Henningfield JE, Swogger MT, Walsh Z, Kruegel AC, Grundmann O, Garcia-Romeu A, Raffa RB, Griffiths RR, Brown P
June 12, 2018
Dear Leader McConnell, Leader Schumer, Speaker Ryan, and Leader Pelosi:
We write today to address the U.S. Food and Drug Administration’s (FDA) recommendation to the Drug Enforcement Administration (DEA) to schedule the kratom plant and its two biologically active alkaloids, mitragynine and 7-hydroxymitragynine, under Schedule I of the Controlled Substances Act (CSA). Based on the substantial science and safety signal data, we conclude that kratom does not meet the statutorily mandated criteria for Schedule I substances based on their potential for abuse, safety, dependence liability, and medical use (if any).
Therefore, we strongly recommend that the DEA return the scheduling recommendation to the FDA for additional review and research and encourage the FDA’s Office of Dietary Supplements to appropriately regulate kratom products. This matter is urgent because there is a foreseeable negative public health consequence if legal kratom is banned: thousands of former opioid users will be at risk of returning to high-risk opioid use and may add to our nation’s opioid overdose epidemic.