FDA Backs Off Joint Study On Kratom And Psychedelics Amidst Public Criticism

The Food and Drug Administration (FDA) has unexpectedly withdrawn its request for White House permission to conduct a study on the risks associated with kratom and psychedelics. As Marijuana Moment reported, this move comes in response to growing public criticism, particularly from advocates who have accused the agency of displaying a consistent bias against harm reduction strategies.

Kratom Use in the U.S.

Kratom is a tropical tree (Mitragyna Speciosa) native to Southeast Asia with opiate-like properties. Although the FDA has not approved any use of kratom, it is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression as well as opioid use disorder and withdrawal. An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the National Survey on Drugs Use and Health.

Introduction Of The Federal Kratom Consumer Protection Act

In June 2023, Congress introduced H.R.5905, the Federal Kratom Consumer Protection Act. This bill required the FDA to hold a hearing and establish a task force on the health and safety of kratom products. It also prohibited the FDA from regulating kratom products in a more restrictive manner compared to regulations for food, dietary supplements or dietary ingredients.

Earlier this month, the FDA announced its intention to initiate a 60-day public comment period on a proposed study aimed at understanding the risks and benefits of kratom and various psychedelic substances. The study required clearance from the White House Office of Management and Budget (OMB) before proceeding. However, in a recent reversal, the FDA pulled the proposal without providing a detailed explanation, stating only that “circumstances occurred necessitating changes to the scope of the study.”

Controversial Proposal

The FDA's initial proposal drew immediate backlash, especially from the American Kratom Association (AKA) and other stakeholders. Critics argued that the FDA’s approach reflected an ongoing bias against kratom, which is currently legal at the federal level as most psychedelics remain classified as Schedule I substances under the Controlled Substances Act. Mac Haddow, senior fellow of public policy for the AKA, voiced strong opposition to the FDA’s methodology, calling it “a charade” intended to validate predetermined outcomes rather than genuinely seeking public input.

Haddow expressed concern that the FDA’s decision to study these two distinct classes of substances together was an attempt to create a false equivalency between them. He suggested that the agency's actions amounted to “guilt by association,” linking kratom, which many users claim has therapeutic benefits, with psychedelics, which are heavily regulated and stigmatized despite emerging research supporting their potential mental health benefits.

Advocates Push Back

Advocates for both kratom and psychedelics have long accused the FDA of resisting harm reduction approaches that do not align with traditional drug approval frameworks. In response to the FDA’s now-withdrawn request, Haddow stated, “FDA has once again shown its clear bias against any harm reduction tool that does not fit into a new drug application model.”

The FDA's recent actions are seen by some as part of a broader pattern of skepticism towards substances like kratom and psychedelics, despite growing public interest and scientific research into their potential benefits. The agency had previously cited kratom's pharmacological similarities to opioids as a public health concern, though advocates argue that such comparisons are misleading and fail to account for the nuanced ways in which kratom is used.

Ongoing Debate And Future Implications

Just days before FDA's rejection on MDMA for PTSD treatment, this reversal leaves more questions about the future of kratom and psychedelic research in the U.S. While the agency has not provided specific reasons for withdrawing the study request, the move has been interpreted by some as a victory for advocates pushing back against what they see as unwarranted regulatory overreach.

Cover image made with Ai