FDA WARNING_LETTER - MuscleMeds Performance Technologies - April 19, 2015

This FDA Warning Letter, dated April 19, 2015, addresses MuscleMeds Performance Technologies regarding their dietary supplement product, Code Red, which lists 1,3-dimethylamylamine (DMAA) as a dietary ingredient.

The FDA asserts that DMAA is a "new dietary ingredient" requiring notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6, as there's no evidence it was marketed in the U.S. before October 15, 1994, or present in the food supply in an unaltered form. Since no notification was submitted, Code Red is deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA states there's no evidence establishing DMAA's safety; it narrows blood vessels, increasing cardiovascular resistance and potentially leading to elevated blood pressure and cardiovascular events. This lack of safety evidence also renders the product adulterated under 21 U.S.C. 342(f).

The letter also highlights that synthetically produced DMAA is not a "dietary ingredient" as defined in 21 U.S.C. 321(ff)(1), as it's not a vitamin, mineral, amino acid, herb, botanical