impossible. FACT. Similar to coffee, tea, and other caffeinated drinks, consumers may become dependent on Kratom with daily use, which is not the same as addiction. Many people need a cup of coffee to wake up in the morning, but we wouldn't saythat they're "addicted" to coffee. "Withdrawal" symptoms of Kratom are comparable to those of caffeine, nicotine smoking cessation aids, or antidepressants. Unlike substances with high abuse potential, increasing the dosage of Kratom does not lead to exponentially stronger euphoriant effects. ICTION:FACT. There are no deaths directly linked to Kratom consumption. Recently Kratom- • • • - published studies found no evidence of deaths linked to Kratom, and for • - than 44 publicly -available data show that nearly all of the recently reported fatalities were deaths according • found to have multiple substances present in their system at the time of death and/or Food , nd �prior health issues. Contrast this with the fact that more than 115 Americans die daily rug from opioid overdoses, according to The National Institute on Drug Abuse, while Administration millions consume Kratom safely and responsibly. FICTION:FACT: Kratom is regulated by the FDA. To provide consumers with safe, The Kratom • high -quality products, the Kratom Trade Association requires its members to adhere has o production to a strict set of principles, sets product testing protocols exceeding Good standards or consumer Manufacturing Practice (GMP) guidelines, and assists manufacturers in obtaining GMP safety protocols. facilities certifications. The organization also supports age restrictions and labeling A/ guidelines outlining responsible use. Sources: Henn ingfield, J. E., Fant, R. V., & Wang, D. W. (2018). The abuse potential of kratom according the 8 factors of the controlled substances act: Implications for regulation and research. Psychopharmacology, 235(2), 573-589. Pinney Associates. (November 28, 2016). Assessment of Kratom Under the CSA Eight Factors and Scheduling Recommendation. Kruegel, A. C., Gassaway, M., Ka poor, A., Varadi, A., Majumdar, S., Filizola, M., Javitch, J., & Sames, D. (2016). Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atyppical Molecular Framework for Opioid Receptor Modulators. Journal ofthe American Chemical Society,138 (21), 6754-6764. Grundmann, O. (2017). Patterns of Kratom use and health impact in the US —Results from an online survey. Drug and Alcohol Dependence,176:63-70. 0 @KratomTrade I KI @TheKratomTradeAssociation I KratomTrade.org Last updated 7/25/18 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: iennifer weatherford To: City Clerk"s Office; Dept - City Council Subject: Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) Date: March 10, 2024 10:10:59 AM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the Efe. To the council members who are deciding on this ordinance I ask that you read my email to you. I am not a resident of New Port Beach but I am a citizen of the United States and wanted to reach out to you. Please do not support this ordinance to ban Kratom. It has helped millions of people get off drugs, manage pain, get free from depression and more. The citizens of your New Port Beach who use this tea responsibly should have the freedom to choose to use kratom and for many many people like me kratom IS life. I implore you to research and look further into the science of this plant. My personal kratom story: After being diagnosed with transverse myelitis in 2005 I became a chronic pain patient. I suffered for 13 years until I found kratom in May of 2019. I have responsibly consumed it for almost 5 years and it's given me a second chance at life! It's helped me more than ANY of the prescription pain meds I've been prescribed over the years.I'm not suffering everyday I can get out of bed and be a better mom! I can go to the store, I can actually live life! I still have things I will never be able to do for the rest of my life because I have Transverse Myelitis but I don't have to live every day of my life in pain anymore. Banning kratom would not only infringe upon my personal freedom to choose how I manage my health but would also negatively impact many others within our community who rely on this herbal supplement for various reasons. It is essential to consider the well-being of all citizens and ensure they have access to safe and effective options for managing their health conditions. Instead of implementing a ban, I encourage the City Council to explore alternative solutions such as education and passing the KCPA which would implement regulations.By establishing guidelines for the safe use of kratom and providing accurate information to the public, we can promote responsible consumption while addressing any concerns about misuse or abuse. In conclusion, I respectfully urge you to consider the voices of kratom consumers like myself and vote against the proposed ordinance to ban kratom. Thank you for your attention to this matter. Sincerely, Jennifer Gillis Get Outlook for Android Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Jaime bastida To: City Clerk"s Office Cc: Dent - City Council Subject: Kratom Date: March 10, 2024 10:49:45 AM [EXTERNAL AIL] DO NOT CLICK links or attachments unless you reco nine the sender and know the content is safe. I don't support the Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: 5 Eppard To: City Clerk"s Office; Dept - City Council Subject: my son died from kratom Date: March 10, 2024 6:22:48 PM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the ife. AN I support Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code. My perfectly healthy 22 year old son Matthew Eller died from using Kratom powder (the least potent form of kratom). Kratom caused him to have a seizure, go into cardiac arrest and die. His autopsy results read: "TOXIC EFFECTS OF MITRAGYNINE" (an alkaloid found only in kratom). His toxicology showed he had no prescription drugs, no street drugs nor alcohol in his system. Because of Matthew's death, I'm in therapy, I have extreme anxiety, depression, insomnia, agoraphobia, my teeth are deteriorating and I look and feel 15 years older than my age. I find very little enjoyment in life, and my days are a horribly long combination of pretending to be okay and wishing I would die and go be with my son. My son's father intentionally crashed his car the day after Matthew died, and because of his injuries he no longer remembers any of our children nor realizes Matthew is dead. My surviving son is completely devastated because he lost his only brother and essentially his father; he also crashed his car on purpose, and later repeatedly smashed his own head into his car. So when you hear only a few hundred people died from Kratom, think of the thousands of lives it has forever destroyed. The Tampa Bay Times did an in depth investigation on Kratom and put out an excellent Documentary called "Deadly Dose" https://project.tampabay.com/investigations/deadly-dose/kratom-industry/. Kratom is remarkably similar to opiates, and shouldn't be sold out of gas stations & smoke shops with unlimited supply to the consumer. Mac Haddow, Lobbyist for the American Kratom Association/AKA admits to profiting from the sales of Kratom, is a self proclaimed Kratom user, and will attempt to dupe you into thinking you have no right to make Kratom illegal. Kratom meets the criteria for being a Schedule I drug as it currently has no accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and has a high potential for abuse. The American Kratom Association has 43 Kratom Sellers on their website: https://www.americankratom.org/gmp- qualified-vendors. Of these 43 Kratom sellers at least 4 of them are involved in kratom wrongful death lawsuits and one of them is involved in a class action lawsuit alleging they hid the fact that kratom is highly addictive. The American Kratom Association who profits from the sale of Kratom suggests, "at a higher serving size it helps people to suppress feelings of depression", causing people to neglect safely monitored treatment resulting in deeper depression, psychosis and sometimes suicide. Mac Haddow also states, "in higher doses people are successfully weening off of opioids", causing addicts to add kratom to the drugs they are already using resulting in liver damage, seizures, cardiac arrest, coma, permanent brain damage and death. Mac Haddow of the AKA deceptively cited kratom deaths from 2016 - 2017 in committee meetings in 2023, leading government officials to believe that kratom has only killed a few people. Some great anecdotal evidence of Kratom being highly addictive and deadly can be found on Reddit: r/quittingkratom - 40K members, Facebook: Quitting Kratom Support - 6K members, Quitting Kratom No Judgement - 2.3K members, and Kratom Danger Awareness with 100's of members whose loved ones died from kratom. You likely heard stories of how people believe kratom has "saved their life", that's because it seems good at first just like heroin or other opiates. Then once addicted, it's needed just to keep from feeling withdrawals, which most ex -users say are horrendous. The other stories you may hear are from those profiting from Kratom who downplay addiction, side effects and deaths from Kratom. They say "it's a plant in the coffee family" however, deadly Hemlock is a plant in the carrot family (that doesn't mean it's safe). They will also say nonsense like "you can die from water" just to deflect and minimize the dangers of Kratom. Kratom effects are liver damage, weight loss, aggression, nausea, vomiting, hair loss, brain damage, anxiety, depression, dizziness, drowsiness, hallucinations, delusions, muscle pain, psychosis, seizures, cardiac arrest, coma and death. Many people state they are using kratom in place of other drugs, but as evidenced by death certificates, emergency room visits, medical examiner findings, poison control center calls; kratom is mostly just being added to drugs people are already taking with the added danger of having an unlimited supply. Baby's born to mothers using kratom often have Neonatal Abstinence Syndrome which cause baby resting tremors, hypertonia, irritability, facial excoriations, screaming and some require an infusion of morphine to stay alive. In 2016, the FDA recommended kratom be criminalized as a Schedule 1 drug, alongside heroin. A California man Sebastian Guthery whose companies grossed more than $60 million selling kratom. was found guilty of money laundering. He was a founding funder of the American Kratom Association (AKA), a non-profit advocacy group that rallied kratom users to beat back the FDA's effort to outlaw kratom, and has since pushed model legislation to fully legalize and lightly regulate the drug which — once snuck through customs — remains legal to sell in 44 states." (courthousenews.com) Testing for kratom post mortem in many cases is by request only, this combined with the fact that many user hide their Kratom use makes it impossible to know the actual number of people dying from Kratom. Attached are photos of my son. Please call or email me if you have any question. Sincerely, Susan Eppard 231-286-4498 switchinz@yahoo.com ir ! ■ v BROTHER, r T. UnmSon & FRIEnD MATTHEW JOSEPH AIP wJ �* �.� r• °0' ELLER F b , MAR. 8, 19 9 9 OVb 10.0 2021 -.., 1 ■ pf _ r f r `1• �•'�r, :;•:�r; r, -•'. Jtir�•� '.;y� . 4rri " +. •` =�. • rLi • 1. �� N►- * •... <ih' 4. r �� i!r _ ' S '1i1 R 1^ �f wwM7 Y F4y � T won "row a•" 00 [ urn 1 Fr RT U DTiiU 51Gri?FCAtiZ CONDMGI%M MW%Wft tCd ` dtiaa In t • WU A MkNwm OF D"TH 4�i- WA; A ~ Accident "� 41ILDAMOfEWURY 4MTDa 1 L Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Stephen C. McIntosh To: Dept - City Council; City Clerk"s Office Subject: Opposition to Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) Date: March 11, 2024 10:07:19 AM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Hello, I am writing to state my opposition to "Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code". Kratom has been incredibly valuable to me. I am permanently disabled and medically retired for heart failure and chronic pain. Like many Americans, I obtain my health insurance though my spouse's workplace, which limits the options I have for insurance and thus treatment (HMO). Unfortunately, my pain medication was stopped against my will after 5 years in 2018--a troubling trend among patients dealing with chronic pain across the United States where medications have been stopped, reduced, (or where they are experiencing shortages), often replaced by ineffective options or nothing at all. After losing this valuable resource, I was able to maintain, and even improve my physical ability because I discovered kratom when my medication was stopped without warning. I have been using kratom for 6 years now and experience fewer side effects and greater physical mobility, including doing the PT that cardiology has recommended. My lab work is as it was prior to beginning kratom. It is much more functional and cost effective than medical cannabis, which I qualify for, but was not terribly effective, not very functional (impairing), and much more expensive --which is a burden for those like myself on a relatively fixed income. Prohibiting sales and distribution within the city will do little, if anything, to stop lawful access. Consumers will still be able to obtain it in nearby cities. All it will do is make obtaining it more burdensome to those who would benefit from it, who have carefully selected vendors based on what has worked for them, what has undergone Good Manufacturing Processes certification, and has a reasonable price. This would affect people like myself who use it for medical purposes to manage a disability, some of whom have limited transportation or who do not/can not take their medications when they drive. This proposal does not serve the public interest, and does not achieve any practical end that would justify it. It is merely punitive and disruptive toward those who have the most to gain by responsible use, and those of limited physical or financial means. No medication, supplement, or health care product is ideal or appropriate for every patient, but in my case and the cases of many others, it has been incredibly valuable for a number of conditions that can be highly disruptive, difficult, and in many cases disabling. Attempting to disrupt adult access is inhumane in cases such as mine. I hope that no member of the council finds themselves in unmanageable pain, but if they do, I hope that this option will minimally be available to them if they choose to use it --especially if their pain is insufficiently treated by their medical provider. Thank you for your consideration, and hopefully compassion toward people like me who have done nothing wrong in utilizing this resource. Stephen McIntosh Stephen C. McIntosh, MBA Software Developer and Associate Instructor of CIS (Ret.) Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: JW Ross To: City Clerk"s Office Subject: Fwd: Kratom Newport Beach Ban Date: March 11, 2024 10:54:14 AM [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the ;ontent is safe. Fyi JW Ross +1-310-905-7886 Botanictonics.com Begin forwarded message: From: JW Ross <jross@botanictonics.com> Date: March 11, 2024 at 10:23:02 AM PDT To: Ikleiman@newportbeachca.gov Cc: citycouncil@newportbeachca.gov, Damarys Colon <dco lon@botanictonics. com> Subject: Kratom Newport Beach Ban Attachments available until Apr 10, 2024 Council Member Kleiman. Good morning Would you have time for a zoom today to discuss ? Thanks JW Ross Founder +1-310-905-7886 botanictonics.com Click to Download Botanic Tonics letter - Newport Beach_031124.pdf 126 KB Click to Download California Kratom Regulation_v1.pdf 83 KB Is] fRI a 11115 , [.fT' Botanic Tonics Press Doc 020324.pdf 20.8 MB Received After Agenda Printed March 12, 2024 Agenda Item No. 3 11 March 2024 Joe Cartwright Chief of Police City of Newport Beach Dear Chief Cartwright, I learned recently about the measure you proposed to the City of Newport Beach to consider a ban on kratom products. As founder of Botanic Tonics which makes kava-forward products which includes kratom, I am concerned. My aim in writing is that you will consider holding off putting forward this measure until you have been briefed by product makers like me. Attached is a backgrounder that has a detailed description of Botanic Tonics. It includes our history, guiding principles, product description and other helpful information. However, I would like to point out one specific graph that I believe makes an important point about the relative safety of kratom (page 18). This graph presents total call numbers for each of multiple substances including kratom. Poison Center Calls per Sub5tance 2017 to 21D2 F :0on1a. 1460CC 12wte ,a9aae ACUUO ■RO! 024TB ■M19 --2U20 1LI; Source! American Asso�-ation of Poison Coop (oi Ceorers 4-�, As you can see, this data is based on U.S. Poison Control Centers between 2017 and 2021 and is organized by substance (see "Calls per Substance"). When normalized by 100,000 users (see "Calls per 100K Users") the trend remains and the point remains in tact. By far, the most deaths concern opioids, followed by alcohol and antidepressants. There were only 15 calls that resulted in death after kratom ingestion, whereas opioid calls that resulted in death were almost 1,500 in the same 5-year period. I believe this graph clearly shows calls regarding kava and kratom barely register (in my opinion, this is low even considering kava and kratom are used far less frequently than these other substances). Together this data and graphs aims to communicate concisely what a growing canon of scientific research shows - concern over kratom products must be considered alongside facts and science. For Botanic Tonics' part, we are committed to a set of principles that puts science, facts and safety first. Our products and marketing are led by science including investments in clinical trials, consultation with leading functional experts and scientists, and world -class Research & Development team. We don't make claims that aren't supported by empirical evidence. Botanic Tonics has an exceptional safety record. Overall, our customers report positive experiences with our products when consumed as recommended, with rare cases of minor adverse events. Since our inception, no verified severe incidents (hospitalizations or deaths) have been reported Most of all, we are dedicated to educating about the relative safety of all our active ingredients. We believe Botanic Tonics provide productivity enhancement and to combat occasional stress and anxiety. Furthermore, in the context of California, AB 2365 was filed on February 12th, 2024. AB 2365 is the strongest Kratom Consumer Protection bill that will be passed by any state. It considers the realities of the kratom marketplace, the latest scientific findings, the distinction between different kratom formulations, and the need for more informed consumption to protect consumers and responsibly maintain access to safe kratom products. Botanic Tonics is in full support of more stringent regulations, and supports the Global Kratom Coalition in advancing these stringent regulations across the nation. For more details, please reference the addendum titled `California Kratom Regulation_v1'. To put it plainly, I believe concern about kratom comes from a lack of dialogue and understanding. It resembles the "reefer madness" phenomenon from nearly a century ago, where exaggerated fears and misconceptions led to unwarranted stigmatization and restrictive policies. If given the opportunity, I would welcome the opportunity to talk through these backgrounders. I can also describe how good players in the industry are seeking to introduce products that have positive benefits for consumers with their safety in mind. In the meantime, my request is that you consider delaying putting the measure to ban kratom in Newport Beach in front of the City Council until you have heard from the industry. Sincerely, JW Ross le&d-d- Founder Botanic Tonics Kratom Regulatory Landscape: Kratom is legal to sell and consume in 44 states. o Of those states: ■ 11 states have passed the Kratom Consumer Protection Act (KCPA) ■ 12 states are actively considering passing the KCPA. • Kratom is banned to sell and consume in 6 states. o No state has passed a new ban since 2017. o Of the 6 banned states, 4 states are considering repealing their ban based on updated science and understanding of kratom and it's safety profile. California and Kratom: Legislators, scientists, consumers, and industry recognize the therapeutic potential of kratom and the benefits it provides to those who use it. At the same time, there is an understanding that comprehensive legislation is required to protect consumers and ensure their access to safe, responsibly manufactured kratom products. Due to the absence of federal regulation, states are currently responsible for putting forward their regulations. In the context of California, AB 2365 was filed on February 12th, 2024. AB 2365 is the strongest Kratom Consumer Protection bill passed by any state. It considers the realities of the kratom marketplace, the latest scientific findings, the distinction between different kratom formulations, and the need for more informed consumption to protect consumers and responsibly maintain access to safe kratom products. In the face of past concerns about kratom, some cities and councils have rushed to the conclusion of banning it. However, localized bans do not change consumption habits, as consumers may simply travel outside the ban lines to obtain their products, and law enforcement loses control of the problem (if there is, in fact, a problem at all). With robust state regulations in progress addressing issues in the kratom marketplace while still maintaining consumer access, a ban in Newport Beach would be prematurely implementing a solution that may not effectively address the issue. Summary of the Kratom Regulation Bill for California: 1. Clearly define what is and what is not kratom, and not allow adulteration: a. Kratom Leaf: The leaf of the kratom plant, subjected to minimal post -harvest processing. b. Kratom Leaf Extract: Material obtained by extracting kratom with specified solvents, containing mitragynine as the predominant alkaloid. c. Kratom Product: Food or dietary supplement containing kratom leaf or extract, excluding synthesized kratom constituents or any adulterants, and limiting 7- Hydroxymitragynine levels found in kratom products to under 1 % of total alkaloids. 2. Set packaging and labeling standards: a. Retail package labels must comply with federal allergen labeling requirements. b. Labels must include age restrictions (18+), health warnings, manufacturer information, and directions for use including the recommended serving size, and the amount of servings that can be safely consumed in a day. c. Liquid kratom products limited to 3 servings in containers, unless equipped with a calibrated measuring device. Powdered products must have calibrated measuring devices. 3. Prohibition of sale to person under 18: a. The sale of kratom products to persons under the age of 18 is prohibited. 4. Registration: a. Processors require a valid annual registration from the Department. b. Registration includes a certificate of analysis from an accredited third -party laboratory. c. Processor must pay an annual fee covering administrative costs. d. Failure to comply with testing or fee requirements will result in revocation of registration. 5. Enforcement: a. Violations will lead to denial, suspension, or revocation of registration. b. Proceedings follow the guidelines outlined in the Government Code. O N E 2024 DI• BOTANIC TONICS 13105 E. 61st Street, Suite B Broken Arrow, OK 74012 www.botanictonics.com hi@botanictonics.com +1-888-851-8546 2 DI Botanics Tonics is inspired by the functional benefit of plants. Our founder, JW Ross, discovered plants as a tool for wellness on his journey of healing. This is how Botanic Tonics and feel free were born. U Botanic Tonics cares about quality and doing things the right way. All of our kava-forward products are made in our FDA -registered, cGMP- certified production plant in Broken Arrow, Oklahoma. We actively support regulations that ensure consumer safety through robust labeling requirements, product testing, and the use of leaf kratom only, not kratom extracts, concentrates, or isolates. E Botanic Tonics is led by science. Evidenced by our large investment in clinical trials, consultation with leading functional experts and scientists, and world - class Research & Development team, we strive to ensure our products are in line with the latest science. We don't make claims that aren't supported by empirical evidence. Botanic Tonics brings products to the world that help people live better lives. We do this by introducing consumers to kava-forward functional herbal supplements using botanicals like kava root, leaf kratom, kola nut, rhodiola, and lion's mane. Botanic Tonics has an exceptional safety record. Not only as a kava-forward product, but also relative to other supplements and products. Overall, our customers report positive experiences with our products when consumed as recommended, with rare cases of minor adverse events. Since our inception, no verified severe incidents (hospitalizations or deaths) have been reported. O Botanic Tonics is dedicated to educating consumers. We're dedicated to educating about the relative safety of all our active ingredients as a means to provide productivity enhancement and to combat occasional stress and anxiety. Education and informed consumer choice are at the core of everything we do. WWW.BOTANICTONICS. COM CONTENTS OUR STORY 4 OUR PRODUCTS 6 BOTANICALS FEEL FREE CLASSIC AND FEEL FREE 03. TESTIMONIALS 8 04. DOING THINGS RIGHT 10 LABELING INGREDIENTS CONSUMER PROTECTION SAFETY 11 OUR FACILITY INCIDENCE REPORTING SCIENCE AND OBJECTIVITY 12 LEAF KRATOM AND ITS EFFECTS LEAF KRATOM IS NOT AN OPIOID LEAF KRATOM ADDICTION PROTECTING CONSUMERS CLINICAL DATA ON FEEL FREE CLASSIC LEAF KRATOM CONSUMER EDUCATION 16 U.S. KRATOM MARKET NOT ALL KRATOM IS EQUAL KRATOM'S DANGERS IN CONTEXT POISON CONTROL CENTER STATISTICS FAERS ADDITIONAL FACTORS OF KRATOM DEATH ANALYSES LEGALITY 20 UNITED STATES INTERNATIONAL CONCLUSION 21 BOTANIC TONICS PRESS DOC OUR STORY A PLANT -POWERED TRANSFORMATION Prior to founding Botanic Tonics, JW Ross built a career in the oil and gas industry. Embracing the "work hard, play harder" mentality, JW turned to alcohol and drugs to help cope with the stress and social anxiety he felt. Seeking a better way of life, JW discovered that certain plants could serve as a powerful alternative for mood enhancement. When incorporated with a healthier lifestyle including regular meditation, yoga, and a balanced diet, JW no longer felt the need to consume alcohol. THE BIRTH OF FEEL FREE With this new understanding of the functionality of plants, JW sought to create a product that gave him the same productivity enhancement, mood lift and calm as he had experienced during his travels in the South Pacific and Southeast Asia. After years of tinkering with different combinations of plants, he landed on a unique kava-forward blend of 10 parts kava root actives (kavalactones) to 1 part leaf kratom actives (alkaloids). From this "CLASSIC" formulation, Botanic Tonics and feel free were born. HONORING THE CULTURE OF KAVA One of the core beliefs of Botanic Tonics is a committment to supporting small, individual farmers who grow and harvest kava the same way they've done for centuries. Used traditionally for recreation and wellness, kava is the most sacred and profitable crop for Vanuatu farmers. COMPANY TIMELINE MAY 2020 �O The original feel free formula launches for sale O� OCT 2021 feel free passes 100,000 servings sold in a month SEPT 2022 feel free passes 1 million servings sold in a month O� NOV 2022 Botanic Tonics' facility is registered with the FDA DEC 2022 �O feel free launches in capsule form O� MAY 2023 the original feel free formula is renamed feel free CLASSIC and a new, kratom-free version assumes the feel free name JUNE 2023 �O Botanic Tonics' facility receives cGMP certification through Intertek O� JUNE 2023 feel free passes 2 million servings sold in a month OCT 2023 �O feel free CLASSIC begins selling in Southwest Circle K locations I O� DEC 2023 feel free passes 3 million servings sold in a month BOTANIC TONICS PRESS DOC OUR PRODUCTS Botanic Tonics offers a range of kava-forward herbal supplements under the feel free CLASSIC and feel free brands. Each product is thoughtfully crafted to provide a calm, focused energy. Our products are sold in both tonic (2 oz bottles) and capsule form. BOTANICALS Our kava-forward products use high -quality botanicals like kava root, leaf kratom, kola nut, rhodiola, and lion's mane —ancient plants that have been used around the world in social and wellness practices for centuries. KAVA ROOT Kava root, native to the Pacific Islands, has historically been used to relieve occasional stress and promote relaxation I:N]WEi!ILIA i Kola nut is the seed of the plant native to the rainforests of West Africa, and contains caffeine, which can provide a natural boost of energy and improve mental alertness. LEAF KRATOM Leaf kratom is from a tropical evergreen tree in the coffee family, native to Southeast Asia, where it has traditionally been used as an energy, endurance, and mood enhancer. Leaf kratom does not include kratom extracts, concentrates, or isolates. 