My Smoke Wholesale
FDA issued a warning letter to My Smoke Wholesale (Houston, TX), owned by Laila Dawoodani, regarding their '777 Jackpot Alkaloids, 18 mg tablets' product containing 7-hydroxymitragynine (7-OH), a new dietary ingredient with opioid-like effects. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because there is inadequate information to provide reasonable assurance that 7-OH does not present a significant or unreasonable risk of illness or injury. The agency cited adverse event reports and the absence of any pre-October 1994 marketing history for 7-OH as a dietary ingredient. The recipient was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (1)
7-hydroxymitragynine (7-OH)
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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