FDA WARNING_LETTER - Core Nutritionals LLC

On April 24, 2015, the FDA issued a Warning Letter to Core Nutritionals LLC regarding their product AMP Citrate, labeled as a dietary supplement. The product's Supplement Facts panel declares 4-Amino-2-Methylpentane Citrate (DMBA) as a dietary ingredient.

The FDA determined that DMBA is a "new dietary ingredient" as defined by section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. The letter states that there is no information demonstrating DMBA was lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, nor that it has been present in the food supply as an unchemically altered food article.

Consequently, the product is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because the required new dietary ingredient notification was not submitted. Furthermore, the FDA stated there is no evidence establishing DMBA's safety when used as a dietary ingredient, leading to adulteration under the same sections due to inadequate information to