Florida Bans Sale of 7-OH and Introduces New Emergency Regulations
This past 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.
On the heels of the FDA’s pronouncements, Florida Attorney General (AG) James Uthmeier announced an emergency rule on August 13th 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. Florida has become the first state to directly target 7-OH products. AG Uthmeier indicated that enforcement efforts would begin in earnest on August 14th.
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 in order to curtail its abuse by Florida's children, young adults, and others. AG Uthmeier 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.
Per the AG’s Emergency Rule 2ER25-1, 7-OH concentrated at a level of 1 % by total weight is now classified as Schedule I drug pursuant to Florida’s Controlled Substances Act. On September 18th, the Florida Department of Agriculture adopted its emergency rules pertaining to the labelling of kratom products containing 7-OH. Per 5KER25-4, Kratom Products, must now declare on the label the concentration “7-OH” and each of its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, expressed in parts per million (PPM) on a dry-weight basis, of the net contents of the package. Note, this rule took effect on September 18, 20025 and expires on December 17, 2025.
We expect there to be movement in the 7-OH space in the Florida legislature over the coming months. Likewise, we expect the Department of Agriculture’s labelling rules to be open for notice and comment.
Please reach out to Buchanan’s Government Relations team in Florida and FDA Life Sciences group. Buchanan is actively monitoring the 7-OH situation in Florida, and will keep you updated as the situation develops.