1:103R]IIQWill Rhodiola, a flowering herb that grows in cold regions such as the Arctic and the mountains of Europe and Asia, can enhance cognitive function, increase energy levels, and reduce occasional stress. W__ NIi-1; - -.110_` 4IIQkgN1027AIFA►14 Lion's mane is an edible mushroom — often referred to as the "smart mushroom" for its purported ability to support brain function — that has been used in traditional Chinese medicine for centuries. WWW.BOTANICTONICS.COM FEEL FREE CLASSIC AND FEEL FREE Botanic Tonics offers two product lines — feel free CLASSIC and feel free — in both tonic and capsule form. Tonics come in 2 oz. bottles (2 servings) and capsules come in 90-count bottles (30 servings) as well as 12 6-count pouches (24 servings). KAVA ROOT promotes relaxation —LEAF KRATOM enhances energy & focus FEEL FREE CLASSIC feel free CLASSIC, launched in May 2020, contains kava root and leaf kratom, does not contain caffeine, and aids in relaxation, productivity, and focus. KAVA ROOT promotes relaxation KOLA NUT enhances energy FEEL FREE LION'S MANE boosts cognitive 0 function _ RHOOIOLA increases focus feel free, launched in May 2023, contains kava root, naturally-caffeinated kola nut (100mg per serving), lion's mane, and rhodiola. The effects of both products are generally felt within 15-30 minutes of consumption and last for 2-4 hours. An overview of the differences between feel free CLASSIC and feel free. BOTANIC TONICS PRESS DOC TESTIMONIALS We have received hundreds of independent reviews from consumers of feel free via our website, where 86% of users give feel free CLASSIC 5 stars. More importantly, more than 250 consumers have sent us written affidavits describing the profound impact feel free has had on their lives. Here are some of those testimonials: CARA I DEWITT, MI "I absolutely love feel free'. I've been using the product 3-4x/week for the past 6 months and I've told everyone how amazing it is. There are detailed instructions on the bottle and on their website. The instructions are to drink no more than 1/2 the bottle at a time. That is all you need. The company is very specific about the strain of plants used to ensure quality and safety. I'm not crazy about the taste, so I follow the serving with a large glass of water, but others I know think the taste is just fine. The wonderful thing about this tonic is that it is very subtle —I feel calm and peaceful yet I also am able to concentrate even better while working. It does not make you sleepy or jittery like the effects of too much caffeine. I use this while at work, before socializing, and often before I exercise. The main effect is a sense of well-being. You do not feel `high' or intoxicated or under the influence. You are able to perform any type of activity. I never notice the effects wearing off, they just gradually diminish over 3-4 hours. I have no problems with headaches or an upset stomach" AUDRA I CLEARWATER, FL "I love feel free. I went through a really stressful time last year in my personal life. At the same time I was put in a place of leadership professionally. As a shy and introverted person this was adding additional stress on me. I used feel free and it dramatically helped to calm down, ease stress, and feel more energetic. It also helped to ease social anxiety and helped me to be more talkative and authoritative in my new leadership role. I love the stuff! It's a special occasion thing for me now. I save it to help me with in-law visits and other stressful situations as it's out of my budget to use regularly. It caused no health issues for me. It actually made my body feel amazing. Not high, just at ease:" LEE I LANCASTER, CA "I've taken about 30 bottles of feel free over the last 2 months, and I have to say it really is life -changing. As someone who has relied heavily on caffeine and alcohol for years, finding feel free has allowed me to drastically reduce my intake of both of those substances, and I feel so much better. I use it primarily as a pre -workout, and the effect is quite remarkable. I get a very distinct sense of overall well-being, a calm focus, and my endurance increases significantly. Thatjacked up, agitated energy that stimulant pre -workouts give me does not compare to the positive effects of feel free. I will also use it in the evening if I need a boost before a show (I'm a touring musician), or social event. The marked lack of anxiety is a big relief, vs. how I feel after caffeine. The mental clarity and settling of my nerves is actually better than alcohol, and my sleep data is so much better when I have feel free in the evening vs. drinking. I truly believe that using kava and kratom, in their traditional, natural form, can be incredibly beneficial to millions of people, when tested and regulated properly." BENOIT I VENICE, CA "I have been using feel free bottles since December 2022.1 decided to stop drinking alcohol and was feeling quite uncomfortable in social gatherings. I have been using alcohol as a social lubricant for many many years and being social was getting harder and harder. I came across feel free and tried it. I felt the effect right away; my mood was lifted with a sense of general happiness. This was my secret weapon to considerably reduce my alcohol intake and be comfortable again. I now use it also for boring tasks, like work on the computer. It really helps get things done; mood elevation and focus at the same time. For me it is a total game changer." ' Please note that when customers' testimonials refer to feel free, they are referring to the product now known as feel free CLASSIC; at the time of submission, it was still known as feel free. The distinction is notable because feel free CLASSIC contains leaf kratom, while present-day feel free does not. So customers are referring to the product containing leaf kratom. BRIAN I ALLEN, TX "I am an occasional user of kratom and kava. I have no chronic pain so this is not an endorsement due to any kind of need. I am a father of 4, 47 years old, athlete, and I work a professional career as a managing director of an IT services company. I use both kratom and kava about 1-2 times per week for the following benefits: to relax the stress at the end of a hard day and transition to family time, also on weekend mornings to have a really great workout and get a lot of things done. Kava presents to me as all the things alcohol wishes it was: no cognitive impairment, short-term effect (90-120 min.), relaxing without destroying the evening and low -calorie. Kratom is everything coffee wishes it was: long-term acting without a crash, cognitive stimulation, no jitters, and when it's finished, it's finished, it doesn't linger." JESSIE I RHINEBECK, NY "feel free is a game -changer for me. I've tried Thesis and Avantera to help with energy and focus and nothing really worked until I found feel free. I'm a hairstylist, musician, and single mom and feel free is exactly the answer for me to be able to power through work, parenting, and all of my creative musical pursuits. I'm also naturally an introvert and have used alcohol in the past to feel more at ease in social situations; feel free helps me with that too. When I take this amazing supplement I'm at ease in my body, comfortable around friends and people whom I'm just meeting for the first time. I still have a drink now and then but it's because I want to taste a delicious cocktail not because I want to suppress my anxiety. I cannot recommend feel free enough, nothing worked until I found feel free." I used feel free and it dramatically helped to calm down, ease stress, and feel more energetic. It also helped to ease social anxiety and helped me to be more talkative and authoritative in my new leadership role. JOSHUA I COSTA MESA, CA "I first tried feel free a little over 1 year ago and was immediately surprised at the positive effects I experienced. My wife and I have used it consistently ever since and both of our lives have benefited greatly. My main use of feel free is each day at work for increased energy, focus, and productivity. I also use it for increased stamina before a workout and occasionally as an alcohol alternative in the evenings. I can honestly say the use of feel free has benefited most aspects of my life over the past year. It has helped me to be more successful at work and to better engage and serve my family at home. I am also healthier and drink far less alcohol than I used to. I'm grateful to have found a supplement that truly works." JILLIAN I ST. PETE BEACH, FL "feel free by Botanic Tonics offers a wide variety of benefits, from increased energy, to enhanced focus, to a calmer disposition, and beyond. I find it to be a fantastic alternative to many synthetic products on the market and I love that Botanic Tonics goes above and beyond in their testing for purity and potency. Both kava and kratom have long been used by indigenous cultures, and as with any substance both sourcing and intention are key. I trust Botanic Tonics in their commitment to providing the best ingredients, in the optimal formulation, for the most efficacious and responsible delivery." BOTANIC TONICS PRESS DOC DOING THINGS RIGHT LABELING We are transparent in communicating our products' ingredients, recommended serving sizes, recommended daily intake, directions for consumption, and warnings for safe use —as seen on the product label for feel free CLASSIC, to the right. INGREDIENTS We source our ingredients from regions of the world where they are indigenous, including Southeast Asia and the Pacific Islands. All ingredients are lab -tested and each product batch is tested multiple times to ensure the level of active ingredients is consistent. We also conduct safety tests for heavy metals and contaminants. The label of feel free CLASSIC. CONSUMER PROTECTION Botanic Tonics takes an active role in ensuring that consumers have access to responsibly manufactured and safe leaf kratom products through: Support of the Kratom Consumer Protection Act (KCPA). The KCPA legislates for age restrictions, appropriate labeling and packaging standards, and unadulterated kratom products. It is imperative that consumers are equipped with the information they require to make informed choices about consumption. Support of Leaf Kratom Coalition, which is actively involved in funding and supporting leaf kratom science and education. The Leaf Kratom Coalition believes that regulation should be informed by science to ensure consumer safety, and supports the use of unadulterated leaf kratom material, such as that used in Botanic Tonics' products. The Leaf Kratom Coalition does not support kratom extracts, concentrates, or isolates. WWW.BOTANICTONICS.COM SAFETY OUR FACILITY Botanic Tonics' kava-forward products are manufactured in our FDA -registered production plant in Broken Arrow, Oklahoma. The facility is cGMP certified by Intertek, the leading global Good Manufacturing Process auditing firm. The facility has high quality standards, which includes testing for pesticides, aflatoxins, and heavy metals using ultraperformance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) and inductively coupled plasma mass spectrometry (ICP-MS). Microbiological analysis is performed in order to detect any illness -causing bacteria, yeast, or mold in our product. A certified third -party lab, along with our in-house laboratory, conduct tests on every batch to ensure product integrity. We also use only gamma irradiated leaf kratom. Gamma irradiation is routinely used to sterilize medical, dental, and household INCIDENCE REPORTING Our customers' reports of adverse events have declined as consumption of our products has increased. Currently, adverse events as a percentage of total servings is 0.0005%. This equates to 1 non -severe incident (nausea, heartburn, headache, etc.) for every 180,022 servings consumed. Moreover, these reports include no verified severe incidents, which are those that result in hospitalizations or deaths. products. The FDA has evaluated the safety of irradiated food for more than 30 years and has found the process to be safe. The World Health Organization, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture have also endorsed the safety of irradiated food. Any raw material or finished product that does not conform to acceptable microbial specifications is quarantined and disposed of. The amount of active compounds can vary from batch to batch in botanical products. We strive to stay within ± 10% variability in the active content of our tonics. Our Research & Development and Quality Control teams work together, meticulously, to make the necessary adjustments to the formulation to ensure that variations stay within an acceptable range for a consistent product. Servings vs Incidence Rate % - Jan 2021 to Nov 2023 - - • - 000— °` Source: Botanic Tonics BOTANIC TONICS PRESS DOC SCIENCE AND OBJECTIVITY We believe in the importance of leading with science, particularly in an industry where data can be difficult to understand. From the very beginning, we've invested not only in getting the right equipment to analyze the quality of our raw materials and finished products, but also in funding clinical trials and supporting research to better understand leaf kratom use in the United States. LEAF KRATOM AND ITS EFFECTS Leaf kratom is from a tropical evergreen tree (Mitragynaspecioso) native to Southeast Asia. Leaf kratom contains over 40 alkaloids, most of which have unknown pharmacological effects. Leaf kratom does not include kratom extracts, concentrates or isolates. The most abundant alkaloid in leaf kratom is mitragynine, and assuch isthought to account for most of the effects after consumption of leaf kratom. Mitragynine does not have strong rewarding or addictive effects, nor respiratory depressant effects like traditional opioids and/or conventional stimulants.2 Minor alkaloids found in leaf kratom have not been studied in traditional preclinical models of abuse potential. LEAF KRATOM IS NOT AN OPIOID Leaf kratom is not an opioid, though its compounds, like those of many other substances, interact with the opioid receptor system. When it comes to the opioid receptor system, there are numerous compounds that interact with and activate this system that are commonly consumed, such as many dairy products and compounds ingested from barley and gluten.3 Additionally, sugar triggers the production and release of endogenous opioid compounds.4 Compounds found in leaf kratom interact with opioid receptors, as well as multiple other receptor system types. The distinction between the aforementioned compounds and the illicit and prescribed opioids that are driving the opioid epidemic is in the downstream effects of these compounds. Drugs like heroin and codeine strongly interact with the µ-opioid receptor subtype, which triggers G-protein coupled receptors downstream causing the deleterious side effect of respiratory depression which can lead to overdose. Research looking at the major compound found in leaf kratom (mitragynine) has shown that respiratory depression is not triggered.5 LEAF KRATOM ADDICTION In general terms, addiction is defined as a medical disorder. The National Institute on Drug Abuse defines addiction as a "chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences"6 Having a physiological dependence to a substance does not necessarily mean that a person has an addiction to that substance. There are few documented reports of leaf kratom addiction globally. One review of clinical case reports found only 55 cases in which a clinician evaluated, in some manner, symptoms related to leaf kratom physical dependence or addiction -like symptoms.' In regions where leaf kratom is indigenous, Malaysia and Thailand in particular, there have been self -reports of mild to moderate symptoms of craving, tolerance, 2 Henningfield, J., et. al. Kratom Science Update: Evidence -Based Facts, Kratom Science Updates, October 2022. a Tyagi, A.; Daliri, E. B.; Kwami Ofosu, F.; Yeon, S. J.; Oh, D. H., Food -Derived Opioid Peptides in Human Health: A Review. Int J Mol Sci 2020, 21 (22). ° Avena, N. M.; Rada, P.; Hoebel, B. G., Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neuroscience and biobehavioral reviews 2008, 32 (1), 20-39. 5 Henningfield, J. E.; Rodricks, J. V.; Magnuson, A. M.; Huestis, M. A., Respiratory effects of oral mitragynine and oxycodone in a rodent model. Psychopharmacology 2022, 239 (12), 3793-3804. 6 National Institute on Drug Abuse (NIDA). Drug misuse and addiction. (2020, July 13). Retrieved December 21, 2023, from https:Hnida.nih.gov/publications/ drugs-brains-behavior-science-addiction/drug-misuse-addiction. Smith, K. E., Feldman, J. D., Schriefer, D., Weiss, S. T., Grundmann, O., Dunn, K. E., ... & Epstein, D. H. (2023a). Diagnostic ambiguities and underuse of clinical assessment tools: A systematic review of case reports on kratom addiction and physical dependence. Current Addiction Reports, 10(2), 282-292. WWW.BOTANICTONICS.COM and withdrawal among people who consume leaf kratom regularly. However, the functioning of these regular consumers does not show clear impairments that would be typical of a substance use disorder or addiction; rather there is more indication for physical dependence. 89101111 Similar to reports from Southeast Asia, where many use leaf kratom daily as part of everyday life, the social, psychological, occupational, and daily functioning of people who use leaf kratom in the U.S. does not seem impaired, even in cases where physical dependence signs are present.111415 Interviews undertaken by researchers at NIDA found that some regular U.S. leaf kratom consumers did not report withdrawal symptoms, whereas others had mild withdrawal, but all described how leaf kratom was a routine part of their daily and weekly routines16Individuals who use leaf kratom regularly are not showing impairments in daily functioning or hazardous use. This makes sense when we remember that some of the reasons why people use leaf kratom are often to be productive and highly functioning in their everyday lives1711 So, while there is presently some evidence to suggest that regular or prolonged use of leaf kratom may result in tolerance or withdrawal and physical dependence, there is no evidence to support assertions that leaf kratom use is resulting in concerning symptoms of compulsive use despite adverse consequences. What seems most likely to occur from regular, prolonged use of leaf kratom, particularly at high servings or by use of concentrated extracts, is dependence, not addiction. And notably, Google search results from 2004 to now put into perspective the public's concern over so-called "kratom addiction" versus that of other popular substances. ■orawneascr •cpfid adakGon �wr�aredatGon ■akMNSWtGf+� ■Kam eaGcm+ `+w:•--: �...,Yi.�� acF�rm 5ewe�!h+Se�t�lem N.I[651eerb soaa-❑eun • aq ceu9e.�n 'Ab65wrn • Interest O r Sims (5 r �) I h •w �„�I'•�l.��1 --- Source: Google 8 Saingam, D., Singh, D., Geater, A. F., Assanangkornchai, S., Jitpiboon, W., & Latkin, C. (2023). The Health Impact of Long -Term Kratom (Mitragyna Speciosa) Use in Southern Thailand. Substance Use & Misuse, 1-14. 9 Singh, D., Narayanan, S., & Vicknasingam, B. (2016). Traditional and non-traditional uses of Mitragynine (Kratom): A survey of the literature. Brain Research Bulletin, 126, 41-46. 10 Singh, D., Muller, C. P., & Vicknasingam, B. K. (2014). Kratom (Mitragyna speciosa) dependence, withdrawal symptoms and craving in regular users. Drug and alcohol dependence, 139, 132-137. 11 Singh, D., Muller, C. P., Vicknasingam, B. K., & Mansor, S. M. (2015). Social functioning of Kratom (Mitragyna speciosa) users in Malaysia. Journal of Psychoactive Drugs, 47(2), 125-131. "Singh, D., Narayanan, S., Muller, C. P., Swogger, M. T., Rahim, A. A., Leong Bin Abdullah, M. F. I., & Vicknasingam, B. K. (2018). Severity of kratom (Mitragyna speciosa Korth.) psychological withdrawal symptoms. Journal of psychoactive drugs, 50(5), 445-450. 13 Garcia-Romeu, A., Cox, D. J., Smith, K. E., Dunn, K. E., & Griffiths, R. R. (2020). Kratom (Mitragyna speciosa): user demographics, use patterns, and implications for the opicid epidemic. Drug and alcohol dependence, 208, 107849. 14 Smith, K. E., Dunn, K. E., Epstein, D. H., Feldman, J. D., Garcia-Romeu, A., Grundmann, C., ... & Weiss, S. T. (2022a). Need for clarity and context in case reports on kratom use, assessment, and intervention. Substance Abuse, 43(1), 1221-1224. 16 Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. 1, Grundmann, C., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology, 14, 1174. 16 Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. 1, Grundmann, C., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology, 14, 1174. 17 Grundmann, O., Veltri, C. A., Morcos, D., Knightes III, D., Smith, K. E., Singh, D., ... & Swogger, M. T. (2022). Exploring the self -reported motivations of kratom (Mitragyna speciosa Korth.) use: a cross -sectional investigation. The American Journal of Drug and Alcohol Abuse, 48(4), 433-444. 1$ Smith, K. E., Dunn, K. E., Rogers, J. M., Grundmann, O., McCurdy, C. R., Garcia-Romeu, A., ... & Epstein, D. H. (2022d). Kratom use as more than a "self - treatment". The American Journal of Drug and Alcohol Abuse, 48(6), 684-694. BOTANIC TONICS PRESS DOC PROTECTING CONSUMERS Botanic Tonics is committed to protecting the well-being of its consumers. Cautionary and warning language is being added to products to include the below language: CLINICAL DATA ON FEEL FREE CLASSIC Botanic Tonics is committed to understanding how feel free CLASSIC is processed by the body (pharmacokinetics) and affects the body (pharmacodynamics). A single - dose study of feel free CLASSIC in 12 naive individuals was performed to determine the time course of the active compounds. It was found that upon coadministration of leaf kratom and kava, no significant changes were seen in the pharmacokinetics of any of the active constituents. The main study of the clinical trial is a crossover, placebo -controlled, double-blind study in 40 naive participants assessing the effect of feel free CLASSIC on mood, mental health, cognition, hematology, and clinical chemistry, as well as assessing abuse potential using both the clinical opiate withdrawal scale and the subjective opiate withdrawal scale. The study has been completed in >30 participants and results will be available in early 2024. jO► �Ss I C BABIED H E R B A L SuPPLEMEW,, Z FL 02 [59m1, Botanic Tonics exists to help people make the most of the moments that matter. BOTANIC TONICS PRESS DOC LEAF KRATOM CONSUMER EDUCATION The news is rife with confusion, conflation, and misinformation about leaf kratom, our products, and even us. The main issue is that there is a very low understanding that not all kratom is the same. Leaf kratom, like what has been consumed for decades in Southeast Asia, is not the same as the kratom extracts, concentrates, and isolates that are now being sold in the U.S. An analogy to this would be the difference between CBD and high-THC content cannabis products. As a company operating in this reality, we take seriously our responsibility to consumers —to ensure they are provided specific and data -driven information about our products so that they can make the best choices for their own best interests. That is why our website includes a "Learn" section with details on our products' ingredients, blog posts about wellness and botanicals, and FAQs and answers about our business and products, among other resources. But our commitment to education extends beyond these webpages; it is fundamental to who we are and how we operate within our industry and news environment. We hope to cut through the noise created by documentaries and clickbait articles with evidence, context, and analysis. U.S. KRATOM MARKET While it has not been determined exactly how many people in the U.S. consume kratom products, a 2021 study identified approximately 2 million users, while other estimates range between 2-15 million. 192021 According to the Botanical Education Alliance, the industry contributes $1.13 billion to the U.S. economy. The continued growth of kratom use in the U.S. adds urgency to the goal that consumers are informed about how they can choose to use kratom. 19 Veltri, C., Grundmann, O., Current perspectives on the impact of Kratom use. Subst Abuse Rehabil 2019, 10, 23-31. 20 Schimmel, J., Amioka, E.; Rockhill, K.; Haynes, C. M.; Black, J. C.; Dart, R. C.; Iwanicki, J. L., Prevalence and description of kratom (Mitragyna speciosa) use in the United States: a cross -sectional study. Addiction 2021, 116 (1), 176-181. 21 Singh, D.; Brown, P. N.; Cinosi, E.; Corazza, O., Henningfield, J. E.; Garcia-Romeu, A.; McCurdy, C. R.; McMahon, L. R.; Prozialeck, W. C.; Smith, K. E., Swogger, M. T; Veltri, C.; Walsh, Z.; Grundmann, O., Current and future potential impact of covid-19 on kratom (Mitragyna speciosa Korth.) supply and use. Front Psych 2020, 11, 574483-574483. WWW.BOTANICTONICS.COM NOT ALL KRATOM IS EQUAL As for any product, distinctions should be drawn between high- and low -quality ingredients, responsible and irresponsible business practices, and, ultimately, good and bad actors. In terms of kratom, the starting point for these distinctions is that feel free CLASSIC uses leaf material, which has been used safely for centuries in Southeast Asia, as opposed to extracts, which are meant to isolate and/or concentrate certain compounds in the plant. Some manufacturers, for example, have been known to boost their products' 7-hydroxymitragynine content, which can only be accomplished through chemical manipulation of leaf kratom material or by adulterating products with dangerous compounds. 2223 Moreover, alkaloids in extract formulations enter the bloodstream more rapidly, so the effects hit much more quickly after ingestion. Leaf kratom, meanwhile, taken in a tonic or capsule form, absorb slower because they must be broken down by the digestive system prior to absorption. feel free CLASSIC uses only dried ground leaf kratom, processed with certified manufacturing standards to ensure its quality and unadulterated status. ---..or :0 -- - 22 Lydecker, A.G.; Sharma, A., McCurdy, C.R.; Avery, B.A.; Babu, K.M.; Boyer, E.W. Suspected Adulteration of Commercial Kratom Products with 7-Hydroxymitragynine. J Med Toxicol 2016,12, 341-349. Zz Kronstrand, R., Roman, M.; Thelander, G.; Eriksson, A. Unintentional fatal intoxications with mitragynine and O-desmethyltramadol from the herbal blend Krypton. J Anal Toxicol 2011, 35, 242-247. BOTANIC TONICS PRESS DOC KRATOM'S DANGERS IN CONTEXT When discussing kratom it is important to put its dangers in context of other widely used and available substances. This allows consumers to make more informed decisions. Below, the safety and abuse potential of kratom is discussed relative to other substances. POISON CONTROL CENTER STATISTICS The following graphs present statistics on calls to U.S. Poison Control Centers between 2017 and 2021, organized by substance (see "Calls per Substance"). When normalized by 100,000 users (see "Calls per 100K Users"), ibuprofen, a substance considered relatively safe, has the most calls to poison control centers, but these calls do not result in death. By far, the most deaths concern opioids, followed by alcohol and antidepressants. There were only 15 calls that resulted in death after kratom ingestion, whereas opioid calls that resulted in death were almost 1,500 in the same 5-year period (see "Calls Resulting in Deaths"). CALLS PER SUBSTANCE This graph presents total call numbers for each of the included substances. Calls regarding kava and kratom barely register. Of course, that is partly because kava and kratom are used far less frequently than these other substances. The following graph controls for this context. 160000 140000 120000 100000 80000 60000 40000 20000 I 0 eaa� W, Qc a 0 0a aati 0 Poison Center Calls per Substance 2017 to 2021 .2017 ■ 2018 .2019 .2020 -2021 Source: American Association of Poison Control Centers Poison Center Calls per 100,000 users 2017 to 2021 600 CALLS PER 100K USERS wo — 400 300 200 - Oo 1111� ..N11 o]111� ����■ ■���� 11111 W vc �e�° aE .mac 01 P° • 2017 0 2018 0 2019 0 2020 ■ 2021 o Fo �av This graph presents call numbers as proportions of an average sample of 100,000 calls. Again, calls for kava and kratom incidents barely register, comparing most closely with calls regarding energy drinks. Source: American Association of Poison Control Centers WWW.BOTANICTONICS.COM Poison Center Calls Deaths per Substance 2017 to 2021 500 472 CALLS RESULTING 450 55 IN DEATHS 400 350 And this graph presents 300 2 calls that resulted in 250 deaths, again putting the 200 risk associated with kratom 150 12 '114 consumption in context. 00 ° 150 I III 4 'l1' 1 �i1 0 =11562 41114 2 0101 1 10110 10110 12354 00000 0 e icy iQP cy w�9y 01 °ell cael o Q O° Q p° v- G S Bpi O eye acfp F,c P ■2017 ■2018 it it 2021 Source: American Association of Poison Control Centers FAERS ADDITIONAL FACTORS OF KRATOM DEATH ANALYSES It has been widely reported that kratom deaths are increasing at an "alarming rate." When reviewing the FDA Adverse Event Reporting System (FAERS), for kratom-related deaths, it is evident that the majority of deaths associated with kratom are linked to polysubstance use or other mitigating circumstances. This context is graphed below, between 2019 and 2021, showing a declining rate in kratom-only deaths. Kratom Death Analyses 2019 to 2022 This context is graphed here, between 2019 and 2021, showing a declining rate in kratom-only deaths. Source: Nutrasource independent review of FAERS, data 2019 to 2022 Poly Drug Use Other Circumstances/Needs more info �No additional factors In the context of overall substance use in the U.S., looking at CDC, FAERS and CAERS data, where sugar is included, the data illustrates that kratom presents a much lower risk than alcohol, tobacco, sugar, and opioids. Source: Nutrasource independent review of FAERS, CAERS, & CDC data, 2023 Summary - Comparison Death Rates (2021) Normalized per 100,000 users 120.00 100.00 95.83 80.00 60.00 40.00 25.41 20.00 1 0.00 Tobacco -Related Alcohol -Related Sugar -Related Mortality Mortality Mortality 1=$ 0.04 0.00 0.00 Opioids Kratom Marijuana K.