08.04.15
The Department of Justice filed a complaint on July 31 alleging that three Wisconsin companies that manufacture dietary supplements were not complying with FDA’s current good manufacturing practices and were misbranding their products.
The complaint was filed in the Eastern District of Wisconsin against Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and the owners of the three firms, James F. Sommers and Roberta A. Sommers. The companies, located in Wautoma, WI, sell dietary supplements to retail stores, healthcare professionals and directly to consumers via the Internet.
The complaint alleged that the firms were violating the federal Food, Drug and Cosmetic Act (FDCA) by failing to comply with current good manufacturing practices that, among other things, require manufacturers to establish specifications to ensure the identity and potency of the ingredients in dietary supplements. The complaint also alleged that the firms’ products were misbranded because they failed to identify the part of the plant from which the ingredients were derived, did not list the number of servings per container and failed to identify the serving size.
Supplements manufactured by the firms 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.
“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. “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.”
“This case and the remedial actions required by the consent decree reflect the continuing focus of our office and the Justice Department generally in safeguarding and promoting the health and well-being of our people,” said U.S. Attorney James L. Santelle of the Eastern District of Wisconsin. “The corrections that these companies are required to accomplish along with oversight and inspection of them, will ensure compliance with the law and responsible sales to consumers.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from violating the FDCA. The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if the defendants wish to resume manufacturing dietary supplements in the future, the FDA first must determine that their manufacturing practices have come into compliance with the law. The proposed consent decree is awaiting approval by the court.
The case is being handled by Trial Attorney Patrick Jasperse of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Susan M. Knepel of the Eastern District of Wisconsin, with assistance from Deeona Gaskin of the FDA’s Office of the Chief Counsel.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
The complaint was filed in the Eastern District of Wisconsin against Atrium Inc., Aspen Group Inc., Nutri-Pak of Wisconsin Inc., and the owners of the three firms, James F. Sommers and Roberta A. Sommers. The companies, located in Wautoma, WI, sell dietary supplements to retail stores, healthcare professionals and directly to consumers via the Internet.
The complaint alleged that the firms were violating the federal Food, Drug and Cosmetic Act (FDCA) by failing to comply with current good manufacturing practices that, among other things, require manufacturers to establish specifications to ensure the identity and potency of the ingredients in dietary supplements. The complaint also alleged that the firms’ products were misbranded because they failed to identify the part of the plant from which the ingredients were derived, did not list the number of servings per container and failed to identify the serving size.
Supplements manufactured by the firms 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.
“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. “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.”
“This case and the remedial actions required by the consent decree reflect the continuing focus of our office and the Justice Department generally in safeguarding and promoting the health and well-being of our people,” said U.S. Attorney James L. Santelle of the Eastern District of Wisconsin. “The corrections that these companies are required to accomplish along with oversight and inspection of them, will ensure compliance with the law and responsible sales to consumers.”
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from violating the FDCA. The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if the defendants wish to resume manufacturing dietary supplements in the future, the FDA first must determine that their manufacturing practices have come into compliance with the law. The proposed consent decree is awaiting approval by the court.
The case is being handled by Trial Attorney Patrick Jasperse of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Susan M. Knepel of the Eastern District of Wisconsin, with assistance from Deeona Gaskin of the FDA’s Office of the Chief Counsel.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
