FDA Withdraws Request For White House Permission To Study Kratom And Psychedelics Risks Amid Criticism

The Food and Drug Administration (FDA) has withdrawn a request for White House permission to conduct a study about the risks of using kratom and psychedelics amid a “rapid resurgence” of public interest in the substances. Advocates are celebrating the news after criticizing the initial request as another example of FDA “bias” against harm reduction options.

In an initial notice published in the Federal Register earlier this month, FDA said it planned to open a 60-day public comment period for interested parties to weigh in on the proposed survey, which needed to be cleared by the White House Office of Management and Budget (OMB) first. But in a reversal, it withdrew the notice on Monday.

Specifically, FDA was looking for comments on “whether the proposed collection of information is necessary for the proper performance of FDA’s functions” and other logistical considerations.

“Understanding the social, behavioral, and environmental contexts and motivations for use [of kratom and psychedelics] is included in our need to protect the public’s health, through data-informed strategic initiatives,” the notice said.

Notably, the agency was soliciting public comment on a study related to use of two distinct drug categories. Kratom is currently unscheduled (i.e. federally legal), whereas many psychedelic substances are classified as Schedule I drugs under the Controlled Substances Act. Their effects are also distinct, though consumers have reported anecdotally that both classes carry therapeutic potential, including addressing substance misuse issues, for example.

“This exploratory study is intended as a strategic response to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics,” FDA had said.

“Kratom is one of the substances that make up the opioid ecosystem, suggesting that it can potentially present the risks of abuse, addiction, and misuse,” it added. “Notably, kratom’s unapproved status does not appear to have diminished its growing popularity, with people using kratom to reportedly ‘treat’ certain health conditions. Its chemical affinity with opioid and use among patients with opioids use disorder as a ‘treatment’ is of public health concern for the Agency.”

In its new notice of withdrawal, the agency didn’t explain why it changed course. Rather, it simply said “FDA no longer intends to proceed with the proposed study as described because circumstances occurred necessitating changes to the scope of the study.”

The American Kratom Association (AKA) has pushed back on the agency’s tendency to associate kratom’s pharmacological properties to opioids. And one top kratom stakeholder told Marijuana Moment that he suspected the agency’s since-withdrawn request for White House approval for a new survey reflected FDA’s ongoing interest in imposing a ban on the plant and its derivatives.

Mac Haddow, senior fellow of public policy for AKA, said the initial notice was “just a charade,” with FDA checking a box based on statutory obligations under the Paperwork Reduction Act (PRA) to formally request White House permission even though they’ve already contracted a company to complete the survey, as noted in the original Federal Register posting.

“It has nothing to do with anything other than validating what they’ve already done,” Haddow said. “This is the way the FDA does business when it comes to kratom, and it’s really unfortunate.”

Haddow separately said in a statement on Friday, when a draft version of the withdrawal notice was first posted, that “FDA has once again shown its clear bias against any harm reduction tool that does not fit into a new drug application model.”

AMERICAN KRATOM ASSOCIATION WELCOMES THE FDA WITHDRAWAL OF DEEPLY FLAWED RISK/SAFETY DATA COLLECTION AND STUDY ON PSYCHEDELIC AND KRATOM USE

The FDA’s consistent bias against valuable harm reduction tools is exposed in their latest rush to demonize products like kratom and… pic.twitter.com/Z5nK6DXVXx

— American Kratom Association (@TheKratomAssn) August 9, 2024

“This is the latest embarrassing mistake driven by a few anti-kratom staff at the FDA, and it is time for Commissioner [Robert] Califf to exercise direct oversight and order the Agency to reassess its biased attacks on kratom and psychedelics,” he said.

In February, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak also discussed the agency’s cannabis and kratom interests.

“In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom and others,” she said. “And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like?”

As FDA under the Trump administration prepared to propose federal restrictions on kratom, a number of top officials intervened, criticizing the agency’s “bias” and stopping it “on the spot” from moving ahead with scheduling, a former White House drug czar said in an interview last year.

Prior to the withdrawal of the survey request, Haddow said AKA was “surprised at the at the methodology that the FDA has utilized in order to hide the ball when it comes to kratom research, because they’ve asked for comments about a study design and the contractor that they’ve already selected.”

“The protocol for the study has already been determined,” he said. “Asking for comments about it won’t change anything along the way, but it’s not going to stop us.”

Asked about the agency’s dual request concerning both kratom and psychedelics, Haddow said it’s not just “apples to oranges,” it’s “guilt by association,” suggesting that FDA is aiming to create a narrative that the substance classes are effectively parallel, despite their scheduling differences.

“The FDA has a strong bias against psychedelics, which personally I would contest, because the evidence and data is suggesting that psychedelic medicines can have tremendous benefits,” he said. “But to try to combine a psychedelic, which is a Schedule I substance, with kratom, which is not—and, in fact, it’s a benign botanical supplement—the guilt by association is clear.”

FDA recognized in its initial notice that psychedelic substances, while Schedule I, “have recently seen a rapid resurgence with the growing interest in its use as a potential treatment for some mental health disorders.”

“Further, the increasing social acceptance of psychedelics use among certain communities in the United States may also present public health risks. Although a Schedule 1 substance, there is no FDA-approved psychedelic drug, which does not appear to have diminished the growing interest in their use,” it said. “The rapid pace of interest in psychedelics is evidenced by the number of research investigations and investigational new drug applications from certain groups.”

“Psychedelics such as LSD, MDMA, and psilocybin are especially of interest. In the backdrop of shifting State policies to either decriminalize or legalize psychedelics, suggests a potential future in which these drugs are abused or people who use them are abused because of their vulnerable state of consciousness while under the influence of the drug. Presently, there is little to no study on the co-occurrence of use of kratom and psychedelics.”

This comes as FDA faces criticism for declining to approve MDMA-assisted therapy for the treatment of conditions such as post-traumatic stress disorder after an agency advisory committee recommended against that approval earlier this year.

Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval and also launched an art installation memorializing military veterans who died by suicide.

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Photo elements courtesy of carlosemmaskype and Apollo.