Three Wisconsin Supplement Manufacturers Forced to Cease Operations
A U.S. District Judge has ordered three Wisconsin dietary supplement manufacturers to cease operations due to doubts over federal compliance.
Earlier this month, Judge William C. Griesbach for the Eastern District of Wisconsin entered a consent decree of permanent injunction against Atrium Inc., Aspen Group Inc., and Nutri-Pak of Wisconsin Inc., after the U.S. Food and Drug Administration (FDA) revealed that the companies are in violation of manufacturing regulations and other requirements. James F. Sommers and Roberta A. Sommers, owners of all three companies, are also named in the court order.
The charges include 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.
"When companies violate good manufacturing practice requirements, they put consumers at risk," Melinda Plaisier, associate commissioner for the FDA's Office of Regulatory Affairs, said in a written statement. "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 companies first drew the FDA's ire in 2012, when they received a warning letter citing the company for failure to follow the FDA's current Good Manufacturing Practice regulations for dietary supplements. Follow-up inspections in 2013 and 2014 revealed no improvements had been made to the initial problems.