‘Embarrassing mistake’: FDA withdraws notice of proposed study on kratom, psychedelics

The U.S. Food and Drug Administration has withdrawn a notice regarding a proposal to study Americans’ use of kratom and psychedelics.

The move came just days after the agency announced Aug. 2 in the Federal Register that it intended to investigate the risk and safety considerations, as well as motivations for buying and consuming, kratom and psychedelics — whether alone or with other substances. In Monday’s edition of the Federal Register, Lauren K. Roth, associate commissioner for policy, said FDA “no longer intends to proceed with the proposed study as described because circumstances occurred necessitating changes to the scope of the study.”

Roth’s statement displayed a date of Aug. 6 but was not published in the Federal Register until Aug. 12.

FDA would not elaborate for this article on the nature of the circumstances that warranted changes to the study’s scope.

“We don’t have any additional details to provide on this beyond what’s published in the Federal Register,” a spokesperson for FDA’s Center for Drug Evaluation and Research said.

The American Kratom Association, however, pounced on the development.

“This is the latest embarrassing mistake driven by a few anti-kratom staff at the FDA,” Mac Haddow, senior fellow on public policy with the AKA, said in an Aug. 12 press release.

Related:FDA issues another kratom warning following death

Haddow blamed FDA staff for trying to undermine kratom’s harm-reduction properties, and he pointed to the National Institute on Drug Abuse as delivering positive examples of how to explore the potential around kratom and psychedelics.

“[I]t is time for [FDA] Commissioner [Robert] Califf to exercise direct oversight and order the agency to reassess its biased attacks on kratom and psychedelics,” Haddow added.

How FDA’s kratom and psychedelics study would have been conducted

On Aug. 2, FDA filed a notice in the Federal Register about its proposed research into kratom and psychedelics and requested public comment.

“This study seeks to capture information on how consumers make decisions about how, where and why they buy these substances; what, if any risk/safety considerations and tradeoffs they take into account in the decision-making process; and the behavioral considerations in assessing the quality of the product and perceived harm to self,” FDA wrote.

The study would have farmed out data collection to The Brightfield Group, whose database comprises about 5,000 contacts. The Brightfield Group bills itself as a research firm targeting the “global cannabis, CBD and emerging wellness industries.”

Related:FDA doubles down on kratom in dietary supplement products

The Brightfield Group did not immediately respond to requests for an interview.

The final FDA report containing The Brightfield Group’s findings would have included feedback from 800 online survey respondents (half self-identifying as having taken both kratom and psychedelics, the other half having consumed neither substance), as well as 36 in-depth participants who each would have given an hour-long interview.

FDA has estimated that 1.7 million people in the U.S. use kratom, though AKA stated in 2023 that over 15 million Americans use the botanical. A new report from research organization RAND said about 8 million Americans took psilocybin, the mushroom-based form of psychedelics, in 2023.

It’s not clear how or why FDA decided to group kratom and psychedelics into the same study. Kratom is an herbal substance derived from leaves found on trees in Southeast Asia. Psychedelics, on the other hand, come from plants and mushrooms. To that end, the Psychedelic Medicine Association does not list kratom on its “featured compounds” page.

While their origins differ, anecdotes and some research papers indicate that both kratom and psychedelics have helped opioid users wean off dangerous, highly addictive drugs such as heroin and fentanyl. Many alcoholics make the same testimonial. People who use kratom and/or psychedelics also testify to the substances’ abilities to improve their quality of life in areas including pain, fatigue, depression and anxiety. Plus, one 2023 paper in the National Library of Medicine notes, “psychedelics do not have the addictive potential of opioids.” Proponents of kratom have made similar observations.

A different approach

The AKA’s Haddow said the U.S. government needs to take a different approach to regulating kratom in particular. He called on FDA’s commissioner to convene meetings with scientists, policy experts and consumer advocates to talk about the “next best steps” for protecting access to safely manufactured, properly labeled and age-restricted kratom.

“Until then, the FDA remains trapped in the web of their own making that unfairly demonizes products like kratom and psychedelics that, when properly used, are helping people who struggle with addictions and mental health issues and that are saving lives,” Haddow said.

The majority of the 155 submitted public comments by Aug. 12, and viewed by SupplySide Supplement Journal, concurred with Haddow’s view. Many supporters shared stories about how kratom, especially, has made their lives better and asked FDA to go easy on legal oversight.

Commenter Cheryl Scher is just one of those advocates.

“Kratom helped the pain I felt but even more so, helped my fatigue, which has been taking away my quality of life,” she wrote to FDA. “There are no side effects when I take it except the occasional constipation, which is easily corrected by increasing my fluid intake. That’s it, nothing else. There is no high from it, no respiratory depression and no impairment in any way, shape or form. Kratom is a blessing for so many people. The only outcome of restrictions or bans [is] the deliberate destruction of people’s lives by forcing them on strong addictive pharmaceuticals that cause way more problems than it solves [sic].”

Still, not everyone is on board with a light regulatory touch for kratom.

“Kratom is addictive and dangerous,” Wendy Chamberlain told FDA in her public comment. “My son died 8/30/2020 from accidental mitragynine toxicity. He had no other substances of any kind in his system. He didn’t consume alcohol and lived a healthy lifestyle. A 38 yr old young man just doesn’t simply fall asleep and never wake up. My son used a popular brand … which was GMP-certified according to the American Kratom Association. It wasn’t adulterated. I have been advocating to get kratom scheduled.”