Emerging science supports potential medical uses of the alkaloids mitragynine and 7-hydroxymitragynine in kratom, substances that the US Drug Enforcement Administration (DEA) is attempting to regulate. The non-profit American Botanical Council (ABC) recently submitted comments to the DEA, urging the group to halt its restrictive plan, stating that scheduling substances into the Schedule I of the Controlled Substances Act (CSA) may impede current and future medical research efforts, according to a statement published by ABC on December 1.
The group also submitted comments to the US Food and Drug Administration (FDA) on December 12, requesting the agency revise its industry guidance on kratom use. The FDA previously took action to remove kratom products labeled as “dietary supplements” from the marketplace. In its comments to the DEA, 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 into Schedule I. The substances are found in kratom, a tree native to Southeast Asia, and have been a topic of discussion in the media in recent years. The DEA received roughly 15,000 comments, including push-back from Congress and the scientific community, so the group withdrew its original notice and opened a comment period, which closed December 1. In this time, the DEA would consider comments, solicit additional information from the public, and request the FDA’s expedited scientific and medical evaluation and scheduling recommendation for these substances.
ABC did its own investigation, reviewing the scientific literature related to kratom. The group recently published an extensive peer-reviewed article on this plant and the various issues related to its use, which served as the foundation for its comments to the DEA. ABC 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, along with other security, inventory, and record-keeping requirements, which may impede on current and future research efforts.
The organization also raised concerns regarding the data cited by the DEA to support the temporary scheduling. ABC says the safety profile of the plant is not wholly known, and that a more thorough investigation of the causality between kratom and adverse event reports provided by the poison control call center needs to be performed. Some of the data on adverse events cited by the DEA include use of kratom with various analgesic or sedative pharmaceutical drugs. ABC also 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 reaction.
ABC says that the potential benefits of kratom warrant further scientific and medical investigation, and that putting kratom compounds on Schedule I would create excessive obstacles to research on a plant that may be beneficial to a large number of people.