FDA WARNING_LETTER - Gluten Free Remedies LLC - May 20, 2025

On April 15, 2025, the FDA issued a Warning Letter (CMS #687832) to Mr. Shikhman regarding the product Sulbutiamine Plus Brain Support, labeled as a dietary supplement. The letter states that introducing or delivering this product into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act) because it is a misbranded dietary supplement.

The core violation is that the product label declares sulbutiamine as a dietary ingredient, but sulbutiamine does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. This misrepresentation causes the product to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)], as its labeling is false or misleading. The introduction or delivery for introduction into interstate commerce of any misbranded food is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].

The FDA requires a written response within 15 working days, detailing specific steps taken to address the violations, prevent recurrence, and provide supporting documentation. Failure to adequately address this matter may result in legal action, including seizure and injunction. The letter also clarifies that