Lafayette business accused of selling misbranded dietary … – The Daily Advertiser

Posted: February 17, 2017 at 1:19 am

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A Lafayette business has agreed to stop distributing several supplements when the U.S. Department of Justice filed an injunction alleging that the drugs were never approved by the U.S.Food and Drug Administration.

Theproposed consent decree, filed Thursday,permanently enjoins Pick and Pay Inc./Cili Minerals LLC and its owner and CEO, Anton S. Botha, to stop the distribution of what it calls "misbranded and unapproved new drugs, and misbranded and adulterated dietary supplements," according to a press release from the DOJ.

The complaint alleges that the companies violated the federal Food, Drug and Cosmetic Act by manufacturing, promoting and distributing numerous dietary supplementsthat had been marketed as intended to "treat, cure or prevent a variety of diseases such as cancer, cardiovascular disease, multiple sclerosis and other serious conditions."

The marketing effortswere a violation of the FDCA because the products had never been submitted to the FDA for approval, and had never been found to be safe and effective for medicinal uses, as the marketing claimed, the press release says. The complaint also alleges that the defendants violated the FDCA by failing to manufacture its products in accordance with FDA regulations for dietary supplements.

The products in question included ADD-East, Bone Structure, CilZinCo, Calcium, Boron, Potassium, Cilver, Sulfure and Geranium.

In conjunction with the filing of the complaint, the companies agreed to settle the litigation, and to cease all production and distribution of the supplements in question. The companies would be able to resume manufacturing the supplements with written approval from the FDA.

The complaint is currently awaiting judicial approval.

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