— BOTANIC TONICS PRESS DOC LEGALITY 0 UNITED STATES • Kratom is legal to sell and consume in 45 states. Of those: • 11 states have passed regulations protecting consumers (i.e. KCPAs) • 20 states are actively considering regulations protecting consumers • 8 states have localized bans in certain areas • Kratom is illegal to sell and consume in 5 states. Of those: • 3 states are reviewing their bans 2023 Kratom State Legality & Legislation Source: American Kratom Association In 2016, the Drug Enforcement Agency tried and failed to classify kratom as a Schedule I drug. Public backlash (160,000 petition signatures) and calls to Congress resulted in the DEA withdrawing its intent to schedule. More recently, the FDA issued Import Alert 54-15, which broadly restricts the shipment of kratom from Indonesia to the U.S., and constitutes a proxy ban on the substance (97% of U.S. kratom imports originate from Indonesia). Generally, import alerts for botanicals are issued due to microbial or heavy metal contaminants, and then lifted once contamination is resolved. But in this case, the FDA considers all kratom materials to be adulterated due to end - product marketing and use, not because of any particular contaminant —removing any pathway to remediation. States with some known local bans are in yellow 0 INTERNATIONAL In 2021, the World Health Organization considered designating kratom a controlled substance internationally. Its Expert Committee on Drug Dependence concluded that there was "insufficient evidence to recommend a critical review of kratom," meaning there wasn't sufficient evidence to conduct a review, let alone designate kratom a controlled substance. WWW.BOTANICTONICS.COM CONCLUSION Botanic Tonics was founded with a vision to harness the functional nature of botanicals into kava-forward products that help people feel their best every day By sourcing ingredients from regions where they're indigenous and honoring the way they've historically been consumed, we can offer safe products that help people live better lives. From where our ingredients come from and how they're manufactured, to our transparency in labeling and marketing our products, we're proud to have done things the right way, and we're committed to continuously reflecting and improving on all parts of our business. Botanic Tonics has a core focus and passion for education. Reliable information and informed consumer choice are tenets that we base all of our decisions on. We have been and always will be guided by the latest science, and our investments in safety equipment, clinical trials, and other research testifies to our seriousness in doing things the right way. Additionally, leaf kratom, which is a part of our business, suffers from a news landscape that is incomplete at best and misleading at worst in that there is a lack of understanding that all kratom is not the same. There is a need for separate regulations for leaf kratom versus kratom extracts, concentrates, and isolates, and more transparency to ensure that consumers have access to safe products and have the information necessary for them to make informed choices. Sensational media coverage of kratom- related deaths (largely unfounded) clutters the news cycle, drowning out the largely positive impact that leaf kratom has on peoples' lives. Botanic Tonics supports regulations that protect consumers of leaf kratom products by establishing good manufacturing practices, robust labeling rules, age restrictions, and other requirements. At the same time, Botanic Tonics wants to ensure that consumers are aware of the tremendous positive benefits that leaf kratom can bring to a person's life if consumed responsibly. The overwhelmingly positive affidavits and reviews we receive testify to this truth, and serve as our guiding light. Moreover, we support continued research into leaf kratom, kava, and other botanicals, to grow the public's overall understanding as well as the science that informs best practices for manufacturers, regulators, and consumers alike. f .. r PLANT SOLUTIONS I 0 H 0 hi@botanictonics.com www.botanictonics.com +1-888-851-8546 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: ryanCabamericankratom.ora To: City Clerk"s Office Subject: Document Submission - 3/12/24 City Council Meeting Date: March 11, 2024 12:15:47 PM Attachments: AKA Policy Brief on FDA Shift on Kratom and CBD.odf AKA Policy Brief on kratom dose -finding study 022324 vfinal.pdf AKA Policy Brief on FDA Admission on Kratom Dancers 022324 vfinal W-l.odf California Kratom Regulation vl.pdf FDA Kratom Dancer Not Determined.pdf HHS Rescission Letter Dr. Giroir Aug 16 2018.pdf Kratom Science Update 2024.pdf AKA Kratom OA.ndf Good afternoon, Please include the attached documents with the agenda packet for the City Council Meeting being held tomorrow. If I can answer any questions or if you need any additional information, please let me know. Thank you, Ryan Ryan Burroughs 1 Executive Director (703) 919-3027 1 americankratom.ora I Ryan(a)americankratom.org 13575 Heathcote Blvd. Suite 320 Gainesville, VA 20155 � 1 AMERICAN KRATQM ASSOCIATION FDA Deputy Commissioner Signals Significant Shift in FDA Policy on Kratom and CBD Regulation. New regulatory approach exposes deep flaws in FDA's decades -long claims about kratom being dangerous as new FDA study finds "kratom appears to be well tolerated at all dose levels." (presented by FDA at scientific conference, February 2024) @8600e ALLIANCE FAR A STRONGER FDA ■ CBD and kratom are being marketed in almost every neighborhood you go into. ■ FDA has been thinking about what the regulatory framework for these products should look like. ■ Based on what the FDA knows about CBD, in particular, the Agency does not think that those products would be able to meet the safety standards currently in place for foods and dietary supplements today. ■ Given wide availability of both CBD and kratom, the FDA wants to make sure consumers are educated on what they are taking and that adverse events are reported and minimized - especially in children. ■ The FDA wants to work with Congress on this effort, which includes how to ensure that CBD and kratom products are clearly labeled with all ingredients, and that these products are not making their way into the hands of children, ■ All adverse events need to be quickly and accurately reported in such a way that the FDA can identify any trends. ■ FDA wants to know who is making the products containing kratom and CBD, where they are being made, and that they are manufactured or produced in a way that is safe. ■ This effort will take collaboration with the Hill and with stakeholders so the FDA can determine what regulations are needed to ensure the safety of the products and the level of oversight that will be required. Kratom Regulatory Landscape: Kratom is legal to sell and consume in 44 states. o Of those states: ■ 11 states have passed the Kratom Consumer Protection Act (KCPA) ■ 12 states are actively considering passing the KCPA. • Kratom is banned to sell and consume in 6 states. o No state has passed a new ban since 2017. o Of the 6 banned states, 4 states are considering repealing their ban based on updated science and understanding of kratom and it's safety profile. California and Kratom: Legislators, scientists, consumers, and industry recognize the therapeutic potential of kratom and the benefits it provides to those who use it. At the same time, there is an understanding that comprehensive legislation is required to protect consumers and ensure their access to safe, responsibly manufactured kratom products. Due to the absence of federal regulation, states are currently responsible for putting forward their regulations. In the context of California, AB 2365 was filed on February 12th, 2024. AB 2365 is the strongest Kratom Consumer Protection bill passed by any state. It considers the realities of the kratom marketplace, the latest scientific findings, the distinction between different kratom formulations, and the need for more informed consumption to protect consumers and responsibly maintain access to safe kratom products. In the face of past concerns about kratom, some cities and councils have rushed to the conclusion of banning it. However, localized bans do not change consumption habits, as consumers may simply travel outside the ban lines to obtain their products, and law enforcement loses control of the problem (if there is, in fact, a problem at all). With robust state regulations in progress addressing issues in the kratom marketplace while still maintaining consumer access, a ban in Newport Beach would be prematurely implementing a solution that may not effectively address the issue. Summary of the Kratom Regulation Bill for California: 1. Clearly define what is and what is not kratom, and not allow adulteration: a. Kratom Leaf: The leaf of the kratom plant, subjected to minimal post -harvest processing. b. Kratom Leaf Extract: Material obtained by extracting kratom with specified solvents, containing mitragynine as the predominant alkaloid. c. Kratom Product: Food or dietary supplement containing kratom leaf or extract, excluding synthesized kratom constituents or any adulterants, and limiting 7- Hydroxymitragynine levels found in kratom products to under 1 % of total alkaloids. 2. Set packaging and labeling standards: a. Retail package labels must comply with federal allergen labeling requirements. b. Labels must include age restrictions (18+), health warnings, manufacturer information, and directions for use including the recommended serving size, and the amount of servings that can be safely consumed in a day. c. Liquid kratom products limited to 3 servings in containers, unless equipped with a calibrated measuring device. Powdered products must have calibrated measuring devices. 3. Prohibition of sale to person under 18: a. The sale of kratom products to persons under the age of 18 is prohibited. 4. Registration: a. Processors require a valid annual registration from the Department. b. Registration includes a certificate of analysis from an accredited third -party laboratory. c. Processor must pay an annual fee covering administrative costs. d. Failure to comply with testing or fee requirements will result in revocation of registration. 5. Enforcement: a. Violations will lead to denial, suspension, or revocation of registration. b. Proceedings follow the guidelines outlined in the Government Code. 7 1 Jack Henningfield, PhD Kratom science increased almost exponentially over the past Vice President, Research, Health decade with more than 450 new scientific publications Policy and Abuse Liability, Pinney Associates, Adjunct Professor, addressing kratom safety, benefits, and abuse potential since Behavioral Biology, Dept of Psychiatry and Behavioral Science, early 2018, and more than 100 since the 2022 Kratom Science The Johns Hopkins University Update was developed. School of Medicine The science provides evidence to guide consumer safety leading to kratom regulations now passed into law in eleven states, with many more states considering such laws. As discussed below, these new scientific findings also led it the United States Department of Health and Human Services (US DHHS) to 2 Marilyn Huestis, PhD reverse its position on Controlled Substances Act (CSA) scheduling and, in August 2018, to rescind its earlier scheduling recommendation to the Drug Enforcement Science and Policy Advisor, Clinical Pharmacology and Toxicology, Administration (DEA). Cannabinoid and Other CNS-Active Pharmacotheraples, Senior Fellow, More recently in 2021, the World Health Organization Expert Committee on Drug Institute on Emerging Health Professions, Thomas Jefferson Dependence (WHO ECDD), thoroughly reviewed all the evidence for international University, Honorary Professor, Barts scheduling including written and oral statements from scientists around the world. and the London School of Medicine and Dentistry, Queen Mary The WHO ECDD concluded there was insufficient evidence to recommend University of London, President, Huestis & Smith Toxicology, LLC scheduling kratom, meaning the available data did not show public health risks of kratom warranting international restrictions. What is clearly needed is balanced regulation to ensure that kratom products purchased by consumers are pure and unadulterated, meeting the same types of standards applied to other food products, 3Oliver Grundmann, PhD and even bottled water. Steps toward such standards were taken in states that passed their own versions of kratom consumer protection act Clinical Professor of ofFloridalaws.Ultimately, e ooanru Administration Chemistry, University of Flid lthe Food D g Adiitti(FDA) ) needs to College of Pharmacy, President- develop national performance standards for kratom as it does for other Elect, American College of Clinical Pharmacology products. Such standards will help ensure access to kratom products that are appropriately marketed and are without contaminants and adulterants that might pose safety risks. This is the first annual update of the October 2022 Kratom Science Update. Many new studies related to kratom safety, the effects of its 'Albert Garcia-Romeu, PhD naturally occurring constituents, and the benefits reported by kratom Associate Professor, Psychiatry and consumers provide the basis for this 2023 update. The recent findings Behavioral Sciences, The Johns may also support implementation of regulatory efforts that were passed Hopkins , Guest R Schoosearc of into law in man states. Updates are provided at the end of each Medicine, Guest Researcher, y p National Institute on Drug Abuse subsection. Intramural Neuroimaging Research Branch Specific regulatory and policy approaches supported by new evidence. g The Food and Drug Administration (FDA) request to schedule kratom (specifically, mitragynine and 7- hydroxymitragynine) in Schedule I of the Controlled Substances Act (CSA), was reversed by the lead Department of Health and Human Services (DHHS) official charged with Controlled Substances Act recommendations to the DEA, namely, the Assistant Secretary of Health, Dr. Brett Giroir. Dr. Giroir requested a review of the evidence pertaining to kratom scheduling and safety, and concluded in August 2018, that the evidence did not support Schedule I placement. See a summary of the findings of the review in Dr. Giroir's formal 2018 scheduling rescission letter to the DEA at: 0https://static1.squarespace.com/static/54d5Oceee4bO5797b34869cf/t/60145eab6df59e7e36a7cfcl/16119476936 95/dhillon-8.16.2018-response-letter-from-ash-radm-giroir.pdf. The conclusions of the Assistant Secretary of Health were consistent with those of the National Institute on Drug Abuse (NIDA), which states on its Kratom Facts webpage that "While there are no uses for kratom approved by the FDA, people report using kratom to manage drug withdrawal symptoms and cravings (especially related to opioid use), pain, fatigue and mental health problems. NIDA supports and conducts research to evaluate potential medicinal uses for kratom and related chemical compounds." NIDA substantially expanded its kratom research support since 2017 and this research portfolio is rapidly expanding the evidence base for kratom regulation and possibly new kratom derived medicines in the years to come. Similarly, at the international level, the large evidence base was reviewed in 2021 by the World Health Organization Expert Committee on Drug Dependence (WHO ECDD) to determine if kratom met criteria for being placed on a critical review pathway for international scheduling. The WHO ECDD came to essentially the same conclusions as the Assistant Secretary of Health and NIDA. After conducting a thorough pre -review and a public hearing with input from leading international experts, the ECDD reported to the United Nations Office of Drug Control that there was insufficient evidence to recommend kratom for critical review but that it should be kept under surveillance. It also stated, "(k)ratom is used for self -medication for a variety of disorders but there is limited evidence of abuse liability in humans..." IAddressing overdose risks, the ECDD noted: "Although mitragynine has been analytically confirmed in a number of deaths, almost all involve use of other substances, so the degree to which kratom use has been a contributory factor to fatalities is unclear." Both the Assistant Secretary, and the WHO ECDD also acknowledge beneficial uses to abstain from opioids. Without labeling this as "therapeutic use", the Assistant Secretary clearly acknowledges such use and the public health risks of banning kratom. This nuanced recognition of benefits of use, along with risks of banning access to use by Assistant Secretary Giroir, was absent in the 2017 and early 2018 position of FDA, but was since recognized by the Secretary of Health Becerra in a letter to Senator Mike Lee and Congressman Mark Pocan on March 16. 2022.1 l https.Ilassets. website-files. com/61 eO7df3l2afed l3238eb7fl/6261 ab3O3b46bb88f2l b 6d 1 a_HHS % 2OKratom % 2OResponse. pdf Regulatory update: ME Uniform national regulation of kratom is vital because kratom product vendors vary widely in their product stewardship, quality control, and packaging and marketing related information and claims. Product testing revealed that some products were adulterated with dangerous substances and/or with high concentrations of mitragynine and other kratom alkaloids. Since October 2022, 4 additional states (West Virginia, Virginia, Florida, and Texas) enacted various laws to ensure continuation of legal kratom sales in their states, but with regulatory oversight laws generally referred to as the Kratom Consumer Protection Act (KCPA). This brings the total to 11 states that now have consumer protections in place. Several other states are considering similar regulatory frameworks. Although the KCPA provisions and standards vary somewhat across states, most include the following requirements for all products sold in the state: (a) registration of products and vendors, (b) labeling that discloses that products contain kratom as well as the name and contact information of the distributing vendors, (c) products must be tested to show they are not contaminated with heavy metals and toxins, that are consistent with the standards for food products such as oatmeal, tea leaves and coffee, or adulterated with drugs or boosted levels of mitragynine and 7-hydroxymitragynine (70HMG); (d) health claims are not permitted; and (e) the minimum age of purchase is either 18 or 21 years, depending on the choice of the state. Several more states are in various stages of consideration and action on similar proposed KCPA laws. Federal KCPA regulatory oversight has bipartisan support in the U.S. Congress with the filing of S. 3039, sponsored by Senator Mike Lee (R-UT) and Senator Cory Booker (D-NJ), and H.R. What is the current state of kratom science and evidence? Kratom was studied for decades, primarily in Southeast Asia (SEA), where kratom trees grow in abundance, but research escalated substantially in the US and globally with support by NIDA, SEA countries, and philanthropies. New science over the past 5-10 years includes investigations on kratom/mitragynine chemistry and medicinal development, neuropharmacology, brain imaging, preclinical and clinical studies, and surveys in the US and SEA. The rate of published kratom research continues to increase, along with presentations and symposia at a wide spectrum of national and international scientific meetings, such as the Society for Neuroscience, College on Problems of Drug Dependence, The International Conference on the Science of Botanicals, the International Association of Forensic Toxicologists and the Society of Forensic Toxicologists. 5905 sponsored by Congressman Mark Pocan (D-WI) and Congressman Jack Bergman (R-MI). The Federal Kratom Consumer Protection Act will provide a regulatory framework for kratom much like the Congress did in 1994 when they passed the Dietary Supplement Health and Education Act (DSHEA). Specifically, among other provisions requiring the FDA to publish standards for the manufacturing and marketing of kratom products, the Federal KCPA will (1) require full transparency of all taxpayer -funded scientific research conducted on kratom; (2) require the FDA to add peer -reviewed published kratom research articles to their kratom website; and (3) require transcripts of public hearings where independent scientific testimony on kratom is provided. These requirements will allow the public to see a balanced perspective on current research on kratom related to its safety, benefits, and addiction liability profile. Kratom research effort update The pace of kratom research and publication of peer -reviewed research remains rapid and continues to accelerate with expanded funding from government agencies in the US and internationally, as well as private sector efforts to support dietary supplement notifications and potential new drug applications derived from kratom. Since, October 2022, more than 450 new studies were published through October 2023, most supported by the National Institute on Drug Abuse (NIDA) and others from Southeast Asia. These studies provide the basis for the "Science Updates" noted at the end of each of the subsections in the November 2023 Kratom Science Update. The following summary and conclusions are based on peer - reviewed scientific publications, many conducted by international leaders in kratom research and supported by NIDA. A bibliography with links to key articles is provided. What is kratom? I N Kratom is a tree in the coffee family. Not surprisingly, its diverse effects include coffee -like alerting, stimulating, and mood enhancing effects, which are quite distinct from the effects of morphine -type opioids. It also has some opioid-like effects that include pain relief, possible opioid withdrawal symptoms after chronic frequent use and unpleasant side effects like constipation, but without the potentially lethal respiratory depressing or highly addictive brain rewarding effects that are driving the opioid epidemic. Is kratom an opioid? While some naturally occurring substances in kratom act on opioid receptors, kratom is not a prototypical opioid based on its chemical structure, botanical origins, or law — nationally or internationally. Like many natural products it has diverse effects and mechanisms of action that contribute to these effects and the reasons people use kratom. Some kratom constituents bind to opioid receptors and relieve pain whereas others do not. Unlike opioids which sedate and can impair mental functioning, kratom is used by many people in place of coffee for its alerting, mental focusing, and occupational performance enhancing effects. Who uses kratom and why? Animal and human studies, as well as neuropharmacology mechanisms of action studies, show that kratom does not carry the substantial opioid-like risks of deadly respiratory depression or powerfully addictive euphoria. A misunderstanding of one of kratom's self -reported beneficial uses, recognized by researchers and NIDA, providing relief of opioid withdrawal, is sometimes interpreted as evidence that it must be an opioid. In fact, the nonopioid adrenergic blocking drugs developed for treating high blood pressure, clonidine and Iofexidine, were prescribed for decades to treat opioid withdrawal. FDA approved Iofexidine (Lucemyra) for treating opioid withdrawal in 2018. Mitragynine, currently considered kratom's primary active compound, and other kratom constituents also produce adrenergic and other effects that might contribute to relief of withdrawal symptoms in people dependent on opioids, alcohol and stimulants. According to surveys in the US, most consumers are White adults, aged 35-55, with jobs and health care insurance, who report that their consumption is primarily for health and well-being. This includes consumption as an alternative to caffeinated products for alertness and increased focus, for the self -management of pain, and to improve mood. Many consumers state that kratom worked better for them, had fewer side -effects than the FDA -approved medicines they had taken, and/or that they preferred natural products. A smaller but important fraction of consumers are people who consider kratom as a "lifeline" or a path away from opioids. They use kratom to manage opioid withdrawal and reduce or eliminate opioid use. Update. Continuing surveillance and studies monitoring individual kratom consumers confirm the 2022 Update findings summarized above. However, new research provides additional insights into the reasons for use and effects of use that are important to consider in regulatory efforts. In brief, users primarily report use for a broad range of perceived benefits including energy and productivity, as well as to self -manage withdrawal and addiction to stimulants, alcohol and other substances in addition to opioids that have been the primary focus of earlier studies. Studies from NIDA by Dr. Kirsten Smith and colleagues found that whereas the motivations of many kratom consumers to initiate use were to address specific health concerns, many continue to use for additional reasons such as increasing energy and productivity, relaxation, and mood. Update: Kratom addiction related research findings. The percentage of people who reported becoming "addicted to kratom" is small based on early studies and new research; however, there is currently no objective basis for estimating this percentage in the US. Estimates of the fraction of kratom consumers who report addiction are confounded by many factors including the following: Many people equate "withdrawal symptoms' with addiction or a substance use disorder and apparently are not aware that the American Psychiatric Association, FDA, NIDA, and the World Health Organization acknowledge that withdrawal can occur with many substances that are not ordinarily considered addicting, and that withdrawal alone is not the basis for a substance use disorder or "addiction" diagnosis, as discussed in reports from these organizations in the bibliography; GSome people with prior addictions to opioids, stimulants, and alcohol used kratom to achieve abstinence from those substances and continue to use kratom, reporting addiction and difficulty discontinuing, in some cases in fear of returning to the far more deadly addictions that kratom helped them escape. Such use might be more appropriately considered "harm reduction" or therapeutic use, much as is maintenance of use of medicines such as antidepressants and approved addiction treatment medicines, such as buprenorphine and naltrexone, maintained long term to reduce the risk of relapse to the more deadly substances; GDistinguishing between the mood enhancing effects of kratom reported as therapeutic or beneficial in surveys from recreational users, and reasons that are not necessarily to address a specific disorder are not always clear. This is also the case with respect to reported kratom use to "improve sexual health" and as part of exercise regimens; GFinally, the factors that contribute to a diagnosis of a "substance use disorder" include personally and socially destructive aspects, and indicators of regular and compulsive use that are not necessarily a risk to personal health, violent crime, society, or the US drug overdose epidemic. Surveys and clinical studies confirm that kratom withdrawal can occur in some kratom consumers but is generally milder as compared to opioid and other drug withdrawal syndromes and generally self -manageable. Most kratom consumers do not experience withdrawal and although it is more likely in frequent multiple -times per day consumers, many such people do not report experiencing withdrawal upon discontinuation of kratom. People with chronic opioid use histories report that kratom provides relief of opioid withdrawal. As was discussed, alleviation of opioid withdrawal may be due to some of kratom's effects that are not mediated by opioid receptors but also by effects that are similar to those of medicines used to treat high blood pressure including one that is FDA approved for treating opioid withdrawal — lofexidine. These results are consistent with human reports that kratom may be therapeutically useful for managing opioid withdrawal though FDA has not approved kratom for this or any other medical use. Clearly more research is needed to guide consumer use and potentially support applications to FDA for acceptance and approval for such use. What led to increased kratom use in the United States? Although kratom was taken as a natural traditional medicine in SEA for centuries, its use in the US was largely limited to Asian immigrants from the early 1970s through the 1990s. In the early 2000s, with a rising general interest in natural products as alternatives to conventional medicines and growing public access to information via the Internet, kratom use began to increase. Reasons for use appear generally similar from the US to SEA, as an alternative to coffee and tea for its alerting and mild stimulant effects, to improve mood and relieve pain, and to manage withdrawal and help people to reduce or discontinue use of opioids, alcohol and other addictive substances. Many survey respondents report that kratom was either more effective, carried fewer side effects of concern such as the sedating effects of opioid pain relievers, and/or that they prefer natural products over conventional medicine. Estimates of the present market vary widely. By 2014, there were an estimated 3-5 million kratom consumers, and marketing and SEA export estimates suggest that the present market is 15 million or more in the US. One federal survey estimated between 2-3 million kratom consumers, which might reflect its panel of respondents. The federal survey is designed to track substance abuse and might underrepresent middle aged and older people with lower rates of recreational substance use who might use kratom for other reasons. Does kratom contain dangerous substances? Like its botanical cousin coffee, kratom contains many substances referred to as alkaloids, which tend to be somewhat alkaline and bitter in flavor. More than 40 alkaloids are identified in kratom to date, with most having little or no known pharmacological effect, or occurring at such low levels as to be of little cause for harm or benefit. However, as is the case with other natural products, the naturally occurring mixture of substances likely contributes to the overall effects and natural variations in alkaloid composition may lead to varying pharmacological effects. The main ingredient currently thought to account for most of the effects reported by kratom consumers is mitragynine, which does not have strong rewarding and addictive effects, nor respiratory depressant effects like opioids and conventional stimulants. The second most widely recognized substance is 7OHMG that has stronger opioid effects but occurs at levels that are often nondetectable in fresh kratom leaves. However, 7OHMG is also a product of mitragynine metabolism and its gradual elevation in the blood following oral consumption may contribute to some of the effects of kratom that are desired by consumers. Respiratory effects of kratom. In the absence of kratom regulation, some kratom makers boosted 7OHMG content far higher than that found in the native plant material, and this is a potential safety concern. States passing kratom consumer protection act laws ensure that legally marketed kratom does not contain boosted mitragynine or 7OHMG levels, contaminants, or other adulterants, thereby reducing public health risks. Additionally, dangerous substances like fentanyl and O-desmethyltramadol were found in adulterated kratom products. Regulation is needed from FDA to ensure that all US consumers are protected from risky exposure to contaminated or adulterated products. 