FDA Gathers Public Comment on Looming Global Kratom Ban

Should kratom be banned on a global scale? Published in the Federal Register on July 23, the U.S. Food and Drug Administration (FDA) is now seeking public comment to inform the U.S. position on how the plant should be scheduled under international statute.

Public comment will help inform the FDA’s position on kratom regulation ahead of an October meeting of the World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD), where international officials will discuss whether to recommend the substance be globally scheduled.

Kratom and its two active compounds—mitragynine and 7-hydroxymitragynine—are in pre-review status, according to WHO. The pre-review process determines if there is sufficient evidence to bring the substance before the ECDD for a formal review; “findings at this stage should not determine whether the control status of a substance should be changed,” according to the WHO notification.

“Kratom Madness” is sweeping the world as the plant’s properties become widely known. But supporters believe that the plant is a beneficial natural alternative to opioids, with compounds that bind to opioid receptors, but with fewer risks than powerful opioids. The number of synthetic opioid deaths moved far beyond the total number of drug overdose death tolls from heroin, methamphetamine and other street drugs, providing an urgent reason for an opioid replacement. There are real risks associated with kratom, but nothing compared to opioids like fentanyl.

There are only a few days left to voice your opinion before the deadline approaches on August 9.

“The Food and Drug Administration (FDA) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of seven drug substances,” the FDA wrote. “These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).”

As of the time of writing, over 5,000 comments flooded the comment section.

The implications go way beyond the United States. Marijuana Moment reports that Mac Haddow, senior fellow of public policy at the American Kratom Association, believes an FDA ban could be significant: “If that happens, there are 37 countries that are part of that international treaty that will effectively ban kratom around the world,” Haddow said in a video. “The FDA cannot get kratom scheduled here in the United States using the criteria that’s established by the Controlled Substances Act, so they’re circumventing that and going to the WHO.”

Public comment can be submitted here either electronic or written comments by August 9.

However, the AKA came out and said that while the FDA is required to provide a forum for public comment, they are not required to submit the comments to the U.N. Expert Committee. They only have to “consider” them. As an alternative, the AKA created, and are recommending, that comments be left at this submission portal instead. To ensure they make their way directly to the WHO.

Statewide Efforts to Regulate Kratom

The Oregon Kratom Consumer Protection Act would allow people 21 and older to purchase kratom. Both the Oregon House and Senate approved the bill in June, but the state’s governor did not quite agree.

Governor Kate Brown said on August 1 that she plans to veto it, in large part because she feels the FDA is better suited to regulate the products.

“Given there is currently no FDA-approved use for this product and there continues to be concern about the impacts of its use, I would entertain further legislation to limit youth access without the state agency regulatory function included in this bill,” Governor Brown said.

To prevent overdoses from contaminated kratom, Utah lawmakers passed legislation that has kept kratom legal with regulations—however, lawmakers have restricted who can sell it, how it’s manufactured, how it’s labeled, and who can buy it.

Several other states have enacted legislation that would either ban or regulate kratom. Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin have banned kratom, according to Sprout Health. Stay tuned.