Alkaloid known as 7-OH is not a lawful dietary supplement, food additive, or ingredient in any approved drug
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-OHExternal 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
- 7Tabz Retail, LLC
The letters requested that the recipients respond within 15 business days.