611 It is well understood that kratom's respiratory effects are not like those of morphine -like opioids; however, research since 2018 support the conclusion that kratom is not simply weaker than opioids with respect to respiratory depression. Specifically, mitragynine and other alkaloids in kratom act as partial agonists at opioid receptors, meaning that their maximal effects reach a ceiling beyond which higher doses produce little additional effect". This was demonstrated in several animal species (including cats, dogs, mice, and rats) with mitragynine doses increased to levels far beyond what is or can be consumed by even high intake chronic kratom consumers. The most recent study employed a sophisticated rodent model developed by FDA to compare a broad range of mitragynine doses to therapeutic and toxic oxycodone doses across blood gases and other parameters. Whereas oxycodone produced the signature dose -related plummeting blood oxygen levels and deaths, mitragynine produced no evidence of respiratory depression at any dose, and no life -threatening effects. Can you overdose on kratom? Kratom acts as a partial p-opioid agonist that does not activate the (3-arrestin 2 pathway involved in respiratory depression. Thus, kratom is much less likely to contribute to overdose deaths than heroin, fentanyl, oxycodone or other potent opioids. When mitragynine, the primary alkaloid in kratom, is identified in overdose cases, it is almost always found along with active central nervous system drugs with known lethal potential. Nevertheless, kratom consumers should not assume that kratom is without risk, especially when combined with other drugs. One of the most important guidelines to consider before naming kratom or mitragynine as cause of death is to ensure that comprehensive toxicology testing is performed. In many cases in which kratom is found at the scene or in the decedent's home, and in some cases with mitragynine detected in a blood sample, investigators concluded it must have been involved in the death. However, routine toxicology does not identify other drugs that are increasingly known to cause overdose death, such as novel fentanyl related and other psychoactive substances. Most laboratories do not include kratom or mitragynine in their routine testing because of the lack of reports of kratom overdoses and deaths, necessitating The American Kratom Association recently published expensive analysis of autopsy specimens at reference guidelines on factors to consider prior to naming kratom or laboratories. Thus, only kratom testing is ordered and the mitragynine as cause of death. This was necessary because possible presence of other novel psychoactive substances is of the confusion following the FDA's announcement on not identified due to the additional cost that cannot be borne by February 6, 2018, that kratom was seriously harmful, with an poorly resourced local and state forensic laboratories. opioid-like death risk. The FDA listed 44 deaths occurring in kratom consumers, but only 1 did not include other respiratory depressing substances or other conditions that likely contributed to the deaths. For example, further investigation determined that the one kratom only case was a motor vehicle fatality. Centers for Disease Control scientists (2019) analyzed data from the State Unintentional Drug Overdose Reporting System (SUDORS) from 27 states over 18 months finding 152 or 0.56% of 27, 338 overdose deaths mentioning kratom in their postmortem toxicology reports. However, kratom was listed as cause of death in 91 or 59.9% of these cases, despite only 7 or 4.6% having kratom only identified by toxicology. The authors stress that the presence of other drugs cannot be ruled out as contributing to cause of death. Eighty percent of decedents had a history of substance misuse. In cases when kratom was identified, 65.1 % of fatalities also included fentanyl, 32.9% heroin, benzodiazepines 29.4%, prescription opioids 19.7% and cocaine 18.4%. Gershman (2019) recently investigated 15 kratom-related deaths over 18 years and found 11 were multidrug deaths including opioids, and four were kratom only deaths and attributed by the coroners to kratom toxicity. Blood was available for comprehensive toxicology testing in 3 cases and additional toxic drugs were identified in all of these cases. The last case had no blood available for additional testing. Mitragynine concentrations ranged from 16 to 4800 ng/mL. Some of the kratom associated death cases did not test for kratom but based the decision on crime scene investigation only, others had only a positive qualitative result confirming A recent study compared the respiratory effects of up to 400 mg/kg oral mitragynine to up to 150 mg/kg oral oxycodone in rats according to the study design published by FDA. Oxycodone significantly depressed oxygen saturation and sedated the animals with two deaths at the higher doses. Mitragynine did not significantly depress respiration or produce life -threatening effects, even at these exceedingly high doses. Thus, the LD50 was not able to be established for kratom. mitragynine exposures which varied widely from very low to very high levels. Recently, Papsun (2023) reviewed more than 5400 blood mitragynine postmortem kratom cases tested at NMS Labs over the last five years. Kratom identification in postmortem cases was 1.67-1.88% over the last 5 years. Mean and median blood mitragynine concentrations were 360 and 120 ng/mL, respectively, with a range of 5.4-11,000 ng/mL Most cases identified the presence of other drugs including fentanyl in 62%, methamphetamine 19%, cocaine 10% and others in 2022 cases. The authors concluded that "blood mitragynine concentrations of >1000 ng/mL are more often associated with severe adverse events, up to and including death." However, there was no conclusion as to what dose of kratom or mitragynine alone might be considered "lethal" or to carry a high risk of mortality. Although kratom related deaths are low when compared to its widespread use, consumers should be aware of the potential dangers of combining multiple prescribed and recreational drugs with kratom. Although the lethal dose in humans remains unknown, consumers should not take excessive kratom doses, should not consume kratom with other CNS-active drugs and should consider their personal medical conditions. Regulation with balanced evidence -based warnings is in the interest of personal and public health to minimize the risks of kratom without falsely equating it with "narcotics" or "opioids" and thereby discouraging its contribution to harm reduction. IIs kratom fueling the opioid overdose epidemic? The US has the world's most sophisticated and multi -pronged substance abuse and product safety monitoring network including the National Survey on Drug Use and Health (NSDUH), Monitoring the Future (MTF), Treatment Episodes Data Set, and the DEA's National Forensic Laboratory Information System (NFLIS). It also includes the Drug Abuse Warning Network (DAWN), which reported a variety of potential signals of emerging substance threats while kratom use was rapidly increasing from the 1990s through pre-2012 reports, as well as the "new" DAWN system that reported on 2021 data in its 2022 report. None of these systems, nor more than 20,000 comments to the DEA, suggested that kratom contributed to the opioid epidemic. Kratom was also never listed in DEA's annual National Drug Threat Assessment, though DEA routinely monitors kratom as a "chemical of concern." Despite over 10 years of monitoring, DEA has not listed kratom or mitragynine or 7OHMG as a national drug threat. Key scientific findings in the past five years: Multiple state of the art animal studies found that kratom has low abuse potential. For example, mitragynine produces weak rewarding effects as compared to morphine and heroin. The authors of this fact sheet urge that as a precaution, consumers should monitor their kratom consumption to reduce the risk of dependence development. Surveys indicate that some people can become dependent upon kratom; however, many of these people were using kratom to abstain from opioids and/or other substances. Disentangling prior substance use disorders from kratom use is not always clear. Most people who report kratom dependence or withdrawal state that it is more readily self -manageable than dependence and withdrawal from opioids and other drugs of abuse. Mitragynine treatment results in reduced opioid (e.g., morphine and heroin) drug seeking and self - administration in animal models assessing the potential effectiveness of drug use disorder reduction and cessation. These findings are consistent with human reports that kratom consumption reduces their opioid cravings and served as a path away from opioids. In animals made physically dependent on morphine, kratom pretreatment reduced morphine withdrawal symptoms in several models for evaluating efficacy in the treatment of withdrawal. 2023 UPDATES: How kratom works, that is, its mechanisms of action, is amongst the most active areas of research in the US and globally with new studies published in journals or presented at scientific meetings seemingly every month. Much of this progress is summarized in original research and review articles listed in the bibliography. A few key findings are included below. Whereas 7OHMG is often discussed as a potentially dangerous kratom constituent, studies indicate that it is present at very low and often not detectable levels in fresh kratom leaf material. Thus, it is better thought of as a mitragynine metabolite that gradually emerges in the bloodstream, likely contributing to some of the effects of kratom. Products that contain artificially high levels of 7OHMG (e.g., higher than 2% of the total alkaloid content) have likely been "spiked" with added 7OHMG. Regulatory oversight should prohibit such products. This is consistent with human reports that kratom consumption helps to manage opioid withdrawal and reduce opioid craving. Similarly, an intracranial brain self -stimulation study suggested low rewarding effects of kratom alkaloids as compared to drugs of abuse. Several national internet surveys found that kratom use was helpful in managing opioid withdrawal, reducing opioid cravings, and achieving abstinence from opioids. None of the national surveys relied upon by the FDA, Centers for Disease Control (CDC), NIDA, and DEA to determine if a substance poses an abuse -related threat to public health suggested that kratom poses a known or imminent risk to public health. Consistent with this, the DEA never listed kratom as a threat to public health in its annual National Drug Threat Assessment reports."' Safety studies in several animal species demonstrated that even at extraordinarily high doses, mitragynine and kratom produced little evidence of respiratory depression or life - threatening effects in contrast to opioids such as morphine and oxycodone which produced substantial dose related decreases in respiration. Whereas 2% is the performance standard used presently in some states, it would seem ideal for FDA to develop an evidence -based standard that might be somewhat higher or lower, and with guidance for accepted testing methods. Whereas mitragynine is the primary or sole alkaloid present in many marketed kratom products, it increasingly appears likely that a variety of other naturally occurring alkaloids contribute to the effects ascribed to kratom. Although kratom use persists in the US with several million consumers estimated, clear signals of substantial public health risk remain lacking, while the preponderance of evidence suggests that use of naturally derived kratom products is more typically associated with perceived health benefits. GENERAL CONCLUSION: The rapid progress in understanding the risks and benefits of kratom and its potential for therapeutic use and public health benefits over the past decade is a tribute to visionary funding from NIH and other organizations in the US and globally, as well as the dedication and care of hundreds of researchers worldwide. There clearly seems to be adequate scientific evidence to not only justify why regulation is warranted but also to guide regulatory efforts. For any regulation of food, dietary ingredients and pharmaceuticals, regulations need to be considered as an evolutionary process guided by emerging scientific evidence including laboratory and clinical studies, as well as real world surveillance to understand trends, patterns and emerging risks and benefits to health and well- being. Thus, the conclusion that more research is warranted should not be used as an excuse to delay regulatory implementation but rather a vital part of relevant and effective regulatory implementation and evolution. Through Pinney Associates, Drs. Henningfield and Huestis provide scientific and advising on new medicines, dietary supplements, cannabinoids, and tobacco/nicotine products for FDA regulation. This paid work includes le ding the development and drafting of this kratom science facts summary for the American Kratom Association. Dr. Grundmann is a member of the advisory board of the Kratom Vendors Association and received an honorarium from the American Kratom Foundation for participation in a scientific discussion forum about kratom dependence. Dr. Garcia-Rgmeu is a paid scientific advisor to ETHA Natural Botanicals and received a speaking honorarium from he American Kratom Foundation. Expert evaluations of kratom policy and regulation and risks & public health United Nations Commission on Narcotic Drugs, WHO Expert Committee on Drug Dependence (2021). Implementation of the international drug control treaties: changes in the scope of control of substances Summary of assessments, findings and recommendations of the 44th World Health Organization's (WHO) Expert Committee on Drug Dependence (ECDD), 11-15 October 2021: Kratom, mitragynine, 7-hydroxymitragynine. -\ hops.,IA w.unodc.org/documents/commissions/CND/CND Sessions/CND 64Reconvened/ECN72021_C R RP12_V2108992.pdf. Assistant Secretary of Health Dr. Brett P. Giroir, Admiral (August 16, 2018). Letter from the Assistant Secretary of Health to the Administrator of the Drug Enforcement Administration to rescind previous support to permanently place mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled Substances Act 2018 - \ Available from: https://iimages.go02.informamarkets.com/Web/Informa02l''l7b548e6d56-2ea4-4da4-9404- R 0348b56e9a88%7d dhilIon-8.16.2018-msponse-letter-from-ash4adm-gimir.pol: OGershman K, Timm K, Frank M, Lampi L, Melamed J, Gerona R, Monte AA. Deaths in Colorado Attributed to Kratom. f* N Engl J Med. 2019 Jan 3;380(1):97-98. O Henningfield JE, Rodricks JV, Magnuson AM, Huestis MA. Respiratory effects of oral mitragynine and oxycodone in a rodent model. MPsychopharmacology 2022 Dec,,239(12):3793-3804. r Olsen EO, O'Donnell J, Mattson CL, Schier JG, Wilson N. Notes from the Field: Unintentional Drug Overdose Deaths with Kratom Detected - 27 States, July 2016-December 2017. MMMWR Mort, Mortal My Rep. 2019 Apr 1266(14):326-327. OPapsun D, Schroeder W, Brower J, Logan B. Forensic Implications of Kratom: Kratom Toxicity, Correlation with Mitragynine Concentrations, and Polypharmacy. CurrAddict Rep 10, 272-281 (2023). Note: This is a summary of the WHO Expert Committee on Drug Dependence pre -review of kratom concluding that the evidence does not support initiation of a full review of kratom for international drug scheduling considering its effects, safety, abuse related- risks and public health factors. This formal DHHS scheduling rescission letter summarizes review of the evidence for FDA's 2017 recommendation to schedule kratom and concluded that FDA did not provide sufficient evidence to support scheduling, and also failed to consider the adverse public health consequences of Scheduling and thereby banning legal consumer access to kratom. An important investigation of autopsy reports listing kratom only as cause of death and the importance of comprehensive toxicology to identify the presence of other toxic drugs contributing to the death. The range of mitragynine concentrations in kratom-related deaths includes low levels far below those reported in controlled kratom administration studies. An exceedingly high dose of 400 mg/kg oral mitragynine did not significantly depress respiration or produce life - threatening effects in rats. The LD50 was not established for kratom. However, 60 and 150 mg/kg oral oxycodone significantly depressed oxygen saturation and sedated the animals resulting in two deaths. Center for Disease scientists analyzed data from the State Unintentional Drug Overdose Reporting System finding that although kratom identifications in postmortem autopsy cases only represented 0.56% of overdoses, it was reported as cause of death (kratom-involved) in 59.9% of cases. Potent opioids were also identified in these kratom cases, 65.1 % fentanyl, 32.9% heroin and 19.7% prescription opioids After reviewing mitragynine concentrations in more than 5400 blood postmortem kratom cases over the last five years, mitragynine was identified in 1.67-1.88% cases, with a wide range of concentrations (5.4-11, 000 nglniQ. Most cases identified the presence of other drugs including fentanyl in 62%, methamphetamine 19%, cocaine 10% and others. The authors concluded that "blood mitragynine concentrations of>1000 ng/mL are more often associated with severe adverse events, up to and including death."Although kratom related deaths are low when compared to its widespread use, consumers should be aware of the potential dangers of combining multiple prescribed and recreational drugs with kratom. OProzialeck, W., Avery, B., Boyer, E., Grundmann, O., Henningfield, J., Krueger A., McMahon, L., McCurdy, C., Swogger, M., Veltri, C., and Singh, D. (2019). Kratom Policy: The challenge of balancing therapeutic potential with public safety. MInternational Journal of Drug Policy, 70:70-77. OGrundmann O, Garcia-Romeu A, McCurdy CR, Sharma A, Smith KE, Swogger MT, Weiss ST (2023). Not all kratom is equal: The important distinction between native leaf and extract products. f* Addiction. 2023 Oct 9. doi: 10. 1111/add. 16366. Epub ahead of print. PMID: 37814405. Swogger MT, Smith KE, Garcia-Romeu A, Grundmann O, Veltri CA, Henningfield J, Busch LY (2022) Understanding kratom use: a guide for healthcare providers. Front Phannacol 13:801855. Henningfield JE, Grundmann O, Babin JK, Fant RV, DW, Cone EJ (2019) Risk of death associated with kratom use compared to opioids. Prev Mod. 128,105851. Henningfield JE, Wang DW, Huestis MA (2022) Kratom abuse potential 2021: an updated eight factor analysis. Front Pharmacol 12:775073. Note: Leading kratom researchers discuss policy implications of state-of-the-art knowledge related to kratom's effects, uses, risks, and real -world public health benefits and risks. This article addresses the fact that some manufactured extracts have high concentrations of mitragynine and other substances and do not include labeling that describes the concentrations, total content, or recommended serving sizes and the need for national regulation of such. Although there are no FDA approved uses for kratom, which is the case for most dietary supplements, this expert opinion article provides practical information for consideration by health care professionals whose patients are consuming kratom. This article compared estimates from FDA of deaths associated with kratom consumption in comparison with deaths associated with nonmedical opioid use concluding that the risk of death associated with kratom use is at least 1,000 times less than for opioids. This article is a published version of an assessment of kratom abuse potential according to the 8-factor analysis required for permanent scheduling by the Controlled Substances Act. It concludes that on the basis of all factors, including decades of surveillance in the US, and decades more globally, kratom does not warrant scheduling and, in fact, that scheduling kratom would carry adverse public health consequences. This is consistent with the position of the WHO Expert Committee on Drug Dependence and the DHHS review led by Assistant Secretary Giroir. Whereas there are several surveys that provide estimates of how many people use kratom with estimates ranging from about 2 to more than 15 million, those surveys provide no information about why people use kratom, or the consequence of their kratom use (See Henningfield JE, Grundmitn O, Garcia-Romeu A, Swogger MT. We Need Better Estimates of Kratom Use Prevalence. Am J Prev Med. 2022;62(1):132-133). The following surveys are focused , Specifically, these surveys show that although there is some on why people use kratom and recreational use of kratom, most people use for reasons provide insights as to the risks an related to health and well-being including as approaches to benefits of kratom onsumption. self -manage opioid and other drug withdrawal and to reduce and discontinue opioid and other addictive drug use. Coe MA, Pillitteri A, Sembower MA, Gerlach KK, Henningfield JE. Kratom as a substitute for opioids: Results from an online survey 0 Drug Alcohol Depend.2019;202:24-32. OGarcia-Romeu A, Cox DJ, Smith KE, Dunn KE, Griffiths RR. Kratom (Mitragyna speciosa): User demographics, use patterns, and implications for the opioid epidemic. 0 Drug Alcohol Depend.2020;208:107849. OGrundmann O. 0 Smith KE, Rogers JM, Dunn KE, et al. Patterns of Kratom use and health impact in the US -Results from Searching for a Signal: Self -Reported Kratom Dose -Effect an online survey. Relationships Among a Sample of US Adults With Regular Kratom M Drug Alcohol Depend.2017;176:63-70. Use Histories. O Smith KE, Rogers JM, Schriefer D, Grundmann O. Therapeutic benefit with caveats?: Analyzing social media data to understand the complexities of kratom use. 0 Drug Alcohol Depend. 2021;226:108879. O Exploring the self -reported motivations of kratom ( Mitragyna speciosa Korth.) use: a cross -sectional investigation A Grundmann et al. 2022 (PMID: 35389321) (Feldman et al., 2023; Smith et al., 2023 0 Front Pharmacol. 2022;13:765917. Swogger MT, Walsh Z. Kratom use and mental health: A systematic review. 0 Drug Alcohol Depend. 2018;183:134-40. Oliver Grundmann 1 2, Charles A Veltri 2, Diana Morcos 2, David Knightes 3rd 2, Kirsten E Smith 3, Darshan Singh 4, Ornella Corazza 5, Eduardo Cinosi 5 6, Giovanni Martinotti 5 7, Zach Walsh 8, Marc T Swogger 9Smith et al., 2023; and a few in 2022 Behnood-Rod A, Chellian R, Wilson R, Hiranita T, Sharma A, Leon F, et al. Evaluation of the rewarding effects of mitragynine and 7-hydroxymitragynine in an intracranial self -stimulation procedure in male and female rats. 0 Drug Alcohol Depend. 2020;215:108235. Hassan R, Pike See C, Sreenivasan S, Mansor SM, Muller CP, Hassan Z. Mitragynine attenuates morphine withdrawal effects in rats -a comparison with methadone and buprenorphine. Front Psychiatry.2020;11:411. OHemby SE, McIntosh S, Leon F, Cutler SJ, 0 Yue K, Kopajtic TA, Katz JL. McCurdy CR. Abuse liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-hydroxymitragynine. Addict Biol. 2019;24(5):874-85. Abuse liability of mitragynine assessed with a self -administration procedure in rats. Psychopharmacology (Berl). 2018,,235(10):2823-9. A Wilson LL, Harris HM, Eans SO, Brice-Tutt AC, Cirino TJ, Stacy HM, et al Lyophilized kratom tea as a therapeutic option for opioid dependence. M Drug Alcohol Depend. 2020;216:108310. Note: The following studies are representative of several dozen other studies published since 2018 that help understand the effects, and potential benefits and risks of kratom's constituents including mitragynine. At kratom doses far higher than those consumed b that kratom does not carry risks but rather that its overall risks appear much lower than those associated with opioids. Balanced regulation could help consumers minimize the risks of kratom use by banning medical claims, providing accurate labeling and warning labels, as is being implemented in states that passed kratom consumer protection act laws. Avery BA, Boddu SP, Sharma A, Furr EB, Leon F, Cutler SJ, et al. Comparative pharmacokinetics of mitragynine after oral administration of Mitragyna speciosa (kratom) leaf extracts in rats Planta Med. 2019;85(4):340-6. Hill R, Kruegel AC, Javitch JA, Lane JR, Canals M. (2022) The respiratory depressant effects of mitragynine are limited by its conversion to 7-01-1 mitragynine. Br J Pharmacol. 179(14):3875-3885. I Macko E, Weisbach JA, Douglas B (1972) Some observations on the pharmacology of mitragynine [in cats, dogs and monkeys]. a Arch Int Pham,_ 198(1):145. Chakraborty S, DiBerto JF, Faouzi A, Bernhard SM, Gutridge AM, Ramsey S, et al. A novel mitragynine analog with low -efficacy mu opioid receptor agonism displays antinociception with attenuated adverse effects. J Med Chem. 2021;64(18):13873-92. Kruegel AC, Grundmann O. The medicinal chemistry and neuropharmacology of kratom: A preliminary discussion of a promising medicinal plant and analysis of its potential for abuse. Neuropharmacology. 2018; 134(Pt A): 108-20. Maxwell EA, King TI, Kamble SH, Raju KSR, Berthold EC, Leon F, et al. Pharmacokinetics and safety of mitragynine in beagle dogs. Planta Med 2020;86(17):1278-85. i a � RMA.� 2022, March 25. Kratom. Retrieved from https://nida.nih.gov/research-topicslkratom on December 5, 2023 Obeng S, Wilkerson JL, Leon F, Reeves ME, N. Restrepo LF, Gamez-Jimenez LR, et al. Pharmacological comparison of mitragynine and 7- hydroxymitragynine: In vitro affinity and efficacy for mu-opioid receptor and opioid-like behavioral effects in rats. 0 J Pharmacol Exp Ther. 2021;376(3):410-27. Vicknasingam B, Chooi WT, Rahim AA, Ramachandram D, Singh D, Ramanathan S, et al Kratom and pain tolerance: A randomized, placebo -controlled, double-blind study. Yale J Biol Med. 2020;93(2):229-38. r McCurdy C, Grundmann O, McLaughlin Obeng S, Kamble SH, Reeves ME, Restrepo LF, Patel A, Behnke M, Chear NJ, Ramanathan S, Sharma A, Leon F, Hiranita T, Avery BA, McMahon LR, McCurdy CR. Investigation of the Adrenergic and Opioid Binding Affinities, Metabolic Stability, Plasma Protein Binding Properties, and Functional Effects of Selected Indole-Based Kratom Alkaloids. 0 J Mad Chem. 2020 Jan 9;63(1):433-439. 1% Sharma A, McCurdy CR. Assessing the therapeutic potential and toxicity of Mitragyna speciosa in opioid use disorder. f* Expert Opin Drug Metab Toxicol. 2021;17(3):255-7. Chakraborty S, DiBerto JF, Faouzi A, Bernhard, SM, Guttridge, AM, Ramsey, S et al. .(2021). A Novel Mitragynine Analog with Low -Efficacy Mu Opioid Receptor Agonism Displays Antinociception with Attenuated Adverse Effects. e J Med Chem. 2021;64(18):13873-13892. J (2020) Kratom Resources. Department of Pharmacodynamics, College of Pharmacy, University of Florida. https://pd.pharmacy.uff.edu/research/kratoml.. Accessed 8 March 2022. Note: this is a living and evolving repository of factual scientific information that may be useful to policy makers, regulators, consumers, and other researchers. It is an example of what would ideally be provided by NIH and FDA. r Neither the US Food Drug and Cosmetic Act, nor the US CSA or the international drug control treaties define "therapeutic use" as being approved as drugs by FDA or the equivalent regulatory agencies in other countries. However that has become the de facto standard of the FDA, which therefore ignores self -reported beneficial use by dietary supplement consumers and states that they have no recognized therapeutic use, and thus, widespread use of kratom to stay off opioids was ignored as a benefit. The authors of this science update and the American Kratom Association agree that specific health claims should not be made by kratom marketers without supporting evidence, but neither should policy makers simply dismiss the benefits of kratom and the risks of removing licit kratom by millions of kratom consumers. ®Contributing to the misunderstanding that kratom carries opioid-like risks of overdose and addiction is a misunderstanding of potency and strength. Strength refers to the maximum effect that a substance can produce, whereas potency refers to how much of the substance it takes to produce a given effect. Thus, alcohol is strong and actually results in approximately 2,000 overdose deaths annually in the US, however, it is relatively low in potency among central nervous system active substances and requires the equivalent rapid consumption of a quart or more of high percentage (proof) alcohol to produce death, though for young people it may take much less as suggested by fraternity hazing related deaths every year in the US. At the other extreme is fentanyl which can produce extremely strong euphoriant effects in humans, reinforcing effects in animals, and lethal respiratory depressant effects at very low doses of just a few mg. Kratom's primary active alkaloid, mitragynine is both relatively weak and low in potency with respect to respiration as compared to morphine. In fact, it is a partial agonist with respect to respiratory depression, meaning that its maximal effects at all tested doses do not produce lethal respiratory depression. The mitragynine metabolite 7-hydroxymitragynine is more potent than morphine on the guinea pig ileum muscle twitching test but that test is not necessarily relevant to lethality, and 7-hydroxymitragynine, also appears to be a partial agonist with respect to its respiratory effects. ®DEA has included kratom on its list of "drugs and chemicals of concern", for the past decade, first listing it following reports of overdose deaths in Sweden among consumers of a kratom product that was later concluded to have been adulterated with lethal doses of O-desmethyltramadol. However, as mentioned in this science update, DEA never listed kratom as a threat to public health in its annual National Drug Threat Assessment reports. In fact, it has not listed kratom in its annual National Forensic Laboratory Reports since 2016, apparently, because the reports have remained low and not at the "threshold for reporting." Whether and when DEA will remove kratom or kratom alkaloids from its drugs and chemicals of concern list is not clear since researchers agree that kratom use and epidemiology should continue to be monitored, but unfortunately, this listing implies a higher level of concern than has been expressed by any other DEA action since it withdrew its scheduling proposal in 2016. • The FDA announced on January 16, 2024, it will accept proposalsto conduct a Human Abuse Potential ("HAP") study to assess the potential severity of a kratom dependency or addiction liability The HAP study is authorized only because the dose finding study showed kratom can be safely ingested. An FDA scientist reported on some of the results of the dose finding study at the Third Annual Kratom Symposium on February 14-15, 2024. Researchers report that some of the policy staff at the FDA were "profoundly disappointed" at the lack of adverse events that occurred among human participants in the dose finding study, where the ascending doses gotto 12 grams of kratom material beforejust2 of the participants experienced some nausea. That level of kratom consumption is extraordinarily high among current kratom consumers. • w A111111111111111111111WL.Mi J- POLICY BRIEF It is reported that the scientists at FDA accepted the safety data for its evidentiaryvaIue and are now preparing to make a public presentation on the results ofthe dose finding study at a scientific conference in the fall of 2024. That dose finding study data cleared the way for the HAP study to be advertised and that is expected to be completed within 2 years. It is important to note thatthe dose finding study had to demonstrate kratom can be safely consumed before the HAP study could ethically be advertised. Kratom researchers are excited that the next level of studies on the safety and addiction liability of kratom extract products, and safe consumption levels can be identified, and the limits on kratom plant constituents in a kratom product before it is deemed to be adulterated. Those needed dose finding and HAP studies for kratom extract products will take several years after the current HAP study is completed. i. https://grants.gov/search-results-detail/351644 ii. https:Hpharmacy.uf.edu/third-international-kratom-symposium/ iii. https://www.fda.gov/files/drugs/published/Botanical-Drug-Development—Guidance-for-Industry.pdf 9 The American Kratom Association 1 13575 Heathcote Boulevard, Suite 320 1 Gainesville, VA 20155 www.americankratom.org -- www.kratomanswers.org UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA UNITED STATES OF AMERICA, Plaintiff, ►v NINE2FIVE, LLC ( I ), SEBASTIAN GUTHERY (2), Subject: Defendants. FW: Guthery Case No. 3:23-cr-00I79-TWR MOTION FOR ISSUANCE OF SUBPOENA DIRECTING THE FDA TO PRODUCE DOCUMENTS FOR INSPECTION IN ADVANCE OF THE EVIDENTIARY HEARING ON JANUARY 11, 2424 EXH I BIT 6 From: Pierson, Melanie (USACAS) <Melanie.Pierson@usdoi.gov> Sent: Friday, December 1, 2023 9:40 AM To: Young, Andrew <Andrew.Young@btlaw.com> Cc: Orabona, Joseph (USACAS) <Joseph.Orabona@usdoi.gov> Subject: [EXTERNAL] Guthery Caution: This email originated from outside the Firm. We have been in contact with representatives of the FDA regarding the upcoming sentencing hearing regarding the dangers of kratom. They have refused to provide us with witnesses or documents to support our position, as well as witnesses and documents that might be inconsistent with our position. The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous. We are prepared to withdraw our sentencing memorandum and refile, using supporting materials from independent experts and not the FDA, as we do not believe that the FDA is a part of the prosecution team in this case. If you disagree, please let us know immediately so we can file a motion with the court to resolve this issue in advance of the sentencing hearing. Respectfully, AUSA Melanie Pierson Filed December 6, 2023 Why does the FDA claim kratom is unsafe for consumers? The FDA has a long-standing bias against any dietary ingredient, botanical supplement, or dietary supplement that is not a chemical formulation subject to regulatory approval as a new drug. In 1994, Congress passed the Dietary Supplement Health and Education Act (DHEA) to reign in the FDA's overregulation of dietary supplements FDA wanted banned on the premise they were highly addictive, being used to self -medicate without physician supervision, or were so poorly formulated these products posed a threat to public health requiring them to be banned. Today, FDA maintains the same three common objections about kratom, i.e., kratom is unsafe, is highly addictive, and has no approved medical use — and people are using it to self -medicate to withdraw from opioid addictions. Accordingly, FDA has made three specific attempts to have kratom's constituents, mitragynine ("MG") and 7- hydroxymitragynine (" 7-HMG"), as Schedule I substances. Based on current science, leading public health officials have reviewed the current evidence and data on kratom and vigorously disagree with the FDA's assessment of kratom's addiction and safety profile. All three of the FDA's recommendations for scheduling have been rejected by the Drug Enforcement Administration; the U.S. Department of Health and Human Services (HHS); and the Expert Committee on Drug Dependence (ECDD) for the U.N. Commission on Narcotic Drugs. AMERICAN KRATOM x ASSOCIATION Key Kratom Questions And Answers 12023 The FDA claims kratom should be classified as a Schedule I substance, so why is kratom not scheduled today at the federal level? The short answer is because the FDA is wrong on the science, and wrong on the policy. Other federal and international agencies have carefully evaluated the October 13, 2016: The DEA withdrew the Notice of Intent recommending the temporaryscheduling of kratom and requested a full 8- Factor Analysis from the FDA. FDA's claims and they find they lack sufficient evidence to support the FDA claims. December 1, 2021: The Expert Comm ittee on Drug Dependence atthe World Health Organization and the U.S. Commission of Narcotic Drugs, comprised of 12 international experts on substance safety and addiction, unanimously concluded thatthere was insufficient evidence to recommend a critical international scheduling review of kratom. August 16, 2018: H HS Assistant Secretary for Health, Brett Giroir, M.D., formally withdrew the FDA scheduling recommendation forkratom that had been submitted to the DEA and called out the FDA for "disappointinglypoor evidence & data and a failure to considerthe overall public health." December29, 2022: President Biden signs the FY23 Omnibus with kratom report language commending NIDA for funding studies on kratom that"may provide help for some Americans struggling with addictions, given its analgesicand less addictive properties as compared to opioids." March 16, 2022: Letter from HHS Secretary Becerra acknowledging "knowledge gaps" on kratom and that "kratom-involved overdose deaths have occurred after use of adulterated kratom products ortaking kratom with other substances." Is it true there is no approved medical use for kratom? That claim is true, but it is also true for tens of thousands of foods, dietary ingredients, botanical supplements, and dietary supplements that are available to consumers in the U.S., many of which are regularly used to self - medicate by consumers to maintain their health and well-being. Federal law provides adequate authority for the FDA to prosecute any vendors who make illegal therapeutic claims to induce consumers to buy their products for therapeutic uses. In response, the AKA has submitted more than 70 documented cases of kratom vendors using illegal marketing claims on some therapeutic benefits they claim are associated with kratom consumption. Despite having sufficient legal authority to protect consumers from such illegal marketing schemes, the FDA has not initiated a single prosecution against any of those violators. 