FDA WARNING_LETTER - Vital Pharmaceuticals, Inc. dba VPX Sports

On April 24, 2015, the FDA issued a Warning Letter to Vital Pharmaceuticals regarding their dietary supplement products, VPX Redline White Heat and MD2 Meltdown. The letter states that these products are adulterated under sections 402(f)(1)(B) and 413(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).

The primary violation concerns the ingredient 4-Amino-2-Methylpentane Citrate, also known as DMBA, which is declared on the Supplement Facts panel. The FDA asserts that DMBA is a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. To the FDA's knowledge, DMBA was not marketed in the U.S. before October 15, 1994, nor has it been present in the food supply as an unchemically altered food article. No new dietary ingredient notification was submitted for DMBA.

Furthermore, the FDA states there is no evidence establishing DMBA's safety when used as a dietary ingredient. The letter also notes that synthetically produced DMBA is