Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ Warning Letter Details

Summary

Thang Botanicals, Inc. (operating as 7OHMZ) manufactured and distributed dietary supplement products containing 7-hydroxymitragynine (7-OH), including Tropic Thunder Kratom Shot, 14 mg tablets, and Strawberry Acai gummies, in violation of the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were adulterated because 7-OH had not been evaluated for safe use, the agency had received adverse event reports associated with 7-OH products, and 7-OH has been reported to have opioid-like effects. The specific compliance failures included introducing products into interstate commerce that contained an unsafe food additive without FDA approval and misbranding the products through their ingredient declarations.