0 �,4MERIG4N KRATOM ASSOCIATION Key Kratom Questions And Answers 12023 How many states have enacted the Kratom Consumer Protection Act? As of today, 11 states have passed similarversions of the KCPA: Utah, Georgia, Arizona, Nevada, Oregon, Colorado, Oklahoma, West Virginia, Virginia, Texas, and Florida. Additional states currently deliberating on KCPAs are Kansas, Illinois, Indiana, Michigan, Minnesota, Tennessee, Ohio, Pennsylvania, New Jersey, New York, Florida, North Carolina, Arkansas, Louisiana, South Carolina, Vermont, Wisconsin, and Rhode Island. M!" k! 0 Passed versions of the KCPA Deliberating on KCPAs What is the status of the six states that banned kratom at the request of the FDA? The FDA has vigorously engaged in a disinformation campaign against kratom for more than a decade. Six states did enact bans from 2021 to 2017, all in good faith, and all on the premise the FDA information was accurate: Alabama, Arkansas, Wisconsin, Indiana, Vermont, and Rhode Island. Now those states are starting to push back against the FDA disinformation, and most are actively working to correct the mistakes made in response to the requests by the FDA. Vermont followed the FDA's recommendation to schedule kratom in 2016. Pursuant to a petition filed with the Vermont Department of Health to remove mitragynine and 7- if hydroxymitragynine from the Regulated Drug Rule, the Department granted the petition submitted by the American Kratom Association ("AKA") on March 1, 2023, and will commence rulemaking shortly to complete that process, stating as follows: "This email it to apprise you that the Department is granting your petition to remove mitragynine and 7- hydroxymitragynine form the Regulated Drug Rule." ;ram" AMERICAN KRATOM A ,.P ASSOCIATION Key Kratom Questions And Answers I June 2023 Wisconsin is another state that banned kratom on the recommendation of the FDA, and the Wisconsin Controlled Substances Board ("CSB") received a report from Dr. Chris Cunningham, Associate Professor of Pharmaceutical Sciences at Concordia University Wisconsin, with the following conclusion: diBased on our review of the available literature, we conclude that regulation of M. speciosa in Wisconsin as a schedule-1 substance is not justified at this time. We base this conclusion, in part, on the scientific evidence demonstrating that M. speciosa and its chemical constituents have lower potential for overdose and abuse relative to other agents that are not scheduled in this way. We believe that controlling M. speciosa and its chemical constituents under schedule-1 harms public health and stifles much -needed research into its therapeutic and toxic properties. 99 In response, members of the Wisconsin Legislature asked the CSB for an assessment of whether kratom's constituents meet the statutory requirements for scheduling under the 8-factor analysis. On March 10, 2023, the CSB approved a motion to affirm mitragynine and 7 hydroxymitragynine do not meet the required 8-factors for scheduling under Wisconsin law. I` The Interim Director of the Rhode Island Department of Health, Utpala Bandy, M.D., has acknowledged that kratom does not meet the criteria for scheduling set forth in Rhode Island statutes. In Indiana, the House of Representatives took the first step to remove the kratom ban and A I enact the Kratom Consumer Protection Act in a vote of 54-30 on February 21. The bill has now been transmitted to the Senate for action. Is the FDA claim true that kratom is an opioid? No, kratom is not an opioid by plant genetics, by chemical structure, or by legal definition. While some naturally occurring substances in kratom act on opioid receptors, kratom is not a prototypical opioid based on its chemical structure, botanical origins, or law — nationally or internationally. Like many natural products it has diverse effects and mechanisms of action that contribute to these effects and the reasons people use kratom. Properly characterized as "partial agonists" some kratom constituents bind to opioid receptors and relieve pain whereas others do not. Unlike opioids which sedate and can impair mental functioning, kratom is used by many people in place of coffee for its alerting, mental focusing, and occupational performance enhancing effects. Animal and human studies, as well as neuropharmacology mechanisms of action studies, show that kratom does not carry the substantial opioid-like risks of deadly respiratory depression or powerfully addictive euphoria. A misunderstanding of one of kratom's self -reported beneficial uses, recognized by researchers and NIDA, providing relief of opioid withdrawal, is sometimes interpreted as evidence that it must be an opioid. In fact, the nonopioid adrenergic blocking drugs developed for treating high blood pressure, clonidine and lofexidine, were prescribed for decades to treat opioid withdrawal. FDA approved lofexidine (Lucemyra) for treating opioid withdrawal in 2018. Mitragynine and other kratom constituents also produce adrenergic effects. AMERICAN Ar KRATOM ASSOCIATION Is the FDA claim true that kratom is dangerously addictive? No, the FDA is completely wrong on this point. 1 significant difference between addiction and dependent there is a similar significant difference between a dangi addiction and a socially acceptable benign addiction or dependency. Caffeine is the most widely used drug in t and it has an addiction profile that is characterized by and the FDA, as having an acceptable addiction profile The available data suggest relatively low abuse potential as compared to morphine - like opioids, stimulants, and other drugs of abuse that demonstrate robust rewarding effects across all such abuse potential models. Similarly, MG's potential to produce physical dependence and withdrawal appears relatively low, but not absent, as compared to opioids in animal models. These findings are generally consistent with human reports that MG has a relatively low abuse and withdrawal potential as compared to recreationally used opioids but can reduce opioid self -administration and withdrawal. Key Kratom Questions And Answers I June 2023 NIDA has conducted two specific animal studies on the addiction liability of kratom, with the following results: • Abuse liability of mitragynine assessed with a self - administration procedure in rats. "These results suggest a limited abuse liability of mitragynine and potential for mitragynine treatment to specifically reduce opioid abuse. With the current prevalence of opioid abuse and misuse, it appears currently that mitragynine is deserving of more extensive exploration for its development or that of an analog as a medical treatment for opioid abuse." (See https://pubmed.ncbi.nlm.nih.Qov/30039246/ • Abuse liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-hydroxymitragynine. "The present findings indicate that MG does not have abuse potential and reduces morphine intake, desired characteristics of candidate pharmacotherapies for opiate addiction and withdrawal, whereas 7-HMG should be considered a kratom constituent with high abuse potential that may also increase the intake of other opiates." (See https://pubmed.ncbi.nlm.nih.gov/29949228L) 0 �,4MERIG4N KRATOM ASSOCIATION Key Kratom Questions And Answers I June 2023 Is the FDA claim true that kratom is a deadly drug that people are dying from? No, this FDA claim about deaths associated with kratom has been reviewed byexperts and found to be untrue. It is well understood that kratom's respiratory effects are not like those of morphine -like opioids and peer -reviewed published studies since 2018 support the conclusion that kratom is not simply weaker than opioids with respect to respiratory depression, kratom does not cause respiratory suppression and associated overdose death. Specifically, mitragynine and other alkaloids in kratom act as partial agonists at opioid receptors, meaning that their maximal effects reach a ceiling beyond which higher doses produce little additional effect. This was demonstrated in se\eral animal species (including cats, dogs, mice, and rats) with mitragynine doses increased to levels far beyond what is or can be consumed by even high intake chronic kratom consumers. The most recent study employed a sophisticated rodent model developed by FDA to compare a broad range of mitragynine doses to therapeutic and toxic oxycodone doses across blood gases and other parameters. Whereas oxycodone produced the signature dose - related plummeting blood oxygen levels and deaths, mitragynine produced no evidence of respiratory depression at any dose, and no life -threatening effects. Why does the DEA list kratom as a "Drug of Concern"? The DEA has appropriately listed kratom as a "Drug of Concern" based on the conflicting reports made by the FDA, particularly with the deliberate adulteration and mislabeling of kratom products by some unscrupulous vendors in the kratom marketplace. Common adulterants include fentanyl, heroin, buprenorphine, and morphine. The DEA simply maintains sunteillance of kratom to review reports of ad\terse events to potentially identify and interdict such adulteration with dangerous substances. Why does the FDA have two im port alerts on kratom? The FDA has used import alerts to create a de -facto ban on kratom since they cannot meet the requirements for scheduling under the Controlled Substances Act (CSA). While clearly an abuse of its regulatory authority, the premise of the import alerts is based entirely on the contrived and wholly inaccurate addiction and safety profile promoted by the FDA itself. 0 �,4MERIG4N KRATOM ASSOCIATION Can you overdose on kratom itself? The overall risk for kratom overdose appears at least 1,000 times lower for kratom as compared to opioids. There were no deaths in which either the FDA or CDC confirmed as appropriately categorized as due to kratom consumption. Kratom consumers should not assume that kratom is without risk, but like many common consumer products, responsible use is a key safety factor. The CDC did not list kratom as a cause of any of the more than 108,000 drug overdose deaths in 2021, or in any other year of which we are aware. In contrast, opioids were concluded by the CDC and NIDA to account for more than 80,000 overdose deaths in 2021. Overdose is possible with many readily available consumer substances, including caffeine, but kratom's most common side -effect, transient stomach upset and nausea, also limits intake and is Key Kratom Questions And Answers I June 2023 discomforting but not seriously harmful. In February 2018, after announcing that kratom carried opioid-like death risk, the FDA noted that only one of 43 deaths occurring in kratom consumers did not involve other respiratory depressing substances. Further imiestigation found that the final cause was a motor vehicle fatality involving a kratom consumer. In a review of the 44t" death reported by the FDA to have been caused by kratom ingestion, when the autopsy report was obtained the actual cause of death was two gunshot wounds to the chest that occurred during a drug sting operation by law enforcement. The decedent had incidentally consumed a kratom tea on the morning he was shot. NIDA, FDA, HHS, and ECDD all have concluded that most kratom-associated deaths involved other substances. What is the profile of the typical kratom consumer? According to surveys in the US, most consumers report are White adults, aged 35-55, with jobs and health care insurance, who report that their consumption is primarilyfor health and wellbeing. This includes consumption as an alternative to caffeinated products for alertness and increased focus, for the self -management of pain, and to improve mood. Many consumers state that kratom worked better for them, had fewer side -effects than the FDA -approved medicines that had been taken, and/or that they preferred natural products. A smaller but especially important fraction of consumers are people who consider kratom as a "life -line" or a path away from opioids. They use kratom to manage opioid withdrawal and reduce or eliminate opioid use. 0 �,4MERIG4N KRATOM ASSOCIATION Key Kratom Questions And Answers I June 2023 What form do kratom products use in the marketplace? It is well known that kratom has a bitter taste, which accounts for why pure, unadulterated kratom products are not attractive to minors. Kratom is sold in powder form, which is typically brewed into a tea by adding hot water — although some consumers consume the powder orally; in capsule or pill forms that bypass the bitter taste; and in liquids much like a five -hour energy drink. Kratom critics frequently point to kratom products being sold in convenience stores or gas stations as evidence of their harm. To the contrary, the most important protection for consumers is to make certain that every kratom product offered meets the manufacturing criteria for its content; is free from dangerous adulterants; is labeled properly; and is not sold to minors. Some kratom products are "extracted" to (1) purify to remove any microbial contaminants; and (2) to standardize the alkaloid content of each serving size recommended for use of those products. Like any other consumer product similarly extracted, including coffee, plants and fruits, and essential oils, these extracts must use approved FDA food -grade solvents to complete the extraction process safely. Many kratom critics claim all liquid kratom products are extracts. That is not true. Extracted kratom products are across all product forms, and the key to their safety is the use of safe extraction solvents and directions on appropriate serving sizes. What does recent science reveal about kratom? Since 2018, there have been more than 100 new published research articles on kratom. While there are public references to that research, a recent presentation on new science on kratom was made at the UN Commission on Narcotic Drugs Conference in Vienna on March 16, 2023. Here are links to video of presentations made by 4 of the world's leading experts on kratom at that conference: Entire presentation (about 50 minutes long): https://youtu.be/ortAWZAaxGo Individual segments from each presenter (each is about 10 minutes long): Dr. Marilyn Huestis, former NIDA official Dr. Jack Henningfield, Pinney Associates now with Thomas Jefferson University: 0 and Johns Hopkins University: https://youtu.be/SbQtzs4uphQ https://youtu.be/oZ-i9-nFF8el Dr. Kirsten Smith, NIDA: Dr. Chris McCurdy, University of Florida: https://youtu.be/aLS-ZbV5klk 0 https://youtu.be/KBR&RcydoF 0 �,4MERIG4N KRATOM ASSOCIATION Summary Key Kratom Questions And Answers I June 2023 Kratom is safely used by consumers for a \rariety of purposes, chief of which is for its energy boost and increased focus effects, typically as a replacement for a cup of coffee. Research indicates kratom can act as = a pain reliever for acute and chronic pain and potentially even treat opioid withdrawal. The National Institute on Drug Abuse (NIDA) has currently funded more than $30 million in kratom research studies,' including several grants totaling $15 million at the University of Florida. The U.S. Congress issued Report Language in each of the last four annual budgets calling for further research f to expand studies on kratom. Pure kratom products, when used responsibly, are safe. Studies conducted by the NIDA confirm kratom has no significant addiction liability. Any deaths allegedly associated with kratom are due to adulterated kratom, polydrug use, or underlying health conditions. To protect American consumers, suitable public policy kratom solutions require appropriate regulation. 'I For additional information go to hftp://www.kratomanswers.org. AMERICAN KRATOM ASSOCIATION POLICY BRIEF February 2024 The FDA has repeatedly made claims overthe past 12 yearsthat kratom is a dangerous substance that should be classified as a Schedule I substance underthe federal Controlled Substances Act ("CSA"). Yet, when called by a Federal Judge to present witnesses and testimony under oath in a case in the Southern District of California at a Hearing on February 8, 2024, on whether kratom is dangerous, the FDA refused to attend the Hearing or even provide under oath any documents or testimonyto the Court) The explanation provided bythe U.S. Attorney to the Court explaining the FDA's decision stated the following: They [FDA] have refused to provide us with witnesses or documents to support our position ... The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous." The FDA has repeatedly made claims on its website and in recommendations to the Drug Enforcement Administration ("DEA")to schedule kratom'sconstituents as Schedule I substances. The first rejection was issued by the DEA on October 13, 2016 ii with a finding thatthe evidence and data was insufficientto justify scheduling. Then, on August 16, 2018, the Assistant Secretary of Health at the US Department of Health and Human Services issued a scathing withdrawal letter on the FDA's second attemptto schedule kratom's constituents underthe CSA."' When confronted by former FDA Commissioner Scott Gottlieb on the decision. Dr. Giroir called the FDA recommendation "embarrassingly poor evidence and data".iv Finally, the FDAtook its crusade to ban kratom to the international stage where the standards of scheduling are less rigorous than underthe federal CSA. On December 21, 2021, the WHO's Expert Committee on Drug Dependence unanimously concluded there was "insufficient evidence" to justify international scheduling of kratom and refused to even authorize a critical review. 'Case 3:23-cr-00179-TWR Filed 12/06/23 Page ID.1032 Exhibit 6; United States of America, Plaintiff, v. Nine2Five, LLC(1 ) Sebastian Guth ery (2), Defendants https://www.federalregister.gov/documents/201 6/ 1 0/ 1 3/2016-24659/with d rawal-of-n otice-of-inte nt-to-te m porarily-place-m itragy n in e-and-7-hyd roxym itra gyn in e-into https://static1 .squarespace.com/static/54d50ceee4b05797b34869cf/t/60145eab6df59e7e36a7cfc1 /1611947693695/dhilloR8.16.2018-response-letter-from-ash-radm- giroir.pdf lvhttps://twitter.com/DrGiroir/status/1 39S874443726102S33 "Expert Comm. on Drug Dependance, Summary of Assessments, Findings, and Recommendations of the 44th ECDD (2021 ), available at https://cdn.who. inUmedia/docs/default-source/controlled-substances/44ecdd_unsg_annex1 . pdf. DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary Office of the Assistant Secretary for Health Washington, D.C. 20201 AUG 16 2018 The Honorable Uttatn Dhillon Acting Administrator Drug Enforcement Administration U.S. Department of Justice 8701 Morrissette Drive Springfield, VA 22152 Dear Mr. Dhillon: Pursuant to the Controlled Substances Act (CSA), 21 U.S.C. § 81 1, I am rescinding our prior recommendation dated October 17, 2017, that the substances mitragynine and 7- hydroxymitragynine be permanently controlled in Schedule I of the CSA. HHS is instead recommending that mitragynine and 7-hydroxymitragynine not be controlled at this time, either temporarily or permanently, until scientific research can sufficiently support such an action. Mitragynine and 7-OH-mitragynine are two of the constituents of the plant Jwitragyna speciosa (M. speciosa), commonly referred to as Icratom. This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this tithe. Further research, which I am proposing be undertaken, should provide additional data to better inform any subsequent scheduling decision. Procedural History On August 31, 2016, the Drug Enforcement Administration (DEA) issued a Notice of Intent to temporarily schedule the chemicals mitragynine and 7-hydroxymitragynine into Schedule I pursuant to the temporary scheduling provisions of the CSA, 21 U.S.C. § 811(11). See, 81 Fed. Reg. 59,929 (Aug. 31, 2016). In response to the Notice of Intent, the DEA received numerous comments from the public on mitragynine and 7-hydroxymitragynine, including comments offering their opinions regarding the pharmacological effects of these substances. To allow consideration of these comments, as well as others received on or before December 1, 2016, the DEA issued a Withdrawal of Notice of Intent and Solicitation of Comments on October 31, 2016. On October 17, 2017, the then -Acting Assistant Secretary for I lealth of HHS wrote to then - Acting Administrator of the DEA to indicate that HHS was recommending that the substances mitragynine and 7-014-mitragynine be permanently controlled in Schedule I of the Controlled U.S. Public Health Service Substances Act. Recently, I became aware of DEA's intent to schedule mitragynine and 7-OH- mitragynine - into Schedule I. Anal The Controlled Substances Act ("CSA") provides in pertinent part that the Attorney General may by rule add to Schedule I any drug or other substance if the Attorney General makes the findings prescribed by subsection (b) of section 812 of the CSA for Schedule I. See, 21 U.S.C. § 811(a). Such findings are: 1. The drug or other substance has a high potential for abuse. 2. The drug or other substance has no currently accepted medical use in treatment in the United States. 3. There is a lack of accepted safety or use of the drug or other substance under medical supervision. The CSA requires that "[i]n making any finding under subsection (a) of this section or under subsection (b) of section 812 of this title, the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules: (1) Its actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance. (4) Its history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) What, if any, risk there is to the public health. (7) Its psychic or physiological dependence liability. (8) Whether the substance is an immediate precursor of a, substance already controlled under this subchapter." 21 U.S.C. § 811(c). Before scheduling a substance, though, the Attorney General must "request from the Secretary (of HHS) a scientific and medical evaluation, and his recommendation, as to whether such drug or other substance should be so controlled or removed as a controlled substance." Id. at § 8l 1(b). The Secretary's evaluation should be based on factors (2), (3), (6), (7), and (8), noted above, and the scientific and medical considerations involved in factors (1), (4), and (5). Moreover, the "recommendation of the Secretary to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the Secretary recommends that. a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance." Id. The Secretary has delegated to the Assistant Secretary for Health, in consultation with the National Institute on Drug Abuse and the Food and Drug Administration, the responsibility to make a recommendation under the CSA to the Attorney General. On October 17, 2017, my predecessor, the Acting Assistant Secretary for Health, forwarded to you his recommendation that mitragynine and 7-hydroxymitragynine be permanently controlled in Schedule I of the CSA. The recommendation included a scientific and medical evaluation prepared by the FDA of the eight factors determinative of control under the CSA. The FDA evaluation also recommended in favor of the three findings that are required for DEA to place a substance in Schedule I. I have reviewed the Acting Assistant Secretary's earlier recommendation as well as previous and new scientific data. In light of this review, combined with concerns for unintended public health consequences, I now conclude that while mitragynine and 7-hydroxymitragynine have many properties of an opioid, scheduling these chemicals at this time in light of the underdeveloped state of the science would be premature. For example, one recently published peer reviewed animal study indicated that mitragynine does not have abuse potential and actually reduced morphine intake. As such, these new data suggest that mitragynine does not satisfy the first of the three statutory requisites for Schedule I, irrespective of broader considerations of public health. While a single study is rarely diapositive, it strongly suggests that further evaluation is warranted. Although there remains cause for concern for 7-hydroxymitragynine and potentially mitragynine, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time. There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken. It is important that we have additional information to justify scheduling, such as:i • A scientific assessment of how many Americans utilize kratom, and an understanding of the geographic and demographic distribution of these users (Factors 4, 5); • A scientific assessment of the actual scale and degree of dependence and/or addiction of Americans utilizing kratom (Factors I, 5, 7); • A scientific determination based on data whether kratom actually serves as a gateway drug that promotes further use of more dangerous opioids (Factors 1, 4, 5); • A valid prediction of how many kratom users will suffer adverse consequences if kratom is no longer available, including: o Intractable pain, psychological distress, risk for suicide; o Transition to proven deadly opioids such as prescription opioids, heroin, or fentanyl; and o Transition to other potent or harmful drugs (Factor 6); • A scientifically valid assessment of causality in the current few deaths in which kratom was co -utilized with known lethal drugs such as fentanyl (Factors 1, 2, 3, 5 & 6). Furthermore, there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I, such as: ` I am also concerned about the impact of scheduling kratom on our ability to conduct research, especially survey research and our currently inability to routinely test for kratom in those brought into an emergency room as a result of a possible overdose. • Suffering with intractable pain; + Kratom users switching to highly lethal opioids, including potent and deadly prescription opioids, heroin, and/or fentanyl, risking thousands of deaths from overdoses and infectious diseases associated with IV drug use; • Inhibition of patients discussing kratom use with their primary care physicians leading to more harm, and enhancement of stigma thereby decreasing desire for treatment, because of individual users now being guilty of a crime by virtue of their possession or use of kratom • The stifling effect of classification in Schedule I on critical research needed on the complex and potentially useful chemistry of components of kratom. Therefore, I conclude at the current time, available evidence does not support mitragynine and 7- hydroxymitragynine being controlled in Schedule I of the Controlled Substances Act. This assessment supersedes the previous recommendation letter from Acting Assistant Secretary Wright dated October 17, 2017. In the meantime, it is recognized that kratom may potentially have harmful effects, especially in specific circumstances and/or when used with potent prescription or illicit drugs. Finally, it is entirely possible that new data and evidence could support scheduling of chemicals in kratom at some future time. Kratom may have harmful effects, particularly when used with other drugs. As such, I encourage continued enforcement by the FDA against unproven claims by kratom manufacturers. I also support enhanced public awareness that kratom contains molecules that may potentially be dangerous. I also plan to work expeditiously with colleagues throughout the U.S. government to seek transparent public and scientific input, and to collect data on the critical public health considerations outlined above. Should you have any questions regarding this recommendation, please contact my office at (202) 690-7694. Sincerely yours, yv-'-�-Vo Brett P. Giroir, M.D. ADM, U.S. Public Health Service Assistant Secretary for Health Senior Advisor for Opioid Policy Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Faris Khouri To: Kleiman, Lauren Cc: City Clerk"s Office Subject: Kratom Petition Date: March 11, 2024 12:50:21 PM Attachments: Kratom Petition NB.ndf [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the co�fe. To Lauren Kleiman, Hope all is well, attached you find a petition started hoping to reconsider the ban on Kratom in our lovely city in Newport Beach, along with a link to change.org. Please, if you have time, read some of the comments from the public about how Kratom helped saved their lives. htWs://www. change. org//p/urge-newl2ort-beach-city-council-to-reconsider-the-kratom-ban I would love to speak with you on this matter Faris Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Faris Khouri To: DDe t - City Council Cc: City Clerk"s Office Subject: Kratom ban Petition Date: March 11, 2024 12:54:31 PM Attachments: Kratom Petition NB.Ddf [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the hq�e. Hello Council Members, Thank you for your time and hard work you put in every week. Attached is a kratom petition hoping to help the members reconsider the ban. Please, if you have time, read the comments on the changeorg petition and notice the positive impact and live saving plant provided for relief and saved many people. https://www. change. org/p/urge-newport-beach-city-council-to-reconsider-the-kratom-ban We appreciate you Love, Faris Al-Khouri Received After Agenda Printed March 12, 2024 Agenda Item No. 3 Friday March 1 ", 2024 To the Newport Beach City Council, The Petition of Residents and Community Members of Newport Beach, Declares that the petitioners believe that Ordinance No 2024-5. stating An Ordnance of the City Council of the City of Neu port Beach, California, adding Chapter 10. 