Evol Nutrition Associates, Inc. – FDA Warning Letter, Apr 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy, regarding their products Sleep Walker (liquid and capsule forms) and Red Dawn Liquid, which are marketed as dietary supplements.

The core violation identified is that these products list Beta-phenyl-gamma-aminobutyric acid (phenibut) as a dietary ingredient. The FDA states that phenibut does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)]. Consequently, declaring phenibut as a dietary ingredient causes the products to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling is false or misleading.

The letter emphasizes that this is not an exhaustive list of violations and that the company is responsible for ensuring full compliance with federal law and FDA regulations. Evol Nutrition Associates, Inc. is required to take prompt action to correct the violation. The company must notify the FDA in writing within fifteen working days of receipt of the letter, detailing the specific steps taken to correct the violation and prevent recurrence, including supporting documentation. Failure to comply may result in legal action, including seizure and/or injunction