Louisiana manufacturer hit with permanent injunction to stop distribution of adulterated supplements
The injunction, filed in the US District Court for the Western District of Louisiana on February 16 at the request of the FDA, also covers the company’s owner and CEO, Anton S. Botha.
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. Some of the products at issue were named ADD-Ease, Bone Structure, CilZinCo, Calcium, Boron, Potassium, Cilver, Sulfur, and Germanium.
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. 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, according to the complaint.
“Dietary supplement manufacturers endanger public health when they make unsupported claims about unapproved drugs,” said Acting Assistant Attorney General Chad Readler of the Justice Department’s Civil Division. “The Department of Justice and FDA will continue to work together to protect the public from unapproved, adulterated and misbranded products, and to ensure that dietary supplement manufacturers furnish accurate information to consumers about the purity and contents of their products.”
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. Once entered by the court, the consent decree requires that the defendants cease all production and distribution of misbranded and unapproved new drugs and adulterated and misbranded dietary supplements, and recall and destroy their drugs and dietary supplements.
“Consumers deserve to know that the dietary supplements they ingest are safe and comply with the law,” said US Attorney Stephanie Finley for the Western District of Louisiana. “When manufacturers and distributors market and distribute misbranded and adulterated products, the Justice Department will take affirmative steps to protect consumers.”
