Kratom leaf-based products, from a South East Asian tree in the coffee family, are marketed as dietary supplements and often consumed in home brewed tea-like beverages or commercial products. Several million Americans consume kratom annually to increase alertness, enhance wellbeing and occupational performance. Kratom is also used as a natural remedy for several types of pain and, by an apparently rapidly growing number of people who had histories of opioid use, for pain and/or addiction – as a path away from opioids. On behalf of the American Kratom Association, PinneyAssociates developed a review of the scientific evidence regarding kratom’s effects according to the 8 factors of the Controlled Substances Act (CSA) to assist FDA and DEA in determining the most appropriate regulatory approach within FDA authority to permit appropriate use of kratom, as well as to minimize unintended effects, encourage research, and contribute to the enhancement of public health.
Our assessment, principally authored by Jack Henningfield and Reginald Fant, concluded that there is neither evidence that kratom is contributing to the opioid crisis or that kratom itself poses “imminent threat to public health” (the usual justification for emergency scheduling by the DEA). Furthermore, banning kratom could reasonably be predicted to produce public health problems that do not presently exist as the lawful kratom market would be replaced by a dangerous black market. Surveys suggest that if kratom were removed from the market many former opioid users benefiting from kratom (whether they had been using opioids to manage pain or because they had developed abuse or addiction problems) would return to use of opioids, licit and illicit. As stated by Dr. Henningfield, “This does not mean kratom products should not be regulated; to the contrary[,] we need reasonable and balanced regulation to reassure consumers that the ingredients of the products they purchase [are]… true to the product labels, that packaging and labeling are overseen by FDA, and that the lawful marketing of this life-line category of products is not taken away from those who have come to rely on it as an alternative to opioids and other substances.”
“Our work on kratom is an example of how we help regulators and industry make scientifically informed decisions about the risks and benefits of pharmaceuticals and dietary supplements,” said Dr. Henningfield. “Appropriate regulation and scheduling that considers multiple lines of evidence could help keep the risks low and the safety profile strong.”
Read the 8-factor assessment here.