75 (Prohibition of the We and Distribution of Kratom) to the Title 10 (Offences and Nuisances) of the Neu port Beach Municipal Code, is being enacted arbitrarily and pushed without the proper channels and forum to discuss the impact Kratom has on the community and itt community members. This is an act by the city council to enforce an ordinance without considering the voices of its constituents. There has been no discussion of Kratom in any City Council meeting prior to 02/13/24, and to add it to consent calendar without a genuine conversation with the public seems contradictory to the public good. The petitioners ask the City Council not to pass Ordinance No 2024-5, and to consider its constituents' voices in this matter. NAME ADDRESS EMAIL SIGNATURE H7/ oes, KR1SCAIY1d+� �. / C ox 2,774,�-- flc 41 /31A tA NAME ADDRESS EMAIL SIGNATURE, Cv- _� 3 - C �„�� � C] i:U �jd.r•6ct/t b f `.�. �� G.nas�i 1 Rio jv4,-. (;o 1 &--hu ��7��ftL- v r eu e�eml1b,r+�h, - 3 ��k tr IF�ifi�rsf�c�ly�'r 3, 231) C k - 4;�ETcAcQ. fks it rL IVA0, 1 oL 1 0w ; iiV - �CC-' �f3o�t SA•v 30nt:�►•� c� 2�cE so�1 P �ICw�a�� A ire�J �o ac. �. 2s o ? r (� lE k ra. << ,�L jr' F Q { [ N ¢ w p. 4- R,1 — �.r(Atk �L�a �`� J � 1� � L! �+�1`/1,i�[i C 1 q►rei. rc �n.e, March i .10-14 To the Newport Beach City Council. The Petition of Residents and Community Members of Ne\vport Beach. Declares that the petitioners believe that Ordinance No 2024-5. stating .4n f)rchlance cif the City Council of the C by «f'New/iort Beach, C alilbrnia. acteling C'holver 111. 75 (Prohibition of the Sale and Distribution ql' raimn) to the Title Ill Wfli,nce.s ono Niii-yatices) gf'Ihe New1wrI Beach A4nnicipal Code, is being enacted arbitrarily and pushed without the proper channels and forum to discuss the impact Kratorn has on the comniunity and its community members, This is an act by the city council to enforce an ordinance without considering the voices of its constiniems. There has been no discussion of Kratom in any City Council meeting prior to 02i 1 +124. and to add it to consent calendar svitho►zt a genuine con \ersation with the public seems contradictory to the public good. The petitioners ask the City Council not to pass Ordinance No 2024-5. and to consider its constituents' voices in this matter. DAME . Lrl� r EMAIL I SIGNATURE NAM --- T+ EMAII-. L IGNATURE "0 ems: t 0 _ I% 3 E]�44-= r- y 1 1 irr■ f � �� . Lf IL:LtI ► : �i� rc, 2,CkGw p► `' I`�` '� 'QC7 �I�-�'��o�. ]Pt`� � �-1 c is - ''��'o��"' Friday March 1", 2024 To the Newport Beach City Council, The Petition of Residents and Community Members of Newport Beach, Declares that the petitioners believe that Ordinance No 2024-5, stating An Ordnance of the City Council of the City of Neviport Beach, California, adding Chapter 10. 75 (Prohibition of the Sale and Distribution of Kratom) to the Title 10 (Offences and Nuisances) of the Nei port Beach Municipal Code, is being enacted arbitrarily and pushed without the proper channels and forum to discuss the impact Kratom has on the community and its community members. This is an act by the city council to enforce an ordinance without considering the voices of its constituents. - There has been no discussion of Kratom in any City Council meeting prior to 02/13/24, and to add it to consent calendar without a genuine conversation with the public seems contradictory to the public good. The petitioners ask the City Council not to pass Ordinance No 2024-5, and to consider its constituents' voices in this matter. WO 0101 Oki 0 � 4WX ff/&M NM"IP 'i` �3,- -T r s t �, � �. •T "UM llEA— i� �L:iiii�7 � ► � 4. � . •r fI rimy, u NAME ADDRESS EMAIL SIGNATURE (Ylk, -j— kIlar--dl St Lr:t} 501 K1dl� Q rna,l c� �j,� f __ ��'►"(� I V "���� � 1.3 ��'' ��'1�. [7r �•t � .tom ,�.. �� � r `�►��u yLl� �l 1 t h �iUln�rtit �qq Friday March I', 2024 To the Newport Beach City Council. The Petition of Residents and Conunun1ty M.embcrs of Newport Beach. Declares that the petitioners believe that Ordinance No 2024-5. stating, .-Ir7 Ordnance of-117e Ci(i, Council of1he City ufNewporl Beach, Calijbrnia. udclhr g C •abler- I0..'j (Prohihition (►f the .S'cde wul Dimrih ution of Krutom) to the Tile 10 ((*nces and Nuisances) of Hie Ne►rporl Bench 11funic•ipal Code, is being, enacted arbitrarily and pushed without the proper channels and fortun to discuss the impact Kratom has on the community and its community members. This is an act by the city council to enforce an ordinance without considering the voices of its constituents. There has been no discussion of Kratom in any City Council meeting prior to 021I3124, and to add it to consent calendar without a genuine conversation with the public seems contradictory to the public good. The petitioners ask the City Council not to pass Ordinance No 2024-5, and to consider its constituents' voices in this matter. NAME ADDRESS EMAIL SIGNATURE �c r741 e1A. Ar 1C G �t� d �����G�,, i NAME ADDRESS EMAIL SIGNATURE j n o ago Ca t i tv 5 Pule < < r-4 �7o-1 (J 016 ►.1a:�C� II CA. A Ir y'1 S 6 h "U f i Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:02 AM To: Mulvey, Jennifer Subject: FW: Kratom From: dijonevans <diionevans@gmail.com> Sent: March 07, 2024 7:15 PM To: Dept - City Council<CityCouncil@newportbeachca.gov> Subject: Kratom LICK links or attachments unless you recognize the sender and know the content Hello, My name is Dijon Evans and I am a California resident, and a kratom advocate. Please let me tell you why kratom is so very important to me. I may not currently live in or near Newport Beach but I have certainly spent my share of time there when I was a UCI MC student. This tree has quite literally saved my life, in more ways than I can count!! It has taken me from being completely reliant on my in home care taker -and living my life from either my hospital bed at at home, or the hospital bed in a ICU/ CCU at kaiser Hospital in Sacramento. I am not kidding either! I've gone from spending most of my time in a hospital bed to actually being able to live my life! I have participated in a rally, gone camping ( I could only spend 1 night out, but that night was magical!!! Being outside of the house, looking up at the stars, in a heavily wooded area by a beautiful lake, listening to the wonderful sounds of nature, the breeze, smells, shooting stars- I have been able to go swimming and even though I seriously overdid it o ,o Q, IT WAS A DREAM COME TRUE!! I wasn't supposed to make it to my 35th birthday, or never imagined that I would be able to even see pictures of my 3 grandkids high-school graduations... I not only have seen the pictures of each 3 of their high school graduations, BUT I WENT TO ALL 3 OF THEIR GRADUATIONS!!!!! And I was able to stand up and shout, clap, and the day of the graduations, I had my daughter take us to get them their outfits, their hair done, if they wanted to and I stayed the night with them and somewhat participated in the party for them and their evening afterwards. You may not understand what a miracle this was for us but it was nothing short of exactly that: A MIRACLE!!! There have been so very many things that have happened, and I have absolutely no doubt AT ALL, that each event was just because of kratom I was on my deathbed, particularly the 2 years prior to my starting kratom, especially the year prior to beginning kratom, the 5 months before I had been in either intensive care unit or critical care and when I was home, I had a home health care nurse, as well as my in home health care at home. The 5 months before I began, I was out of the hospital for 9 days. It is still shocking to my Healthcare team, my daughter and grandkids, my " husband " that I am still here I turn 61 in a week even though most of that was without kratom, these last 7+ years weren't without kratom- the time that I have had with kratom has simply been the best! Definitely had my share of challenges, but I know that I wouldn't have been able to get through those challenges without it! I only take 3/4 to 1 tsp twice a day, sometimes only 3/4's a tsp twice a day. Never more. I take at least 2 breaks a year from it. Just absolutely amazing! As embarrassing as it is for me to admit, I was a half hour away from taking my own life on April 29th, 2017. My first package was late. I couldn't deal with the pain, infections, amputations, surgeries or ANYTHING ELSE that I had been going through since I had turned 16, ANYMORE! I have had 3 amputations, 243 surgeries and procedures, 2 pulmonary embolisms, several bouts of sepsis and gangrene, 17 bouts of osteomyelitis, each vertebrae has been either broken, fractured or it has collapsed. I have full body CRPS with organ involvement and it is shutting down each organ one at a time and it will eventually kill me. However, since I have begun kratom, I have changed just about everything else in my life. My eating and everything is far healthier, my weight- finally losing weight. So many things, have changed and it is Directly related to kratom! After almost graduating from medical school ( less than 1 year away. Because of my health and the reasons for my divorce from my first husband- I had taken a medical leave of absence from school and I had every intention of returning!!! I wasn't able to), but every aspect of my life has changed since I have been taking kratom!! I have no doubt that this, and kratom is the reason why I am still here!!! Even though I still have a "terminal " diagnosis, I don't believe that diagnosis is still the case! My labs have all gone from critically low or high, to just about normal. My family no longer gets those " come say your goodbyes, she's not going to make it through the night " phone calls. I feel alive. I am alive. I actually can look/ imagine ahead and see a future. I am not afraid to imagine the future. This tree is nothing short of a miracle for hundreds of thousands of us!!! It is nothing short of a lifeline for millions of people. Please don't ban kratom! Sincerely, Dijon Evans Sent from my MetroPCS 4G LTE Android Device Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:02 AM To: Mulvey, Jennifer Subject: FW: Kratom Ban From: Marcelle Morfin <msmarcellemartin@gmail.com> Sent: March 07, 2024 7:31 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom Ban LICK links or attachments unless you recognize the sender and know the content Rafe. I am an Army veteran who injured my back while on active duty. I've since been diagnosed with spinal cord compression (cervical stenosis with myelopathy aka degenerative cervical myelopathy) along with nerve root compression (radiculopathy) and other painful health conditions too long to list. The spinal cord compression was not caught early enough and so it has caused some permanent damage and the nerve compression causes significant pain. I had surgery in March of 2018 in order to avoid becoming a quadriplegic and will require another surgery within the next five years for another problematic level of my cervical spinal cord. In the spring of 2017, 1 was on the edge looking down. I could not see living with the pain and significant limitations for much longer. The pain, along with depression and anxiety was causing me to start planning my suicide. Just when I was about to give up, over the course of two days, kept seeing people mention Kratom in one of my support groups. They discussed how it had helped to ease their pain. I decided to give it a try because at this point I felt I had nothing to lose. Since then I am able to be a mother, fiance, sister, and friend again. No, I am not made perfect by Kratom, but I have some quality of life back and no longer want to end my life. It has also helped ease my depression and anxiety and I am in better moods as a result. Kratom has changed my life for the better and allowed me enough relief from pain, anxiety, and depression to want to continue living. It has allowed me to be able to play a more active role in my life, rather than watching my life completely pass me by. Kratom has made this possible. Please do not ban kratom. Thank you for taking the time to read my testimony. Sincerely, Marcelle Morfin Disabled Veteran USA Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:04 AM To: Mulvey, Jennifer Subject: FW: Kratom Testimony From: Medea Latham <medealatham2@gmail.com> Sent: March 08, 2024 8:16 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom Testimony LICK links or attachments unless you recognize the sender and know the content im My name is Medea Latham and my Kratom story started in February of 2017. Let me give you a little background. In January 2015 1 was put in the hospital with Pneumonia. I was on continuous oxygen and continued with it after coming home. A few months later, actually Mother's Day of 2015, 1 was getting ready for church. I told my Mom I had the worst headache I had ever had. I went unresponsive and an ambulance was called. They were told that I had a massive brain bleed. They took me to emergency surgery. I was in a coma for about a week. I woke up to being on 4 kinds of blood pressure medicines. I am a disabled RN with 2 young adult sons. At the time, I was bedridden with Multiple Sclerosis and Fibromyalgia. I have COPD and Heart disease and Diabetes. I found out about Kratom in a Fibromyalgia support group from a couple of friends. I did a lot of research on this due to my medical background. After the first time taking it, my Mom , my caregiver asked me how I was feeling. I started crying and told her that I was pain free for the first time in many years. A little over 5 years later, I am no longer bedridden, I am the healthiest I have ever been. My Diabetes is in remission, I am no longer wearing oxygen 24' a day, my pain is still relieved with my Kratom. I still take the same amount I have always taken. I am now my Mother's caregiver. My sons have a Real Mom for the first time in their lives. I am a productive member of society again. Today June 14,2023, 7 years after my brain bleed and surgery, I was finally taken off my blood pressure medicine by my doctor. KRATOM SAVES LIVES. Please consider supporting the Kratom Consumer Protection Act. Thank you for taking the time to read my testimony. Sincerely, Medea Latham 265 S. Bend Rd. Texarkana, TX. 75501 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:06 AM To: Mulvey, Jennifer Subject: FW: Do not ban kratom From: Benjamin Swanson <swanson.benjamin@yahoo.com> Sent: March 08, 2024 10:03 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Do not ban kratom [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. My name Is Ben Swanson, I am a happily Married father of 2. 1 writing you today to request that you not ban kratom. A ban on Kratom will deprive 1000's of great people access to a natural, Safe plant, from the coffee family, whose benefits help Millions of Americans live better every Day. Kratom is not a drug. Kratom is not an opiate. Kratom is not a synthetic substance. Though kratom is relatively new to the United States, Kratom has been used safely for 100's of years in South East Asia as a natural medicine. Kratom in its natural form is a safe herbal tea whose users claim energy, pain relief, depression and anxiety relief and helps users curb addiction to Alcohol and opiates. According To Dr Jack Henningfield, PHD Kratoms' potential for abuse is no more than Nutmeg, Hops, St John's Wort or Coffee. 5 years ago I was about 80 Ibs heavier and hopelessly addicted to Alcohol. I drank almost everyday until was about 35. The older I got the more my back would hurt and the more alcohol I needed. I tried to quit drinking several times but always found my way back. I was arrested a while intoxicated several times and my marriage was beginning to fall apart. In the end I was drinking a fifth of rum every night. In 2015 with the help of Kratom I was able to quit drinking for good and as of today I have not had one sip. The primary reasons for my drinking as I got older was to control my lower back pain so I could sleep at night. Sometimes the pain would immobilize me, require me to limp around with a cane and multiple times prevented me from going out and enjoying life. Alcohol controlled my pain but I could not control the alcohol, and neither could my family. 5 years later I am standing in front of this board a happily married father of 2 begging you to keep Kratom Safe and Accessible to all the good people of San Diego. I have lost too many friends and family members to Alcohol and Opiates, more than I care to count. I only wish they had lived long enough for me to give them a second chance with Kratom. To This Date There has never been a Single Death, Ever in documented history Attributed soley to Kratom. If you are concerned with children using kratom, set an age limit to consume or purchase, If you are concerned for public safety require GMP Compliant packaging in FDA Approved Facilities. Ben Swanson Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:07 AM To: Mulvey, Jennifer Subject: FW: Don't ban Kratom, regulate it From: Misty misteaz Brown <mistyb0512@gmail.com> Sent: March 08, 2024 11:22 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Don't ban Kratom, regulate it LICijwr attachments unless you recognize the sender and know the content im Here's why... In 2008. 1 was diagnosed with degenerative disc disease(L4-L5) and epilepsy. That began a whole slew of different kinds of pain pills, injections, doctors' appointments and pharmacies. I noticed I started becoming addicted to pain pills after I lost my house and my job in 2009 due to my health issues. That and issues going on in my home life slammed me into a deep depression. From then on I couldn't function without a pill. I'd be so out of it for 2 weeks out of the month because my 30 day supply would only last me a couple of weeks. When I wasn't pilled up, I stayed in bed and only did the bare minimum in life until my next doctor's appointment. My pill cocktail was Oxycodone, MS Contin, Soma, Klonopin and fioricet. I was fired from my pain management clinic in April 2019 because I didn't show up for a per contract pill count. I knew I was 11 pills short so I just didn't show up! From May to June my kid's father came out here for my second daughter's graduation. I had already gone through detox and I think he helped occupy my mind. My plan was once we dropped him off at the airport, I was going to start looking for another doctor. Instead, I watched Leaf of Faith on June 25th 2019. 1 learned that Kr@tom is a Southeast Asian herb that many are using for pain relief and to treat addiction. The very next day I went to the local smoke shop and bought some Kr@tom. And here I am today, sober-ish and staying sober-ish because of Kr@tom and w33d! Kr@tom not only brings my pain level from a 10 to a 3, it also stops the opioid cravings and elevates my mood along with the w33d. I am a brand-new version of the old me. I am a thriving and functioning mother and member of society again. Kr@tom and w33d are the tools I need for recovery . In all honesty, I am still amazed that I'm alive today. If you think Kr@tom doesn't work, then by all means ask me how I am a recovered addict today. I and millions of others are living, breathing proof that Kr@tom works! Kr@tom is FREEDOM, Kr@tom is LIFE! Active addi( (2008M 20OF C] Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:18 AM To: Mulvey, Jennifer Subject: FW: My Journey With Kratom From: Wayne Miller <wayneleemiller1977@gmail.com> Sent: March 09, 2024 9:58 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: My Journey With Kratom LICK links or attachments unless you recognize the sender and know the content My name is Wayne Miller and I'm 46 years old and this is my kratom story. Let me preface this with a little family history. My mother's side of the family are almost all alcoholics. Her father ran his car of a bridge around the age of 50, because he was drunk driving, and 2 of her 3 brothers died in their 40s, from alcoholism. My mother, although not as bad they were, is also an alcoholic. I didn't meet my father until i was 24, and when i did, i found out that he also drank at least a 12 pack of beer a day. I spent most of my life addicted to alcohol since age 14. By 16, 1 was drinking every night to the point of being drunk. At 25, 1 started drinking in the morning and all day long. I needed 5 or 6 drinks before work just so I wouldn't shake so bad. Several times, I tried to quit drinking, and within 36 hours, I would go into seizures. Did the detox a few times, but wasn't strong enough to stay away from the alcohol. Went away to a great Christian rehab in 2011. It was a 9 week program and i made it through sober. I followed that up with living at a Christian halfway house for 3 months. Life was new. I was new. It was great. But at some point, you have to live in the unprotected "real world". Within a few months, I started getting those alcohol cravings back. This was 2012. 1 didn't want to go down that road that has brought me and my loved ones so much pain. So I started searching on the internet and found out about a leaf called kratom that some alcoholics had used to quit and abstain from alcohol. I wasn't drinking yet, but was real close. I was very skeptical, but I was desperate not to go back into my own personal hell. It took about a few weeks to get my dosage right, but it worked. I couldn't believe it. I could make it through the day and not be fighting those generational demons that had haunted me my whole life. It was too good to be true. I took it everyday and my quality of life reached a level i had never witnessed or thought possible. Then in 2015/2016, 1 had heard that kratom was getting banned. I had just had my first daughter and didn't want to put that in jeopardy by having illegal substances in my home, so I quit taking kratom. Within 3 weeks, started drinking again. Within 4 months, I had lost everything, including my marriage, license again, job, and relationship with my daughter. February 1, 2017 1 enrolled myself in a year long rehab. Did great there. I can stay sober in a protected atmosphere with no temptaion around me, but unfortunately the world isn't like that. After graduating that program i decided that i would start life over in a whole new area to me just miles from where this rehab was. Within a few weeks, the cravings for alcohol was creeping back. I surely didn't want to go down that road again. I was 40 years old and didn't have much fight or hope in me left should i give in to my addiction. I remember thinking to myself, if only kratom didn't get banned. (I forgot to mention that at the year long rehab, we had no television, internet, etc, so had no way to keep up with what was going on in the real world, let alone the news on kratom). Little did I realize, it was never banned. I ordered some immediately. I sit here writing this 5 years later. I have remarried, I see my child regularly, I have excelled at my job. I own 3 cars (most of my life I barely owned 1 because of DUls, and lack of financial resources because of my addiction). These last 5 years have been my best. I could have saved myself from alot of pain had I found this earlier in life. But I'm lucky. 12 of the guys I was in the year long rehab with, have died from overdose. There is some guilt about me not keeping up with them as good as I should have, because I could have probably saved a few of them by telling them about kratom. I will be forever grateful for this leaf, that gave me a life i never thought was possible. Thankyou Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:19 AM To: Mulvey, Jennifer Subject: FW: I oppose the proposed kratom ban From: Becky Jamin <jaminjewelry727@gmail.com> Sent: March 09, 2024 7:20 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: I oppose the proposed kratom ban LIC tachments unless you recognize the sender and know the content im A I'm a 70 year old great grandmother who has been responsibly consuming pure lab tested kratom for 7 years to help manage my pain and my overall health. I've never had an adverse effect of any kind and I never have to take more than 8 grams a day. Kratom takes my pain from a constant 8-9 down to a very tolerable 3-4. It doesn't take all of my pain away, but it's wonderful to be able to play with my 7 and 4 year old great grandchildren. Without kratom, I'd only be able to watch them play. My medical diagnosis include advanced osteoporosis, osteoarthritis, scoliosis, Chiara Malformation, cervical herniated discs and degenerative joint disease. These conditions will never improve or be cured, but at least, I'll be comfortable as long as kratom is legally available. We kratom consumers are responsible adults and should not have the freedom to choose natural over synthetic taken away from us. Everyone needs to take personal responsibility for anything they choose to ingest. Thank you for taking the time to read this email. Please don't take away this life changing botanical from the thousands of your citizens who take it. Sensible regulation is the proper way to protect your citizens, not a ban. Please consider supporting the Kratom Consumer Protection Act. It's Sensible regulation. Respectfully, Rebecca Jamin Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:20 AM To: Mulvey, Jennifer Subject: FW: Kratom (Prohibition of the sale and distribution of) From: Twinkle VanFleet <twinklev.strongerthanpain @gmail.com> Sent: March 10, 2024 8:09 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom (Prohibition of the sale and distribution of) LIC tachments unless you recognize the sender and know the content im Dear City Council Please support product safety regulations with the Federal Kratom Consumer Protection Act instead of banning and criminalizing Kratom. Kratom offers me a life preserver each day, and it's imperative it remains an option to manage multiple health conditions that include incurable neuro-inflammatory autoimmune disorders with chronic intractable pain. I rely on it as I would a flotation device, life raft or vest that might keep me from drowning. Respectfully, Twinkle VanFleet, 55, California. 916.706.4954 Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:19 AM To: Mulvey, Jennifer Subject: FW: Municipal Ordinance NO. 2024-5 Oppose From: Diane Goldstein <diane@lawenforcementaction.org> Sent: March 09, 2024 2:07 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Cc: Cartwright, Joseph <JCartwright@nbpd.org> Subject: Re: Municipal Ordinance NO. 2024-5 Oppose My apologies to you Mayor Pro Tern Stapleton, I don't know why the entire title did not copy over. Best, Diane Lieutenant Diane M. Goldstein (Ret. J Executive Director (725) 724-1037 c Skype: DianeMGoldstein Twitter: @DianeMGoldstein Law Enforcement Action Partnership On Sat, Mar 9, 2024 at 1:09 PM Diane Goldstein <diane@lawenforcementaction.org> wrote: To the Honorable Mayor Pro, City Council Members and Chief Cartwright, I am writing on behalf of the Law Enforcement Action Partnership, a nonprofit organization composed of current and former police, prosecutors, judges, corrections officials, and other law enforcement officials dedicated to improving public safety through smarter, fairer, and more effective criminal justice and drug policy. As experts with hundreds of years of combined experience in this field, we strongly urge you to not enact NO. 2024-5. The attached letter authored by a constituent and member of our organization lays out the science and evidence that we believe should guide your decision. Feel free to reach out to me if you have any questions. Thank you for your time and consideration in this matter. Sincerely, Diane M. Goldstein Lieutenant Diane M. Goldstein (Ret.) Executive Director (725) 724-1037 c Skype: DianeMGoldstein Twitter: @DianeMGoldstein Law Enforcement Action Partnership JACK BERGMAN 1 ST OISTRIC f, MICHIGAN COMMITTEE ON ARMED SERVICES COMMITTEE ON VETERANS' AFFAIRS congreo of the uniteb *ta:tet Pao of Aeprezentatibez Wofjingt©n, W 20515-2201 March 12, 2024 Congressman Matt Salmon (Ret.) Chairman, American Kratom Association 13575 Heathcote Boulevard, Suite 320 Gainesville, VA 20155 Dear Matt: Received After Agenda Printed March 12, 2024 Agenda Item No. 3 My purpose is writing today is to provide my perspective on the reports from state and local jurisdictions who are proposing bans on kratom, many of which are based on well-intentioned but misplaced concerns by law enforcement and public health officials. Simply put, these proposed bans will create far more harm than any potential benefit kratom critics believe will result from a ban. My specific concern is for the health and welfare of many of our nation's servicemembers and Veterans that I served with and others who returned from their service with injuries and chronic pain. Many of those Veterans have received treatments with dangerous opioids that lead to severe addictions and expose them to the unacceptable risk they will end up as another of the more than 80,000 opioid overdose deaths per year in the United States. One of the tools and resources many Veterans have used to quit their opioid dependence, manage pain, improve mood and focus, and get their lives back on track has been through controlled use of a pure, unmodified kratom product. For many, it has been a miracle solution keeping them from a downward spiral of addiction and destruction. I am certain you have seen during your time in Congress what I see clearly today. The common opponent in our effort to facilitate the recovery of millions of Veterans is the U.S. Food and Drug Administration (FDA). Three times in the last decade, the FDA has attempted to force kratom into Schedule 1 of the Controlled Substances Act, a drastic action that would essentially criminalize the use of the supplement nationwide and harm countless Americans who have benefited from kratom for decades. The FDA, which has a long-standing bias against any supplement that is not a pharmaceutical that can profit Big Pharma and their own budget, has pushed for kratom to be labelled a Controlled Substance by misstating the science, ignoring kratom's long history of safe use, and falsely claiming kratom has the same effects as classic opioids. In their campaign to get kratom reclassified as a dangerous drug, the FDA has relied on three false and thoroughly debunked objections to its widespread use: that kratom is unsafe, that it is highly addictive, and that it has no approved medical use. Even former HHS Assistant Secretary for Health Brett Giroir felt compelled to call out the FDA for relying on "disappointingly poor evidence and data and a failure to consider the overall public health" in coming to such a baseless conclusion. It is rare for a top-ranking HHS official to criticize the FDA for biased, shoddy work, but in this case the unsupported conclusions were so egregious that Giroir felt it WASHINGTON. DC OFFICE YRAVERSF CITY OFFIL.'E GIViNN OFFICE MAH15hOuE BFFFU 566 CANNON HOl15E OFFICE SLOG 1396 DOLH,LAS DR, STE 22B 125 G AvE, SE 9. 