DoJ sues company for selling unapproved drugs and supplements

The US Department of Justice (DoJ) has asked for an injunction to stop a Louisiana-based drug and dietary supplement manufacturer from distributing misbranded and unapproved new drugs and dietary supplements.

Filed at the US District Court for the Western District of Louisiana on Thursday, February 16, the lawsuit accused Pick and Pay/Cili Minerals and its owner of violating the Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing numerous dietary supplements.

The case was filed at the request of the Food and Drug Administration (FDA).

The marketed drugs and supplements were intended to treat or prevent serious conditions such as cancer and cardiovascular diseases, but had not been submitted to the FDA for approval.

In a statement, the DoJ said: “[The drugs] had never been found to be safe and effective for the medicinal uses claimed by defendants.”

Pick and Pay allegedly also violated the FDCA by failing to manufacture products in accordance with the FDA’s current good manufacturing practice regulations.

The regulations require manufacturers to have a system in place to ensure that their products meet specifications for identity, purity, strength and composition.

Chad Readler, acting assistant attorney general of the DoJ’s civil division, said: “Dietary supplement manufacturers endanger public health when they make unsupported claims about unapproved drugs.”

He added that the DoJ and FDA will continue to work together to protect the public from “unapproved, adulterated and misbranded products”.

Pick and Pay has agreed to settle the litigation and will be enjoined from distributing the misbranded and unapproved drugs and supplements.

The defendants will also have to recall and destroy the drugs and supplements.

Stephanie Finley, US attorney for the Western District of Louisiana, said: “Consumers deserve to know that the dietary supplements they ingest are safe and comply with the law.”