FDA Withdraws Proposal to Research the Risks of Kratom and Psychedelics, Advocates Applaud Decision

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The FDA has retracted its request to study the risks associated with kratom and psychedelics, a move that’s being celebrated by advocates who had criticized the initial proposal, viewing it as a continuation of what they perceive as FDA bias against these substances.

Kratom products.

On August 2, the FDA announced plans in the Federal Register to open a 60-day public comment period on the proposed study, pending clearance from the White House Office of Management and Budget (OMB). However, the agency unexpectedly withdrew the notice on Monday.

The American Kratom Association (AKA) applauded the announcement of the FDA’s decision to withdraw its proposal.

“The FDA has once again shown its clear bias against any harm reduction tool that does not fit into a new drug application model,” stated Mac Haddow, Senior Fellow on Public Policy with the AKA. “This is the latest embarrassing mistake driven by a few anti-kratom staff at the FDA, and it is time for Commissioner Califf to exercise direct oversight and order the Agency to reassess its biased attacks on kratom and psychedelics.”

The FDA announced its swift withdrawal of the Federal Register Notice in a new Notice published on August 9 . The FDA explained that it withdrew the study because “circumstances occurred necessitating changes to the scope of the study.

“The FDA’s few anti-kratom staff are repeatedly undermining the Agency’s credibility on harm reduction strategies,” Haddow continued. “The National Institutes on Drug Abuse is light years ahead of the FDA in identifying harm reduction tools, like kratom and psychedelics, that make a real difference in improving the health and well-being of those struggling with pain and mental health issues, including saving the lives of many who otherwise would lose their struggles.”

“It is well past the time that Commissioner Califf should convene a stakeholder meeting with leading scientists, policy experts, and consumer advocates to determine the next best steps to protect access to safely manufactured, properly labeled, and age restricted kratom products,” concluded Haddow. “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.”

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