Bioenergy, Inc – FDA Warning Letter, Jul 1, 2010

On June 14, 30, and July 1, 2010, the FDA inspected Bioenergy, Inc.'s facility. The inspection revealed that Bioenergy, Inc.'s Corvalen, Corvalen Chewable Wafers, and Corvalen M products are misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)]. The products are labeled and marketed as "medical food" but do not meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria in 21 CFR 101.9(j)(8). Specifically, no established distinctive nutritional requirement exists for the conditions (fibromyalgia, chronic fatigue syndrome, cardiovascular disease) for which the products are promoted.

Additionally, the Corvalen M product is misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] for lacking required nutrition information, including servings per container, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, protein, vitamins, minerals, and the "Percent Daily Values" footnote, as per 21 CFR 101.9.