On July 15, the U.S. Food and Drug Administration (FDA) announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH. 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, according to the FDA.
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.
“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 the Natural Products Association (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.”
The warning letters address the illegal marketing of products containing 7-OH External Link Disclaimer. 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: Shaman Botanicals, LLC; My Smoke Wholesale; Relax Relief Rejuvenate Trading, LLC dba RRR Trading or EDP Kratom; Thang Botanicals, Inc. dba 7ΩHMZ, 7-OHMZ, or 7OHMZ; Royal Diamond Imports, Inc. dba Roxytabs.com; Hydroxie, LLC; and 7Tabz Retail, LLC.
The letters requested that the recipients respond within 15 business days.
The NPA said that it 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.”
For more information, visit www.fda.gov.
