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The United States has filed a civil complaint against Port Washington-based Confidence USA Inc., its president Helen Chian and manager Jim Chao in an effort to prevent the distribution of supplements in violation of federal law. The company distributes more than 50 dietary supplements under various names such as American Best, USA Natural and The Herbal Store.
According to the complaint, the DOJ is seeking a permanent injunction to prevent Confidence USA from marketing dietary supplements without following current “good manufacturing practices." It is alleged that multiple inspections by the FDA repeatedly showed that the company failed to verify ingredients used in the manufacturing of their supplements.
The company also allegedly failed to verify to ensure that their products met specifications for purity, strength, composition and contamination limits. The complaint states that Conference USA has been issued warning letters from the FDA and U.S. Marshals have seized Conference USA products in connection to a complaint alleging that the products were adulterated.
“Millions of Americans take dietary supplements and trust that these products are safe,” U.S. Attorney Richard Donoghue of the Eastern District of New York - where the complaint was filed - stated. “This Office is committed to protecting those consumers and holding dietary supplement manufacturers and distributors to current safety standards. Today’s filing demonstrates that we will take action to enforce those standards and keep the public safe.”
Officials noted that “dietary supplements not prepared, packed and held in conformance with good manufacturing practices regulations are adulterated in violation of the Federal Food, Drug, and Cosmetic Act.
“Ensuring product integrity is a priority for the FDA,” Melinda Plaisier, Associate Commissioner for Regulatory Affairs at the FDA said in a statement. “Consumers should be able to expect that the dietary supplements they purchase meet quality standards and contain only what they are supposed to, in the correct amounts. The FDA will continue to take swift action against companies that sell adulterated dietary supplements.”
Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division added, “dietary supplement makers put consumers’ health at risk by distributing products without first verifying that those products actually are what they claim to be. The Department of Justice will continue to work with the FDA to make sure that dietary supplement manufacturers meet the legal standards necessary to ensure the quality of such products.”
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