For Immediate Release
August 4, 2015
Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.
U.S. District Judge William C. Griesbach for the Eastern District of Wisconsin entered a consent decree of permanent injunction against Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and their owners, James F. and Roberta A. Sommers.
The complaint, filed by the U.S. Department of Justice, alleges that U.S. Food and Drug Administration inspections of Atrium, Aspen, and Nutri-Pak found numerous violations of the agency’s current Good Manufacturing Practice regulations, including failure to properly identify ingredients used in certain dietary supplements, failure to qualify suppliers and failure to properly manufacture and label dietary supplements. The complaint also alleges that these violations caused the companies’ dietary supplements to be misbranded and adulterated under the Federal Food, Drug, and Cosmetic Act.
Dietary supplements manufactured by the businesses include 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 FDA issued Atrium Inc. a Warning Letter on Nov. 2, 2012, citing the company for failure to follow the FDA’s current Good Manufacturing Practice regulations for dietary supplements. Follow-up inspections of Atrium, Aspen Group and Nutri-Pak of Wisconsin in 2013 and 2014 found continued violations.
“When companies violate good manufacturing practice requirements, they put consumers at risk,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “Our goal at the FDA is to protect public health by ensuring that dietary supplements are manufactured, labeled and distributed in accordance with federal regulations.”
The consent decree requires the defendants to destroy all dietary supplements in their possession under supervision from the FDA. Before the companies can resume making or selling dietary supplements, they must hire an independent expert and defendants may not resume operations until they receive permission to do so from the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.