FDA WARNING_LETTER - Fahrenheit Nutrition

This FDA Warning Letter to Fahrenheit Nutrition addresses their product, Lean Efx, labeled as a dietary supplement containing 1,3-dimethylamylamine (DMAA). The FDA asserts that DMAA is a "new dietary ingredient" requiring a notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6, which was not submitted. Consequently, Lean Efx is deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA states there is no evidence establishing DMAA's safety as a dietary ingredient. It notes DMAA narrows blood vessels, increasing cardiovascular resistance and potentially leading to elevated blood pressure and cardiovascular events. Therefore, Lean Efx is adulterated under 21 U.S.C. 342(f) due to inadequate safety information.

The letter also highlights that synthetically produced DMAA is not a "dietary ingredient" as defined in 21 U.S.C. 321(ff)(1), making its inclusion in Lean Efx a violation. The introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v).

Fahrenheit Nutrition is required to take prompt action to correct these violations for Lean Efx and