On July 15, the U.S. Food and Drug Administration (FDA) announced it sent seven warning letters to companies for “illegally marketing” products containing 7-hydroxymitragynine (7-OH).
According to FDA, there is growing concern around “novel potent opioid products” that are being marketed and sold online and in smoke shops, gas stations and corner stores. 7-OH is an alkaloid found naturally in kratom, which is a controversial ingredient because of health and safety concerns. The letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes and shots.
According to FDA, 7-OH is not legal for use in dietary supplements or conventional foods. There are also no FDA-approved drugs that contain the ingredient, and it is illegal to market any product containing it.
“Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,” FDA said in a statement.
The Natural Products Association (NPA) applauded FDA for issuing the warning letters.
“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.’ 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,” said Daniel Fabricant, PhD, president and CEO of NPA.
NPA said it is concerned about the “lack of evidence and visibility” regarding the manufacturing and safety of 7-OH products and the unknown chemicals in them, making them adulterated under federal regulations. When marketed as dietary supplements, these products “have not been the subject of a required premarket new dietary supplement 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. The laws work well when the agency exercises its will to enforce them,” Fabricant said.
For more information, visit www.fda.gov.
