FDA Commissioner Applauds Florida Restriction on 7-OH Opioids

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FDA Commissioner Marty Makary, MD, MPH, released a statement on Aug. 13, 2025 commending Florida Attorney General James Uthmeier’s emergency rule filing to classify certain concentrated 7-hydroxymitragynine (7-OH) opioid drugs as Schedule 1 controlled substances in Florida. The rule makes it illegal to sell, possess, or distribute certain 7-OH drugs in the state.

“The proliferation of concentrated 7-OH products is a major concern for the FDA. I am particularly concerned with the growing availability of concentrated 7-OH products appealing to children and teenagers, such as fruit-flavored gummies, candies, and ice cream cones,” Makary said in the statement (1). “These concentrated 7-OH products have snuck into every community in America, and I'm glad to see Florida's local leaders fighting back and educating Floridian parents, law enforcement professionals, teachers and community leaders about this threat to public health. I encourage other states to act now and use common sense regulation to safeguard the well-being of our youth and Make America Healthy Again.”

Scheduling action for 7-OH products

In July 2025, FDA recommended a scheduling action to control certain 7-OH products under the Controlled Substances Act (2). A concentrated byproduct of the kratom plant, 7-OH has the potential for abuse, according to the agency, because it can bind to opioid receptors. FDA released a report about the health concerns (3) of 7-OH and how it differs from the kratom plant leaf. The agency also warned about vape and other products that contain 7-OH, calling these products a major concern for the agency, especially those that might appeal to children and teenagers. Labeling for these products might not be accurately labeled, the agency stated, and they might be disguised as kratom.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said Makary in a press release (2).“7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

Labeling changes for opioid products

FDA also announced labeling changes in July for all opioid pain medications that emphasize the risks with long-term use of these products.Data from two large FDA-required observational studies, postmarketing requirements (PMR) 3033-1 and 3033-2, provided new data on how long-term opioid use can lead to serious side effects. These data combined with public comments, medical research, and a lack of studies on the long-term effectiveness of opioids led the agency to require the safety labeling changes so that health care professionals and patients can make more informed treatment decisions.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said Makary, in a press release (4). “This long-overdue labeling change is only part of what needs to be done—we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said Health and Human Services Secretary Robert F. Kennedy, Jr., in the release. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

References

1. Makary, M.A. Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products. FDA.gov. Aug. 13, 2025. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products
2. FDA. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. Press Release. July 29, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers
3. Reissig, C. J.; et al. 7-hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat. FDA.gov.
4. FDA. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks. Press Release. July 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks