In conjunction with a complaint, the defendants have agreed to enter a consent decree of permanent injunction.

Josh Long, Associate editorial director, Natural Products Insider

August 3, 2015

2 Min Read
Justice Department Sues Three Dietary Supplement Businesses in Wisconsin

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.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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