FDA WARNING_LETTER - Evol Nutrition Associates, Inc. - July 29, 2011

On July 13-29, 2011, the FDA inspected Evol Nutrition Associates, Inc.'s facility in Kennesaw, GA. The inspection and subsequent review of product labels, samples, and websites (www.reddawnparty.com, www.reddawndrink.com, www.evolnutrition.com) revealed multiple violations.

Several products, including "Sandman Party Powder Euphoric Drink Mix," "Sleep Walker Euphoria Awareness Enhancer," "Spark 4D Happy Caps," "GHRelease," "Zan-X Extra Relaxation," "Red Dawn Liquid," and "Mojo Nights," were identified as unapproved new drugs under Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331(d) and 355(a)]. "GHRelease," "Zan-X Extra Relaxation," and "Mojo Nights" were also deemed misbranded under Section 502 of the Act [21 U.S.C. § 352].

Specifically, "Mojo Nights" contained undeclared tadalafil and sildenafil (active ingredients in Cialis and Viagra), sulfosildenafil, sulfotadalafil, and hydroxythiohomosildenafil, all PDE-5 inhibitors. These ingredients were not marketed as dietary supplements prior to