U.S. files injunction against Louisiana drug, dietary supplement manufacturer
The Department filed to stop the distribution of misbranded and unapproved new drugs and misbranded and adulterated dietary supplements, the Justice Department announced.
The complaint alleged that the defendants violated the federal Food, Drug and Cosmetic Act (FDCA) by manufacturing, promoting, and distributing numerous dietary supplements that the defendants had been marketing as drugs that were intended to treat, cure, or prevent a variety of diseases such as cancer, cardiovascular disease, multiple sclerosis, and other serious conditions.
These marketing and sale efforts all involved unapproved drugs, in violation of the FDCA because the products had never been submitted to the U.S. Food and Drug Administration (FDA) for approval, and had never been found to be safe and effective for the medicinal uses claimed by defendants.
Some of the products at issue were named ADD-Ease, Bone Structure, CilZinCo, Calcium, Boron, Potassium, Cilver, Sulfur, and Germanium. The Department filed a complaint in the U.S. District Court for the Western District of Louisiana on Feb. 16, at the request of the FDA.
The complaint further alleges the defendants violated the FDCA by failing to manufacture products in accordance with FDA’s current good manufacturing practice (CGMP) regulations for dietary supplements, which require manufacturers to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition.
According to the complaint, several FDA inspections between 2012 and 2016 allegedly revealed that the defendants failed to ensure the identity, purity, strength and composition of their finished products. ■