The Department of Justice filed a complaint alleging that three Wisconsin dietary supplement companies violated the FDA's current good manufacturing practices (cGMPs) and were misbranding their products. The companies sell products to retail stores, healthcare professionals and directly to consumers.
The complaint alleged that the firms were violating the federal Food, Drug and Cosmetic Act (FDCA) by failing to establish specifications to ensure the identity and potency of the ingredients in dietary supplements. The complaint also alleged that the products were misbranded because they did not identify the part of the plant from which the ingredients were derived, list the number of servings per container or identify the serving size. The supplements at issue included Atrium brands Chole-Sterin, Di-Acid Stim, Ocu-Comp and Super-Flex; Aspen brand Flexile-Plus; and Nutri-Pak brands Glucobiotic Supreme and Ocu-Comp.
The government also announced that the defendants agreed to settle the litigation and be bound by a consent decree that prohibits them from violating the FDCA. The consent decree requires the manufacturer to cease all operations. If the defendants wish to resume manufacturing in the future, the FDA first must determine that their manufacturing practices have come into compliance with the law. The settlement requires court approval.