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:
- 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
- 7Tabz Retail, LLC
The letters requested that the recipients respond within 15 business days.
- 1Also known as 7-OH-mitragynine, 7-OHMG, and 7-HMG
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