119 7876W CO Ro 442. STE B WASH INGTON, DC 20515 TRAVERSE CITY, MJ A9696 GWINpi, M1 49841 MANisTlauE, Mil 4SSE4 12023 226-4735 L231 j 944-7673 1906 h 273 222T 1�1061 256-4191 necessary to publicly criticize them. Likewise, current HHS Secretary Xavier Becerra acknowledged substantial "knowledge gaps" regarding kratom and that "kratom-involved overdose deaths have occurred after use of adulterated kratom products or taking kratom with other substances." While the FDA continues to spread its propaganda about kratom, the Agency itself just concluded a human safety study on kratom that showed that kratom "appears to be well tolerated at all dose levels" (presented by the FDA at the 3rd Annual International Kratom Symposium in Orlando, Florida, February 2024). The study showed that two of the 40 participants experienced nausea after ingesting 12 grams of kratom in 24 capsules in a five minute period. No significant adverse events occurred. That study has now cleared the way for a Human Abuse Potential study to assess what level of dependence or addiction that kratom may cause, if any. That research will take another two years or more to complete. Equally significant is the FDA's refusal to comply with an order by a federal judge in the United States District Court for the Southern District of California to provide witnesses and documents on the FDA's position that kratom is dangerous. The judge called the hearing in a case the FDA itself initiated against a kratom importer. The U.S. Attorney stunningly informed the Court that the FDA "refused to provide us with witnesses or documents ... [and] the reason they gave was that they have not yet made a determination regarding whether kratom is dangerous." Yet, the FDA continues to mislead state and local officials on the safety profile of kratom, including with false statements that remain on the FDA's website today. Any state or locality that proposes to criminalize the sale and consumption of kratom needs to look at the science on kratom, not the gaslighting the FDA continues to engage in. There is no doubt that kratom needs to be regulated to protect consumers from improperly manufactured or deliberately adulterated kratom products, and that is why there are eleven states who have taken that step, with many more currently considering state Kratom Consumer Protection Acts in their states. Senator Mike Lee (R-UT) and I are conservatives, and we have joined with our progressive colleagues, Senator Cory Booker (D-NJ) and Congressman Mark Pocan (D-WI), to lead a bipartisan effort to protect Veterans and the public with a federal Kratom Consumer Protection Act. Please let me know how I can provide additional assistance to you in your efforts as the Chair of the American Kratom Association in the effort to protect all consumers with responsible regulations on kratom. If you have any questions, please notify my staff, Amelia Burns at amelia.burns@mail.house.gov. Thank you for your prompt attention. Kind regards, Jack Bergman Member of Congress Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:41 AM To: Mulvey, Jennifer Subject: FW: Attention From: Matt Williams <gggkov4@vahoo.com> Sent: March 12, 2024 4:00 AM To: Dept - City Council<CityCouncil@newportbeachca.gov> Subject: Attention Please don't ban kratom it helps so many people out. look at the independent research. FDA have been lying for years about kratom Sincerely, Matt Yahoo Mail: Search. Organize. Conauer Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:41 AM To: Mulvey, Jennifer Subject: FW: Concern over Kratom bill From: Jett Facey <jettfacey@gmail.com> Sent: March 12, 2024 12:11 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Concern over Kratom bill LICK links or attachments unless you recognize the sender and know the content Hello, I write to you to keep kratom legalized in Newport beach. Kratom is a valuable tool for thousands - including myself - to manage chronic pain and, most importantly, keep people off harder and more dangerous drugs. Kratom has minimal adverse social effects. It doesn't impair anyone from functioning in society. This is in stark contrast to prescription opiates, which lead to a path of addiction that can only end in death, rehab, or an extremely debilitating withdrawal. These two drugs can do similar things (manage pain). One can ruin your life. The other has no major complications and only relatively minor withdrawals. Banning Kratom will lead to more opiate addiction. More opiate deaths. More suffering. Keep Kratom Legal. Jett Facey Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:40 AM To: Mulvey, Jennifer Subject: FW: Kratom ban From: ckinhb ckinhb <charlakabana@gmail.com> Sent: March 11, 2024 10:49 PM To: Dept - City Council<CityCouncil@newportbeachca.gov> Subject: Kratom ban LICK links or attachments unless you recognize the sender and know the content im Kratom has literally saved my life. I have chronic pain and the strict laws that restrict pain management physicians to give minimal amounts of prescribed pain medication has led many pain sufferers to turn to natural, holistic medicine such as Kratom. Do your research and please allow the sale of Kratom products to continue. Big pharma isn't the only option and should not control legitimate natural remedies that have been tried and tested. Thank you for your time, Charls Kabana (714)322-3873. Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:40 AM To: Mulvey, Jennifer Subject: FW: Comments Against NB Kratom Ban - Bad Idea -----Original Message ----- From: Damon Carr <damon.carr@live.com> Sent: March 11, 2024 10:22 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Comments Against NB Kratom Ban - Bad Idea [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Dear NB City Council, This is the first time I have ever emailed a city council. I was shocked to see the NB city council considering the ban of Kratom tomorrow (3/11), a plant that successfully weaned my brother from severe alcoholism and saved his life. He has been sober now over 10 years and specifically attributes the use of Kratom to help him succeed. My name is Damon Carr my phone number is (949) 278-8962. 1 am a Technology Director for FINRA the financial regulator and spent over a decade working at Pimco. I've helped many friends use Kratom medicinally as a harm reduction approach. I'd ask you what public nuisance Kratom has caused? Kratom saves lives. It helps opiate addicts recover and wean off fentanyl and heroin. What possible good could come from banning this? Feel free to call me if you'd like more information. Thanks, Damon Carr Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:37 AM To: Mulvey, Jennifer Subject: FW: From: Robert Hunter Comer <robertcomer303@gmail.com> Sent: March 11, 2024 9:06 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: LICK links or attachments unless you recognize the sender and know the content im You must be joking, kratom is not even really a drug. It helps get people off of much harder things .... i got off 15mg oxy x4 a day prescribed. Now i use kratom and dont get euphoria I mask the pain Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:37 AM To: Mulvey, Jennifer Subject: FW: Oppose Kratom Ban From: Legato <garret.lecat@gmail.com> Sent: March 11, 2024 7:15 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Oppose Kratom Ban LICK links or attachments unless you recognize the sender and know the content Rafe. To whom it may concern, I strongly oppose the proposed Kratom ban. Please look into the science of Kratom before making a decision. It has helped many, many people. Thankyou Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:36 AM To: Mulvey, Jennifer Subject: FW: Do not ban kratom -----Original Message ----- From: Charles Yahnis <charles.yahnis@gmail.com> Sent: March 11, 2024 6:55 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Do not ban kratom [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Hello, my name is Charles yahnis. I'm extremely opposed to adding kratom to the ban list in Newport Beach, CA. This is not where your energy should be focused. I'm a 34 year old male in excellent health with the exception of 2 herniated discs in my thoracic spine that refuse to heal. I have been through hell for the past 8 years exploring doctor after doctor, mris and X-rays , physical therapy, other tests, invasive procedures, and pain medicines. The only thing that has helped me in the slightest without having any other side effects is Kratom. Kratom has been a force for good in my life and allows me to feel well enough to still care for my family. Please do not ban kratom. Thank you for your time. Sent from my Whone Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:35 AM To: Mulvey, Jennifer Subject: FW: On the prohibition and sale of kratom From: Stephen Dyrnes <stephendyrnes@gmail.com> Sent: March 11, 2024 6:07 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: On the prohibition and sale of kratom LIC tachments unless you recognize the sender and know the content Rafe. To whom it may concern, Please reconsider this prohibition. Kratom has been nothing but helpful for managing pain, and more. It has never caused problems, even after many years of taking. My blood tests have came back normal. My kidneys, liver, and other organs have faced no changes, damage or worse. It has helped my headaches, sore and stiff muscles and joints so I can sleep peacefully. I believe that by banning Kratom, you are inviting pain, suffering and addiction to fester, if not ruin many people's lives. Kratom is not meth, fentanyl, or an opioid. If anything it is closer to coffee than any other substance. Once again, I urge you to reconsider this decision. Thank you for your time and consideration. Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:33 AM To: Mulvey, Jennifer Subject: FW: Oppose kratom ban From: Bryan Murin <bryan.murin@gmail.com> Sent: March 11, 2024 4:53 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Oppose kratom ban LICK links or attachments unless you recognize the sender and know the content im A Hello I am writing to let you know that I Hello I am writing to let you know that I oppose a kratom ban that is being discussed on 5/12. Please look into the actual scientific research being done on kratom. Www.americankratom.org/science There is a lot of misinformation out and half understanding that is referenced by the FDA papers that are listed in your decision to bring this topic up. I support regulating kratom and making sure that adults over 21 have the freedoms that our constitution provides to make informed decisions. I fully support penalties for selling to under 21 and safe responsible use. Kratom has a place and has been proven to be safe and effective instead of the horrible opioids that are plagued by our country. Please listen to actual scientists and who are smarter than myself when it comes to this topic and do not rush to ban it altogether. Please look into the kratom consumer protection act that has been enacted by multiple states that creates a responsible framework to ensure safety of the everyone involved. Thank you for taking the time to listen to a constituent. Regards, Bryan Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:32 AM To: Mulvey, Jennifer Subject: FW: City Council Meeting 3/12/24 Proposed Kratom Ban From: Connie Sanford <hardpanpoppy@gmail.com> Sent: March 11, 2024 3:49 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: City Council Meeting 3/12/24 Proposed Kratom Ban LIC tachments unless you recognize the sender and know the content Dear Council Members, Since I am unable to attend tomorrow's meeting I'd like to share that I oppose the Ordinance No. 2024-5: Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code. I am a senior and have been using kratom daily for serious arthritic pain for many years with no ill effects. Thank You For Your Time, Constance Sanford Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:32 AM To: Mulvey, Jennifer Subject: FW: About the kratom ban -----Original Message ----- From: Roblox is An underrated game <pungeonbyst3am4@gmail.com> Sent: March 11, 2024 3:36 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: About the kratom ban [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Kratom has helped me with my chronic pain which would keep me up at night regularly. It is a much less dangerous alternative than manufactured opioid medications that are usually prescribed for pain. Please do not ban it Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:29 AM To: Mulvey, Jennifer Subject: FW: Kratom Ban From: Alexander Rowe <alexrowe707@gmail.com> Sent: March 11, 2024 1:29 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom Ban LICK links or attachments unless you recognize the sender and know the content im Hello, I am a current LA resident in Playa Del Rey, while I do not live in Newport Beach, it was brought to attention that a Kratom ban is being discussed. I have been a regular kratom user for 5-6 years. I take it a couple times a week. It helps me focus on work and lowers anxiety. I have never had any health issues with it. What Kratom really needs is regulation and research. A ban on kratom will cause users to have to buy from shady vendors and will risk their health. Please please do not give into to the stigma associated with kratom. It needs attention as it helps so many peoples lives. Thanks Alex Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:28 AM To: Mulvey, Jennifer Subject: FW: Kratom Ban -----Original Message ----- From: Brandon Belgard <brandonbelgard@icloud.com> Sent: March 11, 2024 12:39 PM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom Ban [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Banning this extremely beneficial herb Kratom would be a huge injustice to those who've had their lives given to them. I've been taking Kratom daily for 7 years . And for 7 years I'm med free. No more antidepressants, no more anxiety meds .. and I never take any pain medication . I have a spinal degenerative condition called spondylosis. Kratom has single handedly helped me be able to work as a plumber, to be present with my family and have an optimistic outlook on life and my future. Please, do not move forward with banning this herb . You will force people to use medication that gives many negative side effect and or resort to illicit and deadly substances. Banning legal access to this herb would be considered a cruel and unusual punishment for those who use this herb with great success . If you care about your city and its people , keeping this legal and accessible is the only route , regulate to make sure it's pure Kratom without adulteration, that would be a welcomed thing to do . Thank you Brandon Belgard California resident, Plumber and father of 4 Do the right thing , keep this plant legal and accessible Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:25 AM To: Mulvey, Jennifer Subject: FW: City Council Meeting 3/12/24 5pm - Kratom Ban Objection -----Original Message ----- From: J.R. Boyd <jrboyd92@me.com> Sent: March 11, 2024 11:16 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: City Council Meeting 3/12/24 5pm - Kratom Ban Objection [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Good morning, it's come to my attention that a Ban for the plant Kratom is being proposed and discussed tomorrow. I want to express that this plant saved me from a life of hard drug addiction. In my early 20's I struggled immensely with substance abuse and was even sent to outpatient treatment in my Teens. Kratom - a harmless plant is only looked at being banned because it is truly a more effective treatment for addiction reduction than any treatment that any facility could ever imagine offering to its patients. I know myself and countless others have used Kratom as a safe alternative to manage pain. It's even safer than ibuprofen and it does not cause years of irreversible damage to your insides. The opioid crises our country faces is only due to how reliant we are on big pharma, I see a proposed Kratom ban as one step backwards as we are limiting access to tools that will help people that are looking for a better life. JR Boyd 425-394-8520 Sent from my Whone Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim Sent: March 12, 2024 7:24 AM To: Mulvey, Jennifer Subject: FW: Kratom ban -----Original Message ----- From: g seals <gabegirbav@gmail.com> Sent: March 11, 2024 10:13 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Kratom ban [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Do not ban kratom, it's in the same family as coffee and does not get you high like opiates at all, but it works on the receptors, so many people I know choose that over harder and more dangerous substances Received After Agenda Printed March 12, 2024 Agenda Item No. 3 OFOUNDATIONGROLIP March 12, 2024 VIA EMAIL Aaron Harp City Attorney City of Newport Beach 100 Civic Center Drive Newport Beach, California 92660 GREGG D. ZUCKER Office: 310.979.7561 Mobile: 310.403.9227 gregg@foundationlaw.com RE: Ordinance 2024-5 2nd Reading and Adoption Hearing (Consent Calendar) Dear Mr. Harp: We represent Botanic Tonics, a plant -based herbal products company that develops some products containing kratom. Kratom is a tree in the coffee family. Kratom leaves have been used for centuries. The effect of kratom is to enhance energy, physical endurance and mood. Public officials, scientists and consumers recognize the therapeutic benefits of kratom. Comprehensive legislation is required to protect consumers and ensure their access to safe, responsibly manufactured kratom products. Working with constituents and key stakeholders, the City can develop a localized regulatory program while the State and Federal government act on more comprehensive legislation on kratom products. The City, however, proposed an ordinance that generally bans the sale and distribution of kratom, all without any meaningful input from constituents and key stakeholders. This ordinance was proposed through an expedited process that left the Council uninformed. Below is summary of the current policy efforts in the City of Newport Beach related to banning kratom gleaned from our recent review of the Council's video transcripts: February 13, 2024 — Agenda Item XIII — Matters which Councilmembers have asked to be placed on a future agenda (Non -Discussion Item) - Consider adopting an ordinance that bans the sale and distribution of kratom in the City of Newport Beach [Kleiman]. This request was approved unanimously via a straw poll in a matter of seconds. No comments were made by staff or the Councilmembers, and no direction was provided to staff on the matter for public understanding. February 26, 2024 — Agenda Item X . Consent Calendar 3. Ordinance No. 2024-5: Harp, A. March 12, 2024 Adding Chapter 10.75 (Prohibition of the Sale and Distribution of Kratom) to the Newport Beach Municipal Code. Full reading of the ordinance was waived, and this matter was approved with another ordinance on the agenda by a roll call vote of 7-0. Again, this action was taken in a matter of seconds with no discussion or staff presentation such that constituents could be informed. This item was the first time the ordinance language was presented to the Council, and because the item was on the Consent Calendar, there was essentially no public discussion. After both the initial item requesting the staff draft an ordinance and the subsequent hearing on the ordinance introduction, there was less than 30 seconds of discussion before the Council. The discussion was only procedural, depriving the public and stakeholders of meaningful input on the Council's policy -making related to kratom. Now, Ordinance 2024-5 is scheduled for adoption by the Council and is again on the Consent Calendar, repeating a pattern of limited discussion without affording the public any real perspective on the ordinance. We can only presume the Council and staff have had all their substantive discussions in private as the expediency of this development is atypical and lacks detailed findings that depart from State and Federal law. We recommend the following actions be taken by the Council to provide some basic due process related to kratom: 1) Move proposed Ordinance No. 2024-5 from the Consent Calendar and conduct an educational public hearing or study session at a future Council meeting to allow the Council to learn firsthand from stakeholders prior to proceeding further in fast - tracking a prohibition ordinance with little to no public involvement. 2) As the City lacks the public health infrastructure like the County, engage with Orange County Public Health Service to appreciate any public health implications of kratom associated with a ban or regulation. Currently, the staff findings in support of the ordinance fail to include any local information to substantiate a public health concern. 3) Engage with the League of Cities and Members of the Legislature currently proposing legislation to establish a new state-wide regulatory program for kratom —AB 2365. 4) Engage with Members of Congress currently proposing legislation to establish the Federal Kratom Consumer Protection Act — S 3 03 9. 5) Instruct staff to conduct further analysis and make amendments to the ordinance to address the following: a. Include a sunset provision in the event of future passage of State or Federal legislation regulating kratom to avoid preempting State or Federal law. 2 Harp, A. March 12, 2024 b. Analyze local economic activity associated with kratom sales and the potential fiscal impacts of the proposed prohibition, including the costs of enforcement and any loss of tax revenue. Both are significant. c. Distinguish the variety of kratom formulations that have different effects and must be targeted more specifically. d. Develop regulatory standards and adult age requirements (18 and older). e. Develop a registration process for sales of kratom in the City that is consistent with proposed Federal and State law prior to consideration of a prohibition. Please delay adoption of the proposed ordinance and consider the above recommendations. Thank you for your consideration. Sincerely, Greg(/g/D. Zucker Received After Agenda Printed March 12, 2024 Agenda Item No. 3 From: Rieff, Kim To: Mulvey. Jennifer Subject: FW: Protecting access to Kratom Date: March 12, 2024 9:38:41 AM -----Original Message ----- From: aBUCSlife <jjthejoker34@gmail.com> Sent: March 12, 2024 9:37 AM To: Dept - City Council <CityCouncil@newportbeachca.gov> Subject: Protecting access to Kratom [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Dear Esteemed Members of the City Council, I hope this letter finds you in good health and spirits. I am writing to you today with a matter of great importance that has deeply affected my life and the lives of many others in our community: the potential ban on Kratom. For me, Kratom has been nothing short of a lifeline. Struggling with a debilitating addiction to opiates, I felt like I was drowning in despair with no hope of ever resurfacing. That is, until I discovered Kratom. This natural alternative not only helped me manage my pain effectively but also allowed me to reclaim control over my life. Since incorporating Kratom into my daily routine, I have experienced a profound transformation. I have been able to break free from the grips of addiction and rebuild my life from the ground up. Kratom has provided me with the stability and clarity of mind I thought I had lost forever. I understand the concerns surrounding the use of Kratom and the need for regulation. However, I firmly believe that an outright ban is not the solution. Instead, I urge you to consider alternative approaches that prioritize education, responsible use, and regulation. Banning Kratom would not only strip away a vital source of relief for many individuals but also force them back into the cycle of addiction and suffering. It is my sincere hope that you will take into account the stories of those whose lives have been positively impacted by Kratom before making any decisions that could potentially deny them access to this life -changing herb. Thank you for considering my perspective on this matter. I trust that you will make a decision that is both compassionate and informed, taking into account the well-being of all members of our community. With sincere gratitude, Adam Kreisle From: City Clerk's Office Sent: March 13, 2024 10:43 AM To: Mulvey, Jennifer; Rieff, Kim Subject: FW: Kratom Ban —Newport Beach Attachments: GKC Newport Beach _Kleiman.pdf; California Kratom Regulation_vl.pdf; GKC - Backgrounder (Long version)_03112024.pdf From: Matthew Lowe<mlowe@globalkratomcoalition.org> Sent: Monday, March 11, 2024 11:12:29 AM (UTC-08:00) Pacific Time (US & Canada) To: City Clerk's Office <CityClerk@newportbeachca.gov> Subject: Kratom Ban —Newport Beach [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content MLe• Dear Councilmember Kleiman, By means of introduction, I am the Executive Director of the Global Kratom Coalition (GKC). At the GKC we advocate for the responsible manufacture and use of kratom products not only in the US, but on a global level. Please review the attached backgrounder that give more information as to the organization and kratom. I am writing to you in connection with the proposed kratom ban that is scheduled for final hearing on 12th March 2024. We are concerned about the prospect of a ban in Newport, as described in the attached letter. We would also like to bring to your attention that there is a kratom regulation bill that has been filed on a state level AB 2365 - https://trackbill.com/bill/california-assembly-bill- 2365-public-health-kratom/2515626/ . this bill addresses the concerns surrounding kratom whilst still allowing consumers access to this plant that is helping millions of people across the US. Please reference the regulatory breakdown attached. We would very much appreciate a discussion with you before the meeting on the 12th so we can discuss our concerns and see if there are alternate avenues that are worth pursuing. I look forward to hearing from you. Thankyou. Matthew Lowe www.globaLkratomcoatition.org 03/11 /2024 Council Member Lauren Kleiman City of Newport Beach Via email Re: Reconsidering Kratom in light of Forthcoming State and National Regulations Dear Councilmember Lauren Kleiman, I am Executive Director of the Global Kratom Coalition, an alliance of kratom consumers, experts, and industry leaders committed to protecting and expanding access to kratom across the globe. The GKC dedicates resources to advance scientific research and encourage education backed by science in order to protect consumers. The GKC also advocates for regulations designed to ensure that consumers have access to kratom products that are safe. I am writing to share information about regulations currently being considered on the state and national level that may influence your recommendation to ban kratom products in Newport Beach. My hope is the forthcoming regulatory actions will encourage you to delay your proposal. Currently there are several avenues lawmakers are considering that would create a regulatory framework for kratom producers. This legislation would include mandated labeling requirements, such as comprehensive ingredient lists, amount of alkaloids per dose, directions for use, recommended serving sizes and amount of servings per day, appropriate cautionary statements, and implementation of proper manufacturing processes. These regulatory principles create a framework for soon -to -be -adopted regulations that would help ensure a viable industry that can help consumers make informed decisions. In California and other states, lawmakers are currently considering legislation that would regulate kratom and offer the industry guidelines. Kratom Consumer Protection Act (KCPA) is model legislation that generally aims to set age restrictions for purchasing kratom, prohibit the adulteration of kratom products, mandate proper product registration and establish packaging and labeling standards. According to the American Kratom Association (AKA), 11 states have passed some version of the law. Lawmakers in Sacramento are working on legislation that will apply rigorous labeling and other restrictions to kratom products statewide. I can share more details on the plans to introduce this legislation in the current legislative session. Legislators on the federal level are also taking action on kratom. With bipartisan support, U.S. Senators Mike Lee, R-Utah, and Cory Booker, D-New Jersey, and Reps. Mark Pocan, D- Wisconsin, and Jack Bergman, R-Michigan, introduced the Federal Kratom Consumer Protection Act (S 3039 and HR 5905) in October. The proposed legislation aims to establish nationwide regulations for kratom products, mandating the Food and Drug Administration conduct comprehensive assessments of the health and safety of kratom. Additionally, the legislation would prevent the FDA from imposing arbitrary regulations on kratom products that exceed the restrictions placed on food or dietary supplements. The FDA, for its part, has also recently committed to aim to use science and facts to drive policy recommendations which will impact kratom regulations. According to food and beverage market trade Food Navigator, the FDA will "pursue access to accurate information that is easy to understand and transparency into how FDA evaluates food safety." The February 2024 article also quoted Kimberlee Trzeciak, FDA Commissioner for Policy, Legislation and International Affairs: "FDA are doing as much as we can to be more transparent and to provide sufficient assurance that the decisions we are making are science -based." The scientific community is also coalescing around FDA recommendations. As noted at the recent 3rd Kratom Symposium, the nation's leading scientists from well-known universities including Johns Hopkins and University of Florida are strongly encouraging further research on the various forms of kratom to help firmly establish, clarify, or dispel inaccuracies. The FDA's recent leaf kratom Single Ascending Dose (SAD) study and upcoming Human Abuse Potential (HAP) are critical components of the clinical research needed in this space. Initial research from these projects will be released later this year. The GKC believes by conducting robust research, regulators can contribute to a more evidence - based understanding of the various forms of kratom's risks and benefits. Regulations, backed by clinical data, will facilitate informed policymaking and regulatory oversight, which we believe will benefit kratom consumers across the country. As mentioned above, it is my desire that you will consider delaying your recommendation on a ban for products containing kratom. I would welcome the opportunity to discuss these policy matters with you at your earliest convenience. Thank you Matthew Lowe Executive Director Global Kratom Coalition mlowe@globalkratomcoalition.org Kratom Regulatory Landscape: Kratom is legal to sell and consume in 44 states. o Of those states: ■ 11 states have passed the Kratom Consumer Protection Act (KCPA) ■ 12 states are actively considering passing the KCPA. • Kratom is banned to sell and consume in 6 states. o No state has passed a new ban since 2017. o Of the 6 banned states, 4 states are considering repealing their ban based on updated science and understanding of kratom and it's safety profile. California and Kratom: Legislators, scientists, consumers, and industry recognize the therapeutic potential of kratom and the benefits it provides to those who use it. At the same time, there is an understanding that comprehensive legislation is required to protect consumers and ensure their access to safe, responsibly manufactured kratom products. Due to the absence of federal regulation, states are currently responsible for putting forward their regulations. In the context of California, AB 2365 was filed on February 12th, 2024. AB 2365 is the strongest Kratom Consumer Protection bill passed by any state. It considers the realities of the kratom marketplace, the latest scientific findings, the distinction between different kratom formulations, and the need for more informed consumption to protect consumers and responsibly maintain access to safe kratom products. In the face of past concerns about kratom, some cities and councils have rushed to the conclusion of banning it. However, localized bans do not change consumption habits, as consumers may simply travel outside the ban lines to obtain their products, and law enforcement loses control of the problem (if there is, in fact, a problem at all). With robust state regulations in progress addressing issues in the kratom marketplace while still maintaining consumer access, a ban in Newport Beach would be prematurely implementing a solution that may not effectively address the issue. Summary of the Kratom Regulation Bill for California: 1. Clearly define what is and what is not kratom, and not allow adulteration: a. Kratom Leaf: The leaf of the kratom plant, subjected to minimal post -harvest processing. b. Kratom Leaf Extract: Material obtained by extracting kratom with specified solvents, containing mitragynine as the predominant alkaloid. c. Kratom Product: Food or dietary supplement containing kratom leaf or extract, excluding synthesized kratom constituents or any adulterants, and limiting 7- Hydroxymitragynine levels found in kratom products to under 1 % of total alkaloids. 