FDA Targets Kratom Derivative Amid Addiction Fears

The U.S. Food and Drug Administration is moving to restrict 7-hydroxymitragynine (7-OH), a derivative of the kratom plant that is commonly sold online and in vape stores. Citing concerns that 7-OH has opioid-like effects and could be similarly addictive, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary announced plans to classify 7-OH as a Schedule I substance, putting it alongside drugs such as heroin and LSD.

This marks a sharp regulatory shift aimed at curbing the accessibility of psychoactive products that have become widely available. Though naturally found in kratom, 7-OH has been isolated and intensified by manufacturers to create gummies, tablets, and drinks marketed for pain or anxiety relief. While many users report benefits, health officials warn these products may cause addiction and health complications.

Enforcement has already begun, with warning letters sent to manufacturers and more actions expected. Some researchers and consumers are calling for additional study rather than prohibition, but federal officials say urgent action is needed to prevent a possible repeat of the opioid epidemic.

Last year, Georgia enacted kratom regulations of its own, which, among other things, prohibit sales to anyone under 21 and limit the concentration of 7-OH in kratom products sold in Georgia. More comprehensive regulations were set forth in another bill during the 2025 legislative session, but that bill (HB 757) did not pass.

The attorneys at Chilivis Grubman represent clients of all types and sizes in connection with state and federal regulatory affairs and are actively assisting clients on this issue.  If you need assistance with such a matter, please contact us today.