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11/01/2022 Meeting Minutes
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North Olmsted Legislation
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11/1/2022
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2022
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and is believed to be the primary naturally occurring kratom constituent the provides the effects"' that <br />consumers report is the basis for their consuming kratom products. <br />The study also complements two other studies that employed well-established models for comparing <br />substances to morphine with respect to physical dependence and withdrawal. Those studies found very <br />low levels of withdrawal"" ""' produced by mitragynine exposure as compared to morphine. This is <br />consistent with surveys and field studies" x 'suggesting that even in heavy long term users of kratom <br />who might experience withdrawal from kratom when they stop using it, the effects are generally far less <br />intense and more readily self -manageable than those produced by abstinence from morphine and other <br />classic addicting opioids. In fact, these studies and other evidence also indicate that many people report <br />using kratom to self -manage opioid addiction, craving, and withdrawal though this is not recognized as <br />an approved safe and effective use by health authorities.."" ""' <br />Dr. Jack Henningfield, an internationally recognized expert in the assessment and regulation of <br />substances with a potential for abuse and addiction who was not involved in the study, stated, "This <br />new study provides important additional scientific evidence that kratom does not warrant regulation as <br />morphine -like opioid (i.e., "narcotic"). Nor should kratom be described as opioid -like with respect to its <br />abuse potential or addictiveness or safety profile based on this study and other research"" x°'"' Dr. <br />Henningfield"' has researched and contributed to the regulatory approaches for many substances and <br />new drugs through his studies with the National Institute on Drug Abuse, Johns Hopkins University, and <br />other research institutions, and provides consulting support through PinneyAssociates on drug <br />regulation as well as kratom science, including advising to the American Kratom Association. <br />Dr. Henningfield further commented: "Abuse potential assessment and substance regulation is strongest <br />when based on a broad range of types of laboratory studies and real world evidence to understand the <br />pharmacological effects, safety and public health risks and benefits, as recommended in FDA's 2017 <br />guidance: Assessment of the Abuse Potential of Drugs.`""' This was the approach by my colleagues and I <br />in our analyses"" of kratom's abuse potential and our regulatory recommendations. It is exciting to see <br />kratom research efforts increasing and using a broad range of techniques such as the animal self - <br />administration, ICSS, and withdrawal models, and studies of potential therapeutic effects, as well as <br />surveys of real world use and effects in the US and other countries such as by Malaysia's Center for Drug <br />Research."" <br />Relevance of COVID-19 and the Opioid Epidemic <br />Dr. Henningfield added: "The COVID-19 pandemic on top of the opioid overdose epidemic adds to the <br />urgency of regulatory approaches to preserve access to kratom by consumers but with product <br />standards to address safety concerns. Kratom was the lifeline away from opioids for many people before <br />the COVID pandemic because for many people formal treatment programs and FDA approved treatment <br />approaches were not accessible, effective or acceptable. The COVID pandemic has been associated with <br />increased opioid overdose deaths and impaired access to formal addiction treatment programs.""' <br />Utah State Senator Curt Bramble, the primary sponsor of the first state legislation to provide for <br />responsible regulation to prevent adulterated kratom products, agreed: "Now is not the time to <br />reduce access to kratom. Now is the time for other states and ideally the Federal government to follow <br />2 <br />The American Kratom Association is tax-exempt 501-C4 consumer advocacy organization dedicated to protecting <br />and preserving consumer access to safe and unadulterated kratom products. <br />
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