September 16th, 2021
Official Release: 8-Factor Analysis findings demonstrate kratom poses no imminent threat, should not be banned by FDA or WHO
Access Updated 8-Factor Analysis Here
WASHINGTON, D.C. – September 16, 2021 – The American Kratom Association (AKA) highlighted significant findings in a new analysis that confirms kratom's safety profile and clearly demonstrates that the World Health Organization (WHO) and U.S. Food and Drug Administration’s (FDA) efforts to ban or restrict the herbal supplement are without merit.
“The recent 8-FA affirms what previous studies have concluded: that kratom is safe and that efforts by FDA and WHO to ban it are unfounded,” said Mac Haddow, Senior Fellow of Public Policy at the American Kratom Association. “We are encouraged to have these results finalized prior to the World Health Organization’s October meeting and hopeful that it and the tens of thousands of public comments gathered so far in support of kratom will put the brakes on efforts to schedule this supplement under the Controlled Substances Act. What the kratom community has long urged for is reasonable oversight by FDA to ensure its safe manufacture and usage in the U.S. so that its benefits can be realized to the fullest extent possible.”
“Our study concludes that there is no evidence kratom poses an imminent threat to public health and that kratom is not like opioids in its safety and addiction risks,” said Dr. Jack Henningfield, who oversaw the 8-Factor Analysis. “Furthermore, our findings confirm the conclusion made by former Assistant Secretary of Health Brett Giroir that millions of people who use kratom as an opioid alternative or to treat opioid addiction would be at risk of relapse and overdose should possession of kratom become criminalized. In order to ensure safe use of kratom and to limit its abuse and misuse, our report concludes that such issues are best addressed by allowing the legal sale of kratom with appropriate FDA oversight as a dietary supplement and ingredient.”
In summary, the report concludes:
- There is no evidence that kratom poses an imminent threat to public health, which is a requirement for emergency scheduling and a key consideration in permanently scheduling a substance.
- Thousands of people using kratom to combat opioid addiction would be at risk of relapse and overdose should sale of kratom be banned.
- Banning kratom would foreseeably lead to an illicit kratom market with increased problems related to contaminated and adulterated kratom products.
- Current problems with contaminated or inappropriately marketed kratom can be best solved by reasonable FDA oversight, whereas a scheduling ban would leave consumers hostage to illicit and unregulated kratom.
Dr. Henningfield’s findings reaffirm an earlier study from 2018. Since that study, there have been more than 100 new published scientific studies, reviews, and commentaries by leading kratom experts, and an accelerating research pipeline funded in part by the US National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA). These studies provide an increasingly strong evidence base for regulation and policy and provide a fuller characterization of how kratom works and how it provides the benefits that many people report as their reason for use, but without narcotic-like addiction and overdose risks.
The studies include the types of state-of-the-art animal abuse and physical dependence / withdrawal studies that FDA requires for new medicines and which DEA relies on for drug scheduling decisions. New clinical studies in humans provide initial assessments of kratom’s physiological health and safety related effects on liver, kidney, and cardiovascular function, as well as brain function, using magnetic resonance imaging techniques.
The AKA has long fought efforts from the FDA and now WHO to schedule kratom as a controlled substance. It is currently collecting comments ahead of an October 11-15 meeting of the WHO Executive Committee on Drug Dependency where a recommendation will be made on whether to implement international restrictions or a ban on kratom.