Formulife, Inc. – FDA Warning Letter, Sep 11, 2012

On August 1-September 11, 2012, the FDA inspected Formulife, Inc./Purus Labs, Inc. in Dallas, TX. The inspection revealed several violations.

The company distributes dietary supplements, including "Fat Smack – XR Thermolipolytic," "Muscle Marinade Fresh Fruit," and "Muscle Marinade Cherry Limeade," that declare 2-amino-4-methylhexane (dimethylamylamine or DMAA) as a dietary ingredient. The FDA determined DMAA is not a dietary ingredient but an unsafe food additive, rendering these products adulterated under 21 U.S.C. § 342(a)(2)(C). Furthermore, these products violate 21 U.S.C. § 331(ll) because DMAA was approved as a drug in 1948 and was not marketed in food prior to approval. The FDA requires immediate cessation of distribution for all DMAA-containing products.

The "D-Pol" product is promoted on www.puruslabs.net with therapeutic claims (e.g., lowering blood pressure, preventing endothelial dysfunction), classifying it as an unapproved new drug under 21 U.S.C. § 321(g)(1) and § 321(p). It is also misbranded under 21 U.S.C. § 352(f)(1) due to