On December 1, the American Botanical Council filed comments in response to the U.S. Drug Enforcement Administration (DEA) Solicitation of Comments regarding the scheduling of two compounds in the kratom (Mitragyna speciosa) plant into Schedule I of the Controlled Substances Act (CSA).
ABC set forth to the DEA in its comments that emerging science supports viable potential medical uses of the alkaloids mitragynine and 7-hydroxymitragynine in kratom, and that scheduling these substances into Schedule I of the CSA may impede current and future medical research efforts. ABC also acknowledged the actions that the U.S. Food and Drug Administration (FDA)—the principal federal agency with enforcement authority over food, dietary supplement, and drug products—has initiated to remove kratom products labeled as dietary supplements from the marketplace (1). ABC emphasized that these FDA enforcement efforts should continue to ensure that only kratom products that comply with FDA regulations are available in the market.
On August 31, 2016, the DEA filed a Notice of Intent to temporarily schedule the two substances, mitragynine and 7-hydroxymitragynine, into Schedule I of the CSA (2). These substances are found in kratom, a tree native to Southeast Asia, and have been the subject of increased media headlines over the past two years.
Due to the almost 15,000 comments received from the public, Congressional members and the scientific community, the DEA withdrew its original notice to temporarily schedule kratom alkaloids, and instead, opened a comment period until December 1, 2016 (3). The DEA intended to use this time to consider the extensive comments already received, to solicit additional information from the public, and to request FDA’s expedited scientific and medical evaluation and scheduling recommendation for these substances.
ABC has been reviewing the scientific literature related to kratom and recently published an extensive peer-reviewed article on this plant and the various issues related to its use (4). ABC’s review explores the complex science of kratom, and examines the data that the DEA cited to support the temporary scheduling of mitragynine and 7-hydroxymitragynine. The article also served as the foundation to ABC’s comments to the DEA.
ABC’s comments to the DEA stated that there is a body of evidence on kratom that demonstrates the medical and therapeutic potential of the plant and its constituents, in particular the potential benefits to alleviate the symptoms of opioid withdrawal and the management of pain. ABC noted that further research is needed to fully discover kratom’s medicinal value and to understand more fully the potential risks and safety considerations, such as addiction potential. However, ABC referenced medical research suggesting that kratom’s addictive potential is significantly less than that of conventional opiates.
ABC also emphasized that by putting these substances on Schedule I, the medical research community will be subject to additional hurdles, such as obtaining a registration from the DEA (and likely a state registration), along with other security, inventory and record-keeping requirements (5) that may impede and/or curtail current and future research efforts.
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References
- Food, Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
- The DEA has the authority to temporarily schedule a substance if it finds that such action is necessary to avoid an imminent hazard to the public safety. (21 USC 811(h)(1)).
- The possible outcomes post December 1, 2016, include DEA proceeding with a temporary or permanent scheduling (or both) of these substances. If the DEA determines a permanent scheduling is warranted, the DEA will publish a notice of proposed rulemaking in the Federal Register which will allow the public another opportunity to provide comments and request a hearing.
- Yearsley C. Kratom: Medicine or Menace? HerbalGram. November 2016;112:46-59.
- 21 CFR §1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances.
