FDA WARNING_LETTER - My Smoke Wholesale - July 15, 2025

The FDA issued a warning letter to Ms. Dawoodani regarding the 777 Jackpot Alkaloids, 18 mg tablets, produced by the company located at 5750 Bintliff Drive, Suite 216, Houston, TX. The inspection highlighted significant regulatory violations concerning the inclusion of 7-hydroxymitragynine (7-OH) in the product. The FDA identified that 7-OH is a "new dietary ingredient" under section 413(d) of the Federal Food, Drug, and Cosmetic Act, and there is insufficient information to ensure its safety, classifying the product as adulterated under section 402(f)(1)(B) of the Act. The FDA expressed concerns over the opioid-like effects of 7-OH and associated adverse event reports.

The FDA requires the company to address these violations within 15 working days of receiving the letter. The company must provide a detailed response outlining corrective actions, including documentation and an explanation if the timeline cannot be met. Failure to comply may result in legal actions such as seizure or injunction. The response should be directed to Kimberly Dutzek, Compliance Officer, at the FDA"s Human Foods Program. The company is responsible for ensuring compliance with all federal laws and preventing future violations.