Advanced Nutritional Supplements LLC – FDA Warning Letter, May 9, 2022

This FDA Warning Letter addresses products labeled as dietary supplements: New God of Rage, God of War, New God of Fire, Legion: Extreme Fat Burner, Laxovar: Natural Recomposition, and Uprising: Natural Testosterone Support. The letter states that introducing or delivering these products into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are adulterated dietary supplements.

The core violation is that the products contain ingredients declared as dietary ingredients (higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin) that do not qualify as such under section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)]. Since these are not dietary ingredients, they are considered non-dietary ingredients. Non-dietary ingredients are subject to food additive regulations and must be generally recognized as safe (GRAS) or approved as a food additive. The FDA states that higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin are not GRAS for their intended use in these products.

Therefore, the products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)] because they contain