FDA News Release
Alkaloid known as 7-OH is not a lawful dietary supplement, food additive, or ingredient in any approved drug
- For Immediate Release:
The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the Agency’s 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. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.
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.
The warning letters address the illegal marketing of products containing 7-OH. These letters specifically focus on products containing 7-OH as an added ingredient or enhanced levels of 7-OH. Some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard. Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety.
The FDA issued warning letters to:
The letters requested that the recipients respond within 15 business days.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
