Florida Attorney General (AG) James Uthmeier announced an emergency rule on August 13 to immediately stop the sale of 7-OH products at a press conference held at Tampa General Hospital alongside the U.S. Food and Drug Administration Commissioner (FDA) Dr. Marty Makary. On the heels of the FDA's recent announcement regarding 7-OH, Florida has become the first state to directly target 7-OH products. AG Utheimer indicated that enforcement efforts would begin in earnest tomorrow.
In the Notice of Emergency Rule, the AG found a need to immediately place 7-Hydroxymitragynine (methyl (E)-2[(2S,3S,7aS,12bS)-3-ethyl-7a-hydroxy-8-methoxy-2,3,4,6,7,12b-hexahydro-1H-indolo[2,3-a]quinolizin-2-yl]-3-methoxyprop-2-enoate) (7-OH) concentrated at a level above 1% by total weight to Schedule I of the Florida Controlled Substances Act (FCSA) in order to curtail its abuse by Florida's children, young adults, and others. AG Utheimer noted the marketing and sale of 7-OH products in Florida present an immediate and imminent hazard to the public health, safety, and welfare which requires emergency action. In addition, the Attorney General has found 7-OH meets Florida's statutory criteria for placement as a controlled substance in Schedule I of the FCSA, alongside marijuana, heroin and LSD.
In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. In late July, the FDA announced it will begin taking steps to restrict the sale of 7-OH products. At present, there are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods. At the same time, the FDA issued a letter to health care professionals about the potential risks associated with 7-OH products, and a report to educate the public about the health concerns of 7-OH and its distinction from kratom. Further, FDA recommended 7-OH to be placed as a controlled substance in Schedule I of the federal Controlled Substances Act. FDA's recommendation will now go to the Drug Enforcement Administration (DEA), which oversees the final steps of the scheduling process. Expect DEA to issue a formal scheduling proposal and opening a public comment period in the immediate future. If finalized, the rule could affect companies selling 7-OH products and consumers in states where those products are currently legal.
We will continue to keep you updated on this matter as it develops.
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