FDA Issues Warning to Companies Selling Unlawful Opioid Containing Products
The FDA has issued warnings to companies selling unapproved products containing 7-hydroxymitragynine, a compound found in kratom, citing safety and regulatory violations. Learn more about these enforcement actions aimed at consumer protection.
The U.S. Food and Drug Administration (FDA) has taken action against several companies by issuing warning letters concerning the illegal marketing and sale of products containing 7-hydroxymitragynine (7-OH). This compound, which occurs in trace amounts in kratom, is not approved for use in dietary supplements, foods, or pharmaceuticals.
The FDA targeted businesses selling concentrated 7-OH products such as tablets, gummies, drink mixes, and shots both online and in retail outlets like smoke shops, gas stations, and corner stores. These products are not authorized for consumer use, and their marketing violates federal regulations. Notably, 7-OH is not permitted in any dietary supplements or conventional foods, and there are no approved medications that contain this compound.
The warning letters instruct these companies to immediately cease the illegal promotion and distribution of products containing added or elevated levels of 7-OH. Such products are deemed adulterated, unsafe, and unsubstantiated for any health claims—particularly in pain relief and anxiety management. The FDA emphasizes that consumers using these unapproved products are risking their health by taking substances unproven to be safe or effective.
Recipients of the warning include companies such as 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. All targeted companies are required to respond within 15 business days to address the violations.
The FDA’s ongoing efforts aim to protect consumers from unregulated and potentially harmful substances in the marketplace. For more detailed information, visit the FDA's official announcement at FDA Warning Letters on Kratom Products.
Source: https://medicalxpress.com/news/2025-07-fda-letters-companies-illegal-opioid.html
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