FDA WARNING_LETTER - Applied Nutriceuticals

This FDA Warning Letter, dated September 13, 2017, addresses Applied Nutriceuticals, Inc. regarding their product HG4UP, marketed as a dietary supplement. The core violation is the inclusion and labeling of Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) as a dietary ingredient.

The FDA asserts that Picamilon does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. It is not a vitamin, mineral, herb, botanical, amino acid, or a dietary substance for supplementing the diet, nor is it a concentrate, metabolite, constituent, extract, or combination of these. Instead, Picamilon is described as a unique chemical entity synthesized from niacin and gamma-aminobutyric acid.

Consequently, declaring Picamilon as a dietary ingredient misbrands the product under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading. The letter also states that Picamilon is not approved as a food additive, prior sanctioned for use in dietary supplements, nor is there a basis to conclude it is Generally Recognized