FDA WARNING_LETTER - DBM Nutrition

The FDA issued a Warning Letter to DBM Nutrition regarding its product, DBM Endurance World Championship Countess, marketed as a dietary supplement. The letter identifies a violation concerning the inclusion of Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) as a dietary ingredient on the product's labeling.

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. The FDA states Picamilon is a unique chemical entity synthesized from niacin and gamma-aminobutyric acid.

This misdeclaration causes the product to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because its labeling is false or misleading. Furthermore, Picamilon is not approved as a food additive or prior sanctioned for use in dietary supplements, and the FDA has not found a basis to conclude it is Generally Recognized As Safe (GRAS) for food use.