The Food and Drug Administration issued seven warning letters to companies for illegally marketing products containing 7-hydroxymitragynine, the agency said on Tuesday.
The warning letters reflect the FDA’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in gas stations, smoke shops and corner stores, the agency said.
Also known as 7-OH.1, 7-hydroxymitragynine is an active metabolite of mitragynine, more commonly known as kratom, or a plant native to Southeast Asia, according to the National Library of Medicine.
While 7-OH occurs naturally in trace amounts in kratom, the FDA said its letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes and shots, which the agency said may be dangerous.
“There are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH,” the FDA said. “Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”
The FDA issued warning letters to:
- Shaman Botanicals, LLC, Kansas City, Missouri
- My Smoke Wholesale, Houston
- Relax Relief Rejuvenate Trading LLC doing business as RRR Trading or EDP Kratom, Kansas City, Missouri
- Thang Botanicals Inc., dba 7ΩHMZ, 7-OHMZ, or 7OHMZ, Ojai, California
- Royal Diamond Imports Inc., dba Roxytabs.com, Dallas
- Hydroxie LLC, Escondido, California
- 7Tabz Retail LLC, Tampa, Florida
Recipients who received the letters have 15 working days to respond.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.