FDA Issues Warning Letters in Response to Products Containing 7-OH

The U.S. Food and Drug Administration (FDA) has sent seven warning letters to companies alleging that they illegally marketed products containing 7-hydroxymitragynine (7-OH).

7-OH is an alkaloid found in trace amounts in the kratom plant, and, per the FDA, exhibits effects similar to opioids by acting on opioid receptors. The letters reflect 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. The letters also focus on concentrated 7-OH products like tablets, gummies, drink mixes, and shots.

7-OH is not lawful in dietary supplements or foods, and there are no FDA-approved drugs containing 7-OH, the FDA noted. “Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,” the agency noted.

Some of the products targeted in the series of warning letters were adulterated conventional foods, while others were considered unapproved new drugs, with unproven claims related to pain relief, anxiety, and more, the agency noted.

The brands FDA issued warning letters to include:

• Shaman Botanicals, LLC
• My Smoke Wholesale
• Relax Relief Rejuvenate Trading, LLC
• Thang Botanicals, Inc.
• Royal Diamond Imports, Inc.
• Hydroxie, LLC
• 7Tabz Retail, LLC

The Natural Products Association announced its support of FDA’s actions against the seven companies, particularly for its focus on highly concentrated products, rather than those that contain kratom leaf.

“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, PhD, 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.”

“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,” said Fabricant.

The American Herbal Products Association (AHPA) has also expressed concern about the rise of synthetic or highly-concentrated 7-OH products that are being deceptively marketed as “kratom,” and updated its membership policy to strongly discourage the marketing of such products. This guidance is consistent with a membership requirement AHPA has held since 1999, which requires the disclosure of added constituents that require separate identification in bulk raw materials or finished products.

Similarly, the American Kratom Association (AKA) issued a consumer warning last year that products which isolate, purify, or concentrate 7-OH are not real kratom products, warning that “7-OH enhanced products have a greater abuse liability and a higher risk for adverse events … 7-OH enhanced products will empower the FDA to seek another ban on kratom at the federal and state levels.”