Unapproved drugs sold online and in retail locations
Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like substance. The warning letters were sent 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
While 7-OH naturally occurs in trace amounts in kratom, these products go much further, offering concentrated forms in gummies, tablets, drink mixes, and shots that pose serious health risks to consumers. Many of these products are being sold online and in retail locations such as gas stations, convenience stores, and smoke shops — all without FDA approval or oversight.
Not Legal in Supplements, Foods, or Drugs
In its letters, the FDA made it clear:
- 7-OH is not a lawful dietary ingredient and cannot be added to food or supplements.
- No FDA-approved drug includes 7-OH as an ingredient.
- Products claiming to treat pain, anxiety, or other medical conditions using 7-OH are unapproved new drugs, making their marketing illegal.
What’s the Concern?
These warning letters focus on products that either:
- Contain enhanced or added levels of 7-OH (beyond naturally occurring trace amounts in kratom),
- Are sold as dietary supplements or foods despite not meeting FDA safety standards,
- Or make unproven medical claims without undergoing proper drug approval processes.
The FDA emphasized that consumers are being exposed to substances with no proven safety or efficacy — and potentially high risk. The agency is particularly concerned about novel opioid-like compounds marketed outside the formal drug approval system.
The Bottom Line
If you see products that contain 7-hydroxymitragynine or make bold claims like “pain relief” or “anxiety control,” steer clear. These are not approved by the FDA, may pose serious health risks, and are now the subject of FDA enforcement.
As always, the FDA encourages consumers to be cautious and to report adverse events related to any supplement or drug product.