Washington, D.C. — The Natural Products Association, the nation’s leading trade association advocating for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell these products, commends the U.S. Food and Drug Administration for seven warning letters announced today against products containing concentrated amounts of 7-OH (7-hydroxymitragynine).
“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.”
In a news release announcing the warning letters, FDA concluded 7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods, and the agency warned the products have not been proven effective or safe for any use.
NPA is deeply concerned about 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. These products, when marketed as dietary supplements, also 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,” Fabricant said. “The laws work well when the agency exercises its will to enforce them.”
