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Thursday, February 16, 2017

United States Files Consent Decree of Permanent Injunction Against a Louisiana Drug and Dietary Supplement Manufacturer to Stop Distribution of Misbranded and Unapproved New Drugs and Misbranded and Adulterated Dietary Supplements

The Department of Justice filed a proposed consent decree in the U.S. District Court for the Western District of Louisiana that permanently enjoins Pick and Pay, Inc./ Cili Minerals LLC (Cili Minerals), and its owner and CEO, Anton S. Botha, to stop the distribution of misbranded and unapproved new drugs and misbranded and adulterated dietary supplements, the Justice Department announced today.

 

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.

 

“Dietary supplement manufacturers endanger public health when they make unsupported claims about unapproved drugs,” said Acting Assistant Attorney General Chad A. 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. The proposed consent decree further requires that if the defendants wish to resume manufacturing drugs or dietary supplements in the future, they must implement the remedial measures set forth in the consent decree, notify FDA of the measures taken, and obtain written approval from the FDA that they appear to be in compliance with the remedial measures set forth in the consent decree and the FDCA. The proposed consent decree is currently awaiting judicial approval.

 

“Consumers deserve to know that the dietary supplements they ingest are safe and comply with the law,” said U.S. Attorney Stephanie A. 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. I want to thank the attorneys and investigators who worked so hard to keep our citizens safe.”

 

This matter was handled by Trial Attorney Christopher O’Connell of the Civil Division’s Consumer Protection Branch, with the assistance by Assistant U.S. Attorney Karen King of the U.S. Attorney’s Office for the Western District of Louisiana and Ariel Seeley of the U.S. Department of Health and Human Services’ Office of General Counsel.

 

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Western District of Louisiana, visit its website at https://www.justice.gov/usao-wdla.

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Topic: 
Consumer Protection
Updated February 16, 2017