Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products

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. 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 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. 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.

Today’s announcement comes after the FDA’s recent recommendation for a federal scheduling action to control concentrated 7-OH products under the Controlled Substances Act. The Drug Enforcement Administration is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.  

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