FDA WARNING_LETTER - Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ - June 25, 2025

Thang Botanicals, Inc., operating as 7ΩHMZ, received a warning letter from the FDA dated June 25, 2025, following inspections of their facilities. The letter addresses significant regulatory violations concerning their dietary supplement products, specifically the 7OHMZ Tropic Thunder Kratom Shot, 7OHMZ 14 mg 7-Hydroxymitragynine Tablets, and 7OHMZ 7-Hydroxymitragynine Gummies. The primary issue is the inclusion of 7-hydroxymitragynine (7-OH) in these products, which the FDA has not evaluated for safety.

The FDA has identified several concerns: 7-OH products have not been approved for safe use, adverse events have been reported, and 7-OH exhibits opioid-like effects. The FDA classifies 7-OH as an unsafe food additive under the Federal Food, Drug, and Cosmetic Act because it lacks premarket approval and is not generally recognized as safe (GRAS). Consequently, products containing 7-OH are deemed adulterated, making their introduction into interstate commerce illegal.

The FDA requires Thang Botanicals to cease the distribution of these products and address the safety concerns associated with 7-OH. The company must ensure compliance with the Act by removing unapproved additives and providing evidence of safety for any new dietary ingredients. Failure to comply could result in further regulatory action, including product seizures or injunctions. The FDA emphasizes the potential appeal of these products to children and the associated risks, urging the company to take immediate corrective measures.