American Kratom Association Policy Brief: Is Kratom Safe?

The American Kratom Association recently released a policy brief titled “Is Kratom Safe?” in which they argue against the FDA’s attempts to schedule kratom as a Schedule I substance. According to the brief, the FDA’s claims that kratom is responsible for deaths are not supported by credible data and do not justify scheduling the substance.

The brief highlights that the responsibility for protecting Americans from dangerous substances is delegated by Congress to the Drug Enforcement Administration (DEA), not the FDA. The Controlled Substances Act (CSA) requires the DEA to apply strict criteria in classifying substances to appropriate scheduling levels, and the FDA’s powers are limited and require coordination with the National Institutes on Drug Abuse (NIDA) in making recommendations on substances they deem appropriate for scheduling.

Despite the FDA’s two specific recommendations to schedule kratom as a Schedule I substance, the DEA has refused to take any action to schedule kratom in the more than 3 years since the first recommendation was made. Independent reviews of the FDA data claiming deaths associated with kratom have shown no credibility in meeting the burden for scheduling. In fact, research funded by NIDA has directly contradicted the FDA’s claims that kratom has a high addiction liability, which is one of the key factors required for scheduling. The NIDA research also shows that kratom offers real potential to replace more dangerous treatment options like opioids for acute and chronic pain management.

The policy brief also claims that the FDA knowingly uses false “kratom-associated” death claims to advocate for kratom bans at the federal, state, and local government levels. The US Congress has recognized the potential value of kratom in fighting opioid use disorder.

Since the FDA’s 2017 recommendation to schedule kratom, there have been numerous credible peer-reviewed research articles published that further undermine the claims made by the FDA against kratom, including NIDA-funded research projects that directly refute the FDA’s claims that kratom has a dangerous addiction liability.

The DEA’s withdrawal of the initial scheduling recommendation by the FDA for kratom’s two primary alkaloids, mitragynine and 7-hydroxymitragynine, was based on “numerous comments from members of the public challenging the scheduling action” that included bipartisan letters signed by 51 members of the United States House of Representatives and 13 members of the United States Senate objecting to the DEA’s scheduling notice.

The policy brief concludes that the FDA does not have the authority to schedule or ban kratom, and only the DEA holds that power under the CSA. The DEA has refused to take any action to schedule kratom despite two attempts by the FDA in the 4 years that have elapsed since the first recommendation was made. The brief argues that the FDA’s attempts to demonize kratom through a coordinated disinformation campaign are an attempt to bypass the statutory requirements for scheduling at the federal level and create a de-facto ban on kratom at state and local levels.

The implications of this policy brief are significant, as they suggest that the FDA’s claims against kratom are unfounded and that kratom could have potential benefits in fighting opioid use disorder. If the DEA continues to refuse to schedule kratom, it could open up the possibility for further research into the substance’s potential benefits and drawbacks, as well as potential legal challenges against the FDA’s attempts to demonize it.

Overall, the policy brief argues that kratom is safe and that attempts to schedule or ban it are based on false information and misguided attempts to demonize the substance. Whether or not the DEA will eventually schedule kratom remains to be seen, but the policy brief suggests that there are strong arguments against doing so based on the available evidence.