2. Set packaging and labeling standards: a. Retail package labels must comply with federal allergen labeling requirements. b. Labels must include age restrictions (18+), health warnings, manufacturer information, and directions for use including the recommended serving size, and the amount of servings that can be safely consumed in a day. c. Liquid kratom products limited to 3 servings in containers, unless equipped with a calibrated measuring device. Powdered products must have calibrated measuring devices. 3. Prohibition of sale to person under 18: a. The sale of kratom products to persons under the age of 18 is prohibited. 4. Registration: a. Processors require a valid annual registration from the Department. b. Registration includes a certificate of analysis from an accredited third -party laboratory. c. Processor must pay an annual fee covering administrative costs. d. Failure to comply with testing or fee requirements will result in revocation of registration. 5. Enforcement: a. Violations will lead to denial, suspension, or revocation of registration. b. Proceedings follow the guidelines outlined in the Government Code. GLOBAL KRATOM C O A L I T I O N Global Kratom Coalition BACKGR0UNDER 2024 C About Us ............................................................................... 3 Our Vision ............................................................................... 4 Our Values ............................................................................... 5 AboutKratom..................................................................... 6 Not All Kratom is Equal......................................................... 6 KratomTaxonomy................................................................... 7 Kratom is Not an Opioid....................................................... 8 Addiction Profile ...................................................................... 9 RelativeSafety........................................................................... 10 Poison Control Center Statistics ................................... 10 Calls per Substance..................................................... 11 Calls per 100K................................................................. 12 Calls Resulting in Deaths ........................................... 13 CDC, FAERS, and CAERS Data Analyses .............. 14 Summary Comparison Death Rates ..................... is Support from Top Scientists ................................................ 16 Moving Forward................................................................. 17 Regulation & Legislation 17 ....................................................... About l Global Kratom Coalition (GKC) is an alliance of kratom consumers, experts, and industry leaders committed to protecting and expanding access to kratom across the globe. We dedicate resources to advancing scientific research, driving consumer education, and developing robust regulations that are backed by science and protect consumers. GKC focuses on kratom product safety, scientific advancement, and consumer education. Whilst GKC's foundation is based on the traditional use of kratom in Southeast Asia, GKC acknowledges the rise and market demand for kratom extracts in the United States. GKC advocates for the distinction between kratom leaf, extracts, concentrates and isolates, as'not all kratom is equal', while also advocating for regulations designed to ensure that consumers have access to kratom products that are safe. 40 www.globalkratomcoalition.org 3 info@globalkratomcoalition.org *11 Our Vision We envision a world where kratom products are recognized as a safe and natural option for those seeking to enhance their well-being, supported by a thriving scientific community dedicated to unlocking its potential. We envision a future where consumers have access to high -quality kratom products, fair and reasonable regulations exist for kratom products, and the kratom science flourishes, providing greater understanding and knowledge. 1� r .- M it J L Our Values Access We believe that individuals should have the choice as to how they look after their health and wellness. This choice should be informed by the latest unbiased information available. We work to protect and expand access to kratom products across the world while dedicating resources to advancing scientific exploration so consumers can make informed decisions. Education We are dedicated to providing accurate, evidence - based information about kratom products, and empowering consumers to make informed decisions. Advocacy GKC serves as a united voice for kratom product consumers worldwide, advocating for fair and sensible regulations that prioritize consumer safety, freedom of information, and good manufacturing practices. Consumer choice and safety are at the core of our advocacy efforts. Community We foster a global community of kratom enthusiasts, experts, vendors, and advocates who share our passion for kratom. Together, the community will promote the benefits of kratom and fight for informed and responsible use. The community will drive regulation that protects kratom products and users. Responsibility We promote the responsible use of kratom products --"M and encourage vendors to adhere to strict quality and safety standards, ensuring consumers have access to kratom products that are safe, well - manufactured, and labeled appropriately. DAbout Kratom Kratom is a tropical evergreen tree (Mitragyna speciosa) native to Southeast Asia, where for centuries, it has been used to increase endurance and enhance mood.. Kratom is traditionally consumed in various forms, such as dried powders, fresh leaves, or brewed teas/decoctions. It is often categorized as an herbal supplement in the western world, though its classification varies by region and country. The most well -studied psychoactive compounds found in kratom are called alkaloids. Mitragynine, an indole alkaloid, is the most abundant while of the other alkaloids found in quantifiable amounts include speciociliatine, speciogynine, and paynantheine, among others. These alkaloids interact with receptors in the brain, influencing mood and energy levels. However, due to the complexity of the alkaloids found in kratom, its mechanism of action is not yet fully understood. Not All Kratom is Equal The reason for much of the confusion, conflation, and misinformation that dominates news about kratom is that there is very little understanding that not all kratom is the same. Critically, all products derived from kratom - including leaf material, extracts, concentrates, and isolates - are called "kratom" without consideration of the inherent differences in potency of these product types. Additionally, adulteration of kratom products is prevalent. Some manufacturers have been known to boost their products' 7-hydroxymitragynine content, for example, which can only be accomplished through chemical manipulation.' While others have added synthetic or illicit substances to kratom products resulting in deadly consequences.2 Furthermore, alkaloids from different product types will have different levels of exposure, which may lead to unexpected adverse effects. Unfortunately, reporting of adverse events does not make a distinction between kratom product types which has the effect of lumping all forms together, making it difficult to understand the safety of individual kratom products and provide guidelines for regulation of different product types. GKC is dedicated to educating individuals on the differences in kratom product types and providing definitions to be used by educators, scientists, industry, and regulators so that not all products are called "kratom" moving forward. 1 Lydecker, A.G.; Sharma, A.; McCurdy, C.R.; Avery, B.A.; Babu, K.M.; Boyer, E.W. Suspected Adulteration of Commercial kratom Products with 7-Hydroxymitragynine. J Med Toxicol 2016,12, 341-349. 2 Kronstrand, R.; Roman, M.; Thelander, G.; Eriksson, A. Unintentional fatal intoxications with mitragynine and O- desmethyltramadol from the herbal blend Krypton. J Anal Toxicol 2011, 35, 242-247. Taxonomy Acknowledging that the term "kratom" cannot encompass all products derived from Mitragyna speciosa, it is important to develop a clear way of talking about kratom in its various forms. It is also important to distinguish between what is and what is not kratom or kratom derived. GKC endorses distinguishing between Mitragyna speciosa (the tree, i.e. "kratom"), leaf kratom (dried and ground kratom leaf), kratom extracts (that match the alkaloid profile of the leaf) and kratom isolates (isolated specific kratom alkaloids). Kratom derived isolates of individual alkaloids or synthetically derived alkaloids are a cause of concern for the industry. There is not enough known about the use of specific isolated alkaloids or synthetically derived alkaloids to determine their safety. These products cannot be considered under the taxonomy of kratom as they differ too greatly from the plant. This is referenced in the taxonomy diagram below: Kratom Taxonomy 4� Mitragyna Speciosa Fresh leaves used traditionally in Southeast Asia 4PLeaf Kratom Dried ground leaves of Mitragyna Speciosa Kratom Kratom Extracts Isolates Leaf Kratom exposed to solvents to remove fiber and concentrate all alkaloids (extracts) or individual alkaloids (isolate) At, . Kratom is Not an Opioid Leaf kratom is not an opioid, though its compounds, like those of many other substances, interact with the opioid receptor system. When it comes to the opioid receptor system, there are numerous compounds that interact with and activate this system that are commonly consumed, such as many dairy products and compounds ingested from barley and gluten.3 Additionally, sugar triggers the production and release of endogenous opioid compounds.4 Compounds found in kratom products interact with opioid receptors, as well as multiple other receptor system types. The distinction between the function of alkaloids and those of illicit, prescribed opioids lies in their downstream effects. Drugs like heroin and codeine interact strongly with the p-opioid receptor subtype, which triggers G-protein coupled receptors downstream, causing the deleterious side effect of respiratory depression that can lead to overdose. Research into mitragynine, meanwhile, has shown that respiratory depression isn't triggered.s 3 Tyagi, A.; Daliri, E. B.; Kwami Ofosu, F.; Yeon, S. J.; Oh, D. H., Food -Derived Opioid Peptides in Human Health: A Review. Int J Mol Sci 2020,21 (22). 4 Avena, N. M.; Rada, P.; Hoebel, B. G., Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neuroscience and biobehavioral reviews 2008,32 (1), 20-39. 5 Henningfield, J. E.; Rodricks, J. V.; Magnuson, A. M.; Huestis, M. A., Respiratory effects of oral mitragynine and oxycodone in a rodent model. Psychopharmacology 2022, 239 (12), 3793-3804. Addiction Profile While there is a potential for dependence with long-term and frequent use, the abuse potential of kratom is considered lower than that of traditional opioids, and symptoms of withdrawal are mild. Responsible use is key to minimizing risks. In general terms, addiction is defined as a medical disorder. The National Institute on Drug Abuse defines addiction as a "chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences.116 Having a physiological dependence on a substance does not necessarily mean that a person has an addiction to that substance. There are few documented reports of kratom addiction globally. One review of clinical case reports found only 55 cases in which a clinician evaluated, in some manner, symptoms related to leaf kratom physical dependence or addiction -like symptoms.' In regions where kratom is indigenous, Malaysia and Thailand in particular, there have been self -reports of mild to moderate symptoms of craving, tolerance, and withdrawal among people who consume kratom regularly. However, the functioning of these regular consumers does not show clear impairments that would be typical of a substance use disorder or addiction; rather, there is more indication of physical dependence. 8 9 10 11 12 Similar to reports from Southeast Asia, where many use kratom as part of everyday life, the social, psychological, occupational, and daily functioning of people who use kratom in the U.S. does not seem to cause impairment, even in cases where physical dependence signs are present.13 1415 National Institute on Drug Abuse (NIDA). Drug misuse and addiction. (2020, July13). Retrieved December 21, 2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drug-misuse-addiction. Smith, K. E., Feldman, J. D., Schriefer, D., Weiss, S. T., Grundmann, O., Dunn, K. E.,... & Epstein, D. H. (2023a). Diagnostic ambiguities and underuse of clinical assessment tools: A systematic review of case reports on kratom addiction and physical dependence. Current Addiction Reports,l0(2), 282-292. Saingam, D., Singh, D., Geater, A. F., Assanangkornchai, S., Jitpiboon, W., & Latkin, C. (2023). The Health Impact of Long - Term kratom (Mitragyna Speciosa) Use in Southern Thailand. Substance Use & Misuse,1-14. Singh, D., Narayanan, S., & Vicknasingam, B. (2016). Traditional and non-traditional uses of Mitragynine (kratom): A survey of the literature. Brain Research Bulletin,126, 41-46. Singh, D., Muller, C. P., & Vicknasingam, B. K. (2014). kratom (Mitragyna speciosa) dependence, withdrawal symptoms and craving in regular users. Drug and alcohol dependence,139,132-137. Singh, D., Muller, C. P., Vicknasingam, B. K., & Mansor, S. M. (2015). Social functioning of kratom (Mitragyna speciosa) users in Malaysia. Journal of Psychoactive Drugs, 47(2),125-131. Singh, D., Narayanan, S., Muller, C. P., Swogger, M. T., Rahim, A. A., Leong Bin Abdullah, M. F. I., & Vicknasingam, B. K. (2018). Severity of kratom (Mitragyna speciosa Korth.) psychological withdrawal symptoms. Journal of psychoactive drugs, 50(5), 445-450. Garcia-Romeu, A., Cox, D. J., Smith, K. E., Dunn, K. E., & Griffiths, R. R. (2020). kratom (Mitragyna speciosa): user demographics, use patterns, and implications for the opioid epidemic. Drug and alcohol dependence, 208,107849. Smith, K. E., Dunn, K. E., Epstein, D. H., Feldman, J. D., Garcia-Romeu, A., Grundmann, O., ... & Weiss, S. T. (2022a). Need for clarity and context in case reports on kratom use, assessment, and intervention. Substance Abuse, 43(1),1221-1224. Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. T., Grundmann, O., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology,14,1174. Interviews undertaken by researchers at NIDA found that some regular U.S. kratom consumers did not report withdrawal symptoms, whereas others had mild withdrawal, but all described how kratom was a routine part of their daily and weekly routines.16 Individuals who use kratom regularly do not show impairments in daily functioning or hazardous use. This makes sense when we remember that some of the reasons why people use kratom are often to be productive and highly functioning in their everyday lives.11 18 A limitation of the current research is that most individuals are using leaf kratom products, so similar studies and interviews must be conducted for other types of kratom products like extracts, concentrates, and isolates. So, while there is presently some evidence to suggest that regular or prolonged use of leaf kratom may result in tolerance or withdrawal and physical dependence, there is no evidence to support assertions that leaf kratom use is resulting in concerning symptoms of compulsive use despite adverse consequences. What seems most likely to occur from regular, prolonged use of leaf kratom, particularly by those who consume large amounts, is dependence, not addiction. Relative Safety On a micro level, kratom, when used responsibly, is considered safe for many individuals. Still, it's crucial to be aware of proper serving sizes, potential side effects, and individual differences in reactions to kratom products. On a macro level, it is important to put any risk posed by kratom in context —specifically by comparing it to the risk profile of other widely used and available substances. Below, the safety and abuse potential of kratom is discussed relative to other substances. Poison Control Center Statistics The following graphs present statistics on calls to U.S. Poison Control Centers between 2017 and 2021, organized by substance (see "Calls per Substance"). When normalized by 100,000 users (see "Calls per 100K Users"), ibuprofen, a substance considered relatively safe, has the most calls to poison control centers, but these calls do not result in death. By far, the most deaths concern opioids, followed by alcohol and antidepressants. There were only 15 calls that resulted in death after kratom ingestion, whereas opioid calls that resulted in death were almost 1,500 in the same 5-year period (see "Calls Resulting in Deaths"). 16 Smith, K. E., Feldman, J. D., Dunn, K. E., McCurdy, C. R., Weiss, S. T., Grundmann, O., ... & Epstein, D. H. (2023b). Examining the paradoxical effects of kratom: a narrative inquiry. Frontiers in Pharmacology,14,1174. 17 Grundmann, O., Veltri, C. A., Morcos, D., Knightes III, D., Smith, K. E., Singh, D.,... & Swogger, M. T. (2022). Exploring the self - reported motivations of kratom (Mitragyna speciosa Korth.) use: a cross -sectional investigation. The American Journal of Drug and Alcohol Abuse, 48(4), 433-444. 18 Smith, K. E., Dunn, K. E., Rogers, J. M., Grundmann, O., McCurdy, C. R., Garcia-Romeu, A., ... & Epstein, D. H. (2022d). kratom use as more than a "self -treatment". The American Journal of Drug and Alcohol Abuse, 48(6), 684-694. Poison Center Calls Per Substance 2017 - 2021 This graph presents the total call numbers for each of the included substances. Calls regarding kratom barely register. Of course, that is partly because kratom is used far less frequently than these other substances. The following graph controls for this context. 200000 150000 100000 MOIGIGI61 0 P Q�° 2017 2018 Q.� Source: American Association of Poison Control Centers 2019 2020 2021 Jp 4�1 Poison Center Calls Per 100K Users 2017 - 2021 This graph presents call numbers as proportions of 100,000 users of each substance. Again, calls for kratom incidents barely register, comparing most closelywith calls regarding energy drinks. 600 S00 400 300 200 100 0 e'0 o� NG P 2017 2018 2019 2020 2021 Source: American Association of Poison Control Centers & CDC & SAMHSA user data Poison Center Calls Resulting in Deaths 2017 - 2021 And this graph presents calls that resulted in deaths, again putting the risk associated with kratom consumption in context. S00 400 472 455 300 284 200 125 5108 100 0 ■ ■ 2017 2018 35 44 33 tik 610 � 7 11 5 6 2 4 1 1 1 4 4 1 1 1 4 20 10 11 A� -Mt — 2019 2020 2021 1 0 1 1 0 1 01 1 0 1 2 3 5 4 e Go40 \Go P ,10 P Source: American Association of Poison Control Centers `o0 CDC, FAERS, and CAE RS Data Analyses It has been widely reported that kratom deaths are increasing at an "alarming rate." When reviewing the FDA Adverse Event Reporting System (FAERS), the CFSAN Adverse Event Reporting System (CAERS), and the Centers for Disease Control and Prevention databases for kratom-related deaths, it is evident that the majority of deaths associated with kratom are linked to polysubstance use or other mitigating circumstances. This context is graphed below, between 2019 and 2021, showing a declining rate of kratom-only deaths. Kratom Death Analyses 2019 to 2022 2019 2020 2021 2022 f Poly Drug Use f Other Circumstances / Needs more info No additional factors Source: Nutrasource independent review of FAERS, database 2019 to 2022 Summary - Comparison Death Rates 2021 (Normalized Per 100k Users) In the context of overall substance use in the U.S., where sugar is included, the data illustrates that kratom presents a much lower risk than alcohol, tobacco, sugar, and opioids. 40.00 /• •• • •• Tobacco Alcohol Sugar Opioids Kratom Marijuana Kava Source: Nutrasource independent review of FAERS, database 2019 to 2022 Support from Top Scientists Leading scientists endorse the distinction between different kratom product types. Dr. Christopher R. McCurdy_ and Dr. Oliver Grundmann, professors at the University of Florida's College of Pharmacy_, have greatly advanced research into kratom, its compounds, and their potential therapeutic benefits, most recently with their paper "Not all kratom is equal: The important distinction between native leaf and extract products," which published in October 2023. Some important excerpts from this publication include: • "While unaltered kratom leaf material contains the active ingredient mitragynine in amounts of about 2 percent, the recent emergence of kratom extracts has resulted in products containing 40 percent or more mitragynine by weight." • "Products containing kratom extracts may not be available in various formulations, such as tablets, capsules, liquid shots or gummies, that appeal to consumers based on better palatability (circumventing the unpleasant taste of native kratom leaf or powder material). Better taste can lead to the ingestion of higher amounts of mitragynine, raising questions of consumer safety and abuse potential. It is well -documented that kratom misuse can lead to adverse and toxic effects, leading to a dependence described as "kratom use disorder." • "As researchers studying the therapeutic potential of kratom, while also desiring to reduce possible associated harms, we strongly recommend that kratom in its native form (unadulterated fresh or dried leaf materials) remain available to consumers." • "In addition, there must be thorough and proper oversight and regulation, including clear labeling that describes the amount of mitragynine per kratom dose, recommended maximum daily doses, potential for drug interactions, and implementation of proper Good Manufacturing Practices (similar to what is done for other dietary supplements). • "Given the limited scientific data on the risks and toxicity of concentrated kratom products, consumers should approach them with extreme caution and hope for more government oversight." • https://thehill.com/opinion/healthcare/4379508-the-rest-of-the-us-needs-to-follow-floridas- lead-a nd-sta rt-reg u lati ng-kratom-extracts/ GKC is dedicated to maintaining the stance that not all kratom products are created equal and urging further safety research into different product types that are available on the US market. . Moving Forward Regulation Kratom- neither a conventional food nor an approved drug -doesn't fit neatly into any federal regulatory category, which has allowed for holes in oversight. As of December 1, 2023: • Kratom is legal to sell and consume in 44 states. Of those: 0 11 states have passed regulations protecting consumers (i.e., kratom Consumer Protection Acts, or KCPAs) 0 12 states are actively considering regulations protecting consumers • Kratom is illegal to sell and consume in 6 states. Of those: 0 2 states are reviewing their bans Legislation The Global Kratom Coalition (GKC) recognizes that existing state -level legislation does not fully address the complexities of the kratom market nor fully addresses concerns around consumer safety and experiences. The need for more comprehensive legislation is evident to protect consumers and ensure they have access to safe, responsibly manufactured kratom products. Our efforts are geared towards pushing for more rigorous standards and eliminating bad actors from the market. Due to the absence of Federal regulation, it is currently incumbent on states to put forward robust regulations that ensure that manufacturers produce safe products to ensure that consumers maintain safe access to the benefits of kratom. States have moved to pass various bills to ensure that consumers have access to responsibly manufactured and safe kratom products. In California, kratom is currently legal to be sold and consumed, except for in the city of San Diego and the city of Oceanside. The city of San Diego passed ordinance 20657 to ban kratom on June 15th, 2016, citing concerns over public health and safety. However, California legislators have the opportunity in 2024 to move forward with introducing legislation that would regulate leaf kratom products. Legislation from other states offers a vision of what legislation might look like in California. Recently, California Assembly Member Matthew Haney, in consultation with the Global Kratom Coalition, proposed The California Kratom Consumer Protection Act (CKCPA) in the 2024 legislative session. This is a significant step forward as, for the first time, legislation is being put forward that truly takes steps to make the kratom marketplace safer for consumers by: I. The GKC is working on developing science that will determine what a safe serving of kratom is. Once determined, GKC will advocate for instituting limits on the amount of total alkaloids allowed per serving of a kratom product and will make recommendations regarding what is a safe total daily intake of a kratom product. In the meanwhile, GKC will legislate that kratom products have clear serving size directions, and calibrated measuring devices where appropriate. 2. Ensuring that kratom products are adequately labeled to ensure that consumers are informed as to how they should consume the product safely. 3. Establishing enforcement mechanisms and funding for regulations to ensure that regulations are not just put into legislation but are actively exercised to ensure that vendors are not running foul of the stipulations put forward. 4. Require manufacturers to follow cGMP rules that, if not followed, will result in manufacturers having their permit to sell kratom revoked in the state. The GKC believes that stringent regulations are an absolute requirement to ensure that consumers maintain access to safe kratom products that can be of significant benefit to their everyday lives. The GKC will actively pursue stringent regulation in all states across the US. From: City Clerk"s Office To: Mulvey, Jennifer; Rieff, Kim Subject: FW: Keep Kratom Legal Date: March 12, 2024 7:57:32 PM From: Bonni Cutler <bonnicutler@yahoo.com> Sent: Tuesday, March 12, 2024 7:56:42 PM (UTC-08:00) Pacific Time (US & Canada) To: City Clerk's Office Cc: Dept - City Council Subject: Keep Kratom Legal [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Certainly, here's a polished version: Greetings, I am a 58-year-old woman holding a master's degree in higher education. Presently, I serve as the supervisor of an employment program dedicated to aiding the homeless in reintegrating into the workforce. Since 2014,1 have incorporated Kratom into my routine upon discovering its remarkable alleviation of rheumatoid arthritis symptoms. Kratom has profoundly enhanced my quality of life. Prior to its use, I struggled through each workweek, often too fatigued for leisure activities. However, thanks to Kratom, I not only attained my master's degree but also lead an active and fulfilling life once again. I implore against the prohibition of Kratom, as it serves as a source of profound relief for countless individuals. Sincerely, Bonni Cutler Sent from my Whone From: City Clerk"s Office To: Mulvey, Jennifer; Rieff, Kim Subject: FW: Kratom Ban Date: March 14, 2024 3:59:26 PM From: Elliot Scharf <escharf08@icloud.com> Sent: Thursday, March 14, 2024 3:59:05 PM (UTC-08:00) Pacific Time (US & Canada) To: City Clerk's Office Subject: Kratom Ban [EXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the content is safe. Hello, I am emailing you because I am disappointed about the kratom ban in Newport Beach. It is a magical herb that has helped me with alcohol dependence. Please reconsider this. Thank you! Sent from my iPhone From: City Clerk"s Office To: Mulvey. Jennifer; Rieff. Kim Subject: FW: Repeal the Unjustified Kratom Ban in Newport Beach Date: March 15, 2024 9:42:36 AM From: Maher Kakish <upinsmokesmokeshop@gmail.com> Sent: Friday, March 15, 2024 9:42:14 AM (UTC-08:00) Pacific Time (US & Canada) To: Kleiman, Lauren <Ikleiman@newportbeachca.gov> Cc: City Clerk's Office <CityClerk@newportbeachca.gov> Subject: Repeal the Unjustified Kratom Ban in Newport Beach rEXTERNAL EMAIL] DO NOT CLICK links or attachments unless you recognize the sender and know the Eontent is safe. Dear Councilmember Kleiman, I am writing to express my deep frustration and disappointment regarding your decision to implement an ordinance banning Kratom in Newport Beach. As a small business owner in our community whose livelihood relies on the sale of Kratom, this ban has inflicted significant financial harm, amounting to hundreds of thousands of dollars in damages annually. Your actions to ban Kratom without any credible justification are not only unjust but also irresponsible and ignorant. It is evident that you have been misled by misinformation regarding Kratom, including baseless claims about its availability to minors. I urge you to reconsider your stance and examine the facts surrounding Kratom's use and benefits. Contrary to the misinformation you have propagated, Kratom has been shown to provide numerous health benefits and has a low potential for abuse and addiction. Numerous studies have demonstrated its potential in alleviating chronic pain, anxiety, and depression, without the adverse side effects associated with traditional opioids. Moreover, a prohibition on Kratom will not only harm legitimate businesses like mine but will also negatively impact the community. Many individuals rely on Kratom as a safer alternative to pharmaceutical drugs, and depriving them of this option will only exacerbate the opioid crisis we are already facing. I implore you to listen to the voices of your constituents and base your decisions on facts rather than unfounded prejudices. I urge you to repeal the ordinance banning Kratom and work towards implementing evidence -based policies that truly serve the best interests of Newport Beach. Furthermore, as a concerned citizen, I cannot help but wonder about the motives behind your unwarranted attack on Kratom. Are you truly acting in the best interests of our community, or are there undisclosed influences guiding your decision -making process? The lack of transparency raises questions about potential financial incentives from unidentified parties. Sincerely, Mousa Kakish Up In Smoke Newport Beach Sources: Henningfield, J. E., Fant, R. V., & Wang, D. W. (2018). The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research. Psychopharmacology, 235(2), 573-589. Swogger, M. T., Hart, E., Erowid, F., Erowid, E., Trabold, N., Yee, K., ... & Walsh, Z. (2015). Experiences of kratom users: a qualitative analysis. Journal of Psychoactive Drugs, 47(5), 360-367. Coe, M. A., Pillitteri, J. L., Sembower, M. A., Gerlach, K. K., & Henningfield, J. E. (2019). Kratom as a substitute for opioids: Results from an online survey. Drug and Alcohol Dependence, 202, 24-32.