August 3, 2015
Three Wisconsin companies that manufactured dietary supplements have ceased operations under an agreement that was reached with the federal government.
The U.S. Justice Department on July 31 announced filing a complaint in federal court against Atrium Inc., Aspen Group Inc. and Nutri-Pak of Wisconsin Inc., and the companies’ owners, James F. Sommers and Roberta A. Sommers. In conjunction with the complaint, the defendants have agreed to enter a consent decree of permanent injunction that is awaiting court approval. The Wautoma, Wisconsin-based defendants must conclude their business and cannot resume operations unless FDA determines that their manufacturing practices comply with the law, according to a Justice Department news release.
The three businesses have already closed, Nutri-Pak revealed in a message left on its voicemail. The companies sold dietary supplements to retail stores, healthcare professionals and to consumers through the Internet.
The government alleged the defendants failed to comply with cGMPs (current Good Manufacturing Practices), which, for instance, require manufacturers establish specificiations to ensure the identity and potency of dietary supplement ingredients. The products also were misbranded because they failed to identify the part of the plant from which the ingredients originated, neglected to list the number of servings per container, and failed to identify the serving size, the complaint alleged.
The companies did not immediately respond to a request for comment.
“Makers of dietary supplements who do not follow the FDA’s regulations put the public at risk," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, in a statement. “The Department of Justice will continue to work with the FDA to try to make sure that consumers are ingesting safe products and are getting what they paid for."
The complaint marks at least the 16th case since the fall of 2010 in which dietary supplement firms have been subject to a permanent injunction after being accused of violating federal regulations.
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