Shaman Botanicals, LLC – FDA Warning Letter, Jul 15, 2025

The FDA issued a warning letter to Mr. Sanders regarding the products 7OH + Pseudoindoxyl – Green Vein – Chewable Tablets – Advanced Alkaloids (Mint Chocolate) and 7-OH Chewable Tablets – White Vein – Advanced Alkaloids (Lemon) produced by the company located at 2405 Southwest Blvd, Kansas City, MO. The inspection highlighted significant violations related to the inclusion of 7-hydroxymitragynine (7-OH) as an ingredient, which has not been evaluated by the FDA for safe use and is associated with opioid-like effects and adverse events.

The FDA identified these products as adulterated dietary supplements under the Federal Food, Drug, and Cosmetic Act (the Act), specifically sections 201(ff)(1)(F), 413(d), and 402(f)(1)(B). The inclusion of 7-OH, a new dietary ingredient, lacks adequate safety information, presenting a potential risk of illness or injury. Consequently, the introduction of these adulterated supplements into interstate commerce is prohibited under section 301(a) of the Act.

The FDA requires the company to respond within 15 working days, detailing corrective actions taken to address these violations and prevent their recurrence. Failure to comply may lead to legal actions, including seizure and injunction. The company must submit their response to Kimberly Dutzek, Compliance Officer, at the FDA"s Human Foods Program. The letter emphasizes the company"s responsibility to ensure compliance with federal regulations and address the FDA"s concerns promptly.