A federal judge issued an injunction against nutritional supplement maker Confidence USA Inc. and two of its top executives.
The standing order, issued Thursday by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York, prohibits the company and its President Helen Chian and General Manager and Founder Jim Chao from making, holding or distributing of foods, including dietary supplements, “until the Food and Drug Administration grants approval, according to the FDA.
“Consumers deserve access to supplements that are made to ensure their quality,” said Judy McMeekin, Pharma D, FDA’s Associate Commissioner for Regulatory Affairs, in a statement. “The FDA will continue to protect American consumers by taking appropriate action when companies break the law.”
Confidence USA Inc. did not respond to an email request for comment.
Confidence USA Inc., based in Port Washington, NY, manufactures and sells over 50 nutritional supplements under various brand names, including Confidence USA, American Best, USA Natural, and The Herbal Store. The products are sold through Amazon, Walmart and on their own website.
The ruling stems from a 2019 civil action brought against Chian and Chao by the US Department of Justice. It was alleged that multiple FDA inspections revealed that the defendants repeatedly failed to verify the identity of every ingredient used in the manufacture of their supplements . The inspections also revealed that Confidence USA Inc. also failed to verify that its products met specifications for purity, strength, composition, and contamination limits.
The FDA regulates the packaging and preