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Gluten Free Remedies LLC was cited for misbranding its dietary supplement product "Sulbutiamine Plus Brain Support" by declaring sulbutiamine as a dietary ingredient when sulbutiamine does not meet the FDA's legal definition of a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. The company's labeling violated section 403(a)(1) of the Act by making false or misleading claims, as sulbutiamine is not a vitamin, mineral, herb, botanical, amino acid, or recognized dietary substance. The FDA found that introducing or delivering this misbranded product into interstate commerce constituted a prohibited act under section 301(a) of the Act.