WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced that it sent seven warning letters to companies recently for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1.
The FDA issued warning letters to Shaman Botanicals, LLC; My Smoke Wholesale; Relax Relief Rejuvenate Trading, LLC; Thang Botanicals, Inc.; Royal Diamond Imports, Inc.; Hydroxie, LLC; and 7Tabz Retail, LLC.
FDA said it is concerned over 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.
FDA made it clear that 7-OH is not lawful in dietary supplements and cannot be 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. The agency warned that 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.
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