Emergency rule in Florida criminalizes sale and possession of 7-OH, citing public health risks

On August 13, 2025, US Food and Drug Administration (FDA) Commissioner Marty Makary, MD, MPH released a statement¹ commending the recent actions of Florida Attorney General James Uthmeier toward restricting isolated hydroxymitragynine (7-OH) in the state.

“Today I applaud Florida Attorney General James Uthmeier’s bold efforts to protect Floridians by filing an emergency rule to classify certain concentrated forms of 7-hydroxymitragynine, also known as 7-OH, as a Schedule I controlled substance in Florida,” Makary stated. “Effective immediately, the rule makes it illegal to sell, possess, or distribute certain concentrated forms of 7-OH – a potent opioid – in the state.”

The Attorney General’s office also published a news release² on August 13, explaining that 7-OH is a naturally occurring compound found in low levels in the leaves of the kratom plant and can be synthesized into higher concentrations in various forms, including extracts, shots, and capsules, which can be marketed as wellness supplements.

The January/February issue of Nutritional Outlook³ provided a deep dive on the rise in sales and popularity of kratom, which is made from the leaves of a tropical tree (Mitragyna speciosa) native to Southeast Asia and has perceived benefits associated with energy and mood boosting. Though not legally a dietary ingredient, kratom is one of the best-selling functional ingredients, landing in the 25 top-selling functional ingredients in the mainstream multi-outlet channel, according to SPINS data from the 52 weeks ending on October 6, 2024.

Attorney General Uthmeier’s news release also noted that 7-OH products can lead to overdoses and health effects. “Due to the danger posed to the public, Florida is taking 7-OH off the shelves immediately. This dangerous substance is being marketed to teens and young adults and has a high potential for abuse and death,” stated Attorney General Uthmeier, in the release.

In a July 29, 2025, press release⁴, the FDA announced it recommended certain 7-OH products be placed under the Controlled Substances Act, clarifying that products from the leaves of the kratom plant were not being targeted, but rather the concentrated byproduct. The news release stated the products were easy to obtain from gas stations and vape shops, and that 7-OH cannot be added to conventional foods lawfully. The FDA noted that the Drug Enforcement Administration (DEA) was reviewing the recommendation, and there would be a public comment period would take place before any scheduling was finalized⁴.

In response to the FDA’s actions, the American Kratom Association (AKA) praised⁵ the Commissioner and Department of Health and Human Services Secretary Robert F. Kennedy, Jr.

“Secretary Kennedy and Commissioner Makary have shown exceptional leadership in confronting one of the most urgent public health threats related to mislabeled, manipulated psychoactive substances,” stated Mac Haddow, senior fellow on public policy for the AKA, in the press release. “These 7-OH products are not kratom. They are chemically altered substances that carry potent opioid-like effects and pose an imminent threat to consumers. This move sends a clear and long-overdue message: the safety of the American public comes first.” Haddow also noted that FDA research had demonstrated that, when used responsibly, natural kratom use had potential for harm-reduction benefits and low potential for abuse when used responsibly.

Earlier the same month, the FDA had sent warning letters⁶ to companies illegally marketing 7-OH products, specifically those with 7-OH as an added ingredient or those with increased levels⁷.

References

1. US Food and Drug Administration. Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products (accessed 2025-08-14).
2. Office of Attorney General James Uthmeier. Attorney General James Uthmeier Files Emergency Rule; Immediately Removing Dangerous 7-OH from Store Shelves https://www.myfloridalegal.com/newsrelease/attorney-general-james-uthmeier-files-emergency-rule-immediately-removing-dangerous-7(accessed 2025-08-14).
3. Krawiec, S. Kratom sees impressive sales growth despite its regulatory status and stigma https://www.nutritionaloutlook.com/view/kratom-sees-impressive-sales-growth-despite-its-regulatory-status-and-stigma (accessed 2025-08-14).
4. US Food and Drug Administration. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumer https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers (accessed 2025-08-14).
5. American Kratom Association. American Kratom Association Praises Secretary Kennedy and Commissioner Makary for Bold Action to Recommend Scheduling of Dangerous 7-OH Products, EZ Newswire https://www.eznewswire.com/newsroom/american-kratom-association-praises-kennedy-makary-7-oh-scheduling (accessed 2025-08-14).
6. Krawiec, S. FDA sends warning letters to companies selling synthetic form of compound found in kratom https://www.nutritionaloutlook.com/view/fda-sends-warning-letters-to-companies-selling-synthetic-form-of-compound-found-in-kratom (accessed 2025-08-14).
7. US Food and Drug Administration. FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine (accessed 2025-08-14).