3 Dietary Supplement Companies Instructed to Stop Production

A permanent injunction has been issued by a federal judge against 3 dietary supplement companies.

A permanent injunction has been issued by a federal judge against 3 dietary supplement companies.

The Wisconsin companies will not be allowed to manufacture or sell dietary supplements until the FDA has found the businesses to be compliant with federal manufacturing regulations and other requirements.

The federal court order signed on August 4, 2015, involves Atrium Inc, Aspen Group Inc, Nutri-Pak of Wisconsin Inc, and their owners, James F. and Roberta A. Sommers.

According to the complaint, the FDA inspected these 3 companies and found them to be violating current Good Manufacturing Practice regulations. For example, they allegedly failed to properly identify certain ingredients in supplements. They also failed to properly manufacture and label the products.

The products were “misbranded and adulterated” according to the Federal Food, Drug, and Cosmetic Act.

Supplements made by these businesses include: Chole-Sterin, Di-Acid Stim, Ocu-Comp, and Super-Flex (made by Atrium), Flexile-Plus (made by Aspen), and Glucobiotic Supreme and Ocu-Comp (made by Nutri-Pak).

Atrium was first notified of violations by the FDA in 2012, and follow-ups in 2013 and 2014 at the 3 companies showed continued violations.

“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 press release. “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 companies will have to destroy all their dietary supplements, hire an independent expert, and get permission from the FDA before they start operating again.