On December 2, 2025, the FDA, with the Department of Justice and U.S. Marshals Service, seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products from three Missouri firms.
Background on the Agency’s Action
The seizure follows a series of FDA activities related to concentrated 7-OH products. Earlier in July, the Agency recommended that certain 7-OH products be scheduled under the Controlled Substances Act. The FDA also issued warning letters to seven companies concerning the distribution of various 7-OH formulations, including tablets, gummies, drink mixes, and shots. In addition, the Agency has published informational materials for healthcare professionals and consumers addressing concentrated 7-OH products.
FDA’s Stated Priorities
The FDA has indicated that its enforcement efforts are focused on concentrated 7-OH products and that it is not currently prioritizing actions related to natural kratom leaf products. As part of the December announcement, FDA Commissioner Marty Makary indicated that the enforcement action reflects the Agency’s approach to addressing concentrated 7-OH products.
For additional information regarding the FDA’s announcement, please contact the authors. Venable’s Food and Drug Law team is monitoring updates related to this issue.