DEA Drops Proposed Kratom Scheduling Action, Seeks FDA Guidance
The Agency has opened a public comment period and seeks input from the FDA.
The Drug Enforcement Agency (DEA) has withdrawn its notice of intent to schedule the active constituents of the nutritional supplement kratom. The agency cited numerous challenges to the legality of the proposed emergency scheduling action.
Kratom is a botanical related to the coffee plant. It contains an alkaloid that’s a weak agonist of the mu opioid receptor. Higher doses can cause mild euphoria, dizziness, and nausea. Kratom coadministered with other drugs has been associated with 14 deaths.
Kratom is usually consumed as a tea or powder mixed with water. In some cases, it’s prepackaged with flavoring or put into capsules. The supplement’s popularity has markedly increased in the past several years.
Currently, most kratom users take it to relieve pain or anxiety. Some also use it to relieve withdrawal symptoms from traditional opiates. The opioid-like effects of kratom are limited because its alkaloids are only partial agonists of the mu receptor and adopt a binding pose distinctly different from that of conventional opioids. There’s evidence that kratom itself may have addictive properties, but it’s thought to be less habit-forming than traditional opiates.
Researchers argue that the active constituents of kratom may be lead to compounds for a new generation of less addictive pain relief drugs. Classifying these compounds as Schedule I substances would stop nearly all research in this area.
Fifty-one congressmen publicly opposed the kratom ban and expressed a concern for a lack of transparency in the scheduling process. Another group of 9 US Senators wrote to the DEA and cited that the “use of this emergency authority for a natural substance is unprecedented.”
The DEA has requested that the FDA submit an expedited “scientific and medical evaluation and scheduling recommendation” for mitragynine and 7-hydroxymitragynine, the active alkaloids of kratom. The DEA is also opening a period for public comment until December 1, 2016. When the public comment period ends, the DEA will consider the input and will have the option to leave kratom unregulated or pursue regulatory changes.
Withdrawal of notice of intent to temporarily palce mitragynine and 7-hydroxymitragynine into schedule I. Federal register website. federalregister.gov/d/2016-24659.