Shaman Botanicals, LLC
FDA issued a warning letter to Shaman Botanicals, LLC (CEO Stephen Vincent Sanders II) regarding two chewable tablet products containing 7-hydroxymitragynine (7-OH) marketed as dietary supplements. FDA determined that 7-OH is a new dietary ingredient with inadequate safety information to provide reasonable assurance it does not present a significant or unreasonable risk of illness or injury, rendering the products adulterated under section 402(f)(1)(B) of the Act. The agency cited opioid-like effects, adverse event reports, and lack of pre-market safety evaluation as serious concerns. FDA warned that failure to address the violations may result in seizure and injunction, and required a written response within 15 working days.
Flagged claims (2)
7-OH Chewable Tablets – White Vein – Advanced Alkaloids (Lemon)
7OH + Pseudoindoxyl – Green Vein – Chewable Tablets – Advanced Alkaloids (Mint Chocolate)
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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