On December 1, 2016, the nonprofit American Botanical Council (ABC) filed comments in response to the US Drug Enforcement Administration’s (DEA’s) request for comments on the proposed listing of two compounds found in the Southeast Asian herb kratom (Mitragyna speciosa, Rubiaceae) in Schedule I of the Controlled Substances Act (CSA).
Schedule 1 substances are “those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.”
In its comments, ABC stated that emerging scientific evidence supports potential medical uses of the kratom alkaloids mitragynine and 7-hydroxymitragynine, and that placing these substances in Schedule I of the CSA may impede current and future medical research efforts. ABC also acknowledged the actions that the US Food and Drug Administration (FDA) — the principal federal agency with enforcement authority over food, dietary supplement, and drug products — has initiated to remove certain kratom-containing products 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.
Due to the almost 15,000 comments received from the public, Congressional members, and the scientific community, the DEA withdrew its original August 31, 2016, notice of intent to temporarily schedule the alkaloids, and instead, opened a comment period through December 1, 2016. (Since the comment period has ended, the DEA may choose to proceed with a temporary and/or permanent scheduling of these substances. If the DEA determines a permanent scheduling is warranted, it will publish a notice of proposed rulemaking in the Federal Register, which will allow for an additional public comment period.) The DEA intended to use this time to consider the extensive comments already received, to solicit additional information from the public, and to request the FDA’s expedited scientific and medical evaluation and scheduling recommendation for these substances.
ABC has reviewed the scientific literature related to kratom and, in HerbalGram issue 112, published an extensive peer-reviewed article on this plant and the various issues related to its use.2 The article also served as the foundation of ABC’s comments to the DEA.
ABC stated that there is a growing body of evidence that indicates that kratom and its constituents may have the potential to be safe and effective pain-relievers and recovery aids for opioid addiction or dependence. ABC also noted that further research is needed to fully discover kratom’s medicinal value and its potential risks and safety considerations, such as addiction potential. However, ABC referenced medical research that suggests that kratom’s addictive potential is significantly less than that of common opioids.
ABC also emphasized that by putting these substances in Schedule I, the medical research community will be subject to additional hurdles — such as obtaining a license from the DEA (and likely a state registration), along with other security, inventory, and recordkeeping requirements3 — that may impede and/or curtail current and future research efforts.
“ABC realizes that there are compelling scientific data to support kratom’s potential therapeutic uses; there is also confusion about its safety profile,” said Mark Blumenthal, founder and executive director of ABC. “Our comments to the DEA are intended to help ensure that appropriate scientific and medical research on this interesting plant and its biologically active constituents can continue with minimal regulatory hurdles.”
To add further support to ABC’s position that the DEA should not list these substances in Schedule I, ABC raised concerns regarding the data cited by the DEA to support the temporary scheduling. Specifically, ABC believes the safety profile of the plant is not wholly known, and that a more thorough investigation of the relationship between kratom and adverse event reports provided by the poison control call centers needs to be performed. For example, some of the data cited by the DEA include cases of kratom being used with various analgesic and/or sedative pharmaceutical drugs. Also, ABC noted that, in many cases, there was a lack of analytical testing of commercial kratom products to identify the possible presence of other substances that may have contributed to the adverse reactions.
ABC believes that the potential benefits of kratom warrant further scientific and medical investigation, and that putting kratom compounds in Schedule I would create excessive obstacles to research on a plant that could benefit a large number of people.
- Food, Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
- Yearsley C. Kratom: medicine or menace? HerbalGram. 2016;112:46-59.
- 21 CFR §1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances.