Washington, DC—The U.S. Food and Drug Administration (FDA) recently sent seven warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine (7-OH). FDA said the letters reflect “growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores.”
About 7-OH
7-OH occurs naturally in trace amounts in kratom, but FDA’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots. The agency explained, “7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”
Some products cited in the letters are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard, FDA said, while others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety. Warning letters were issued to the following companies, which have 15 business days to respond:
NPA Applauds FDA Action on 7-OH Products
The Natural Products Association (NPA) applauded FDA’s action on 7-OH. “Based on peer-reviewed research from leading experts, highly concentrated or semi-synthetic 7-OH products pose significant public health risks and have been falsely marketed as ‘kratom,’” said Daniel Fabricant, Ph.D., President and CEO of NPA. “These 7-OH products are not legitimate ‘dietary supplements,’ and NPA encourages FDA in collaboration with the U.S. Department of Justice to take any necessary steps to swiftly remove them from U.S. commerce.”
The trade group expressed deep concerns regarding the lack of evidence and visibility regarding the manufacturing and safety of highly concentrated 7-OH products, and the unknown chemicals in them, making them adulterated under U.S. law. NPA noted that these products, when marketed as dietary supplements, have not been the subject of a required premarket new dietary ingredient notification to establish their identity and safety.
“FDA must use every tool available to remove these highly concentrated 7-OH products from the market,” Dr. Fabricant said. “The laws work well when the agency exercises its will to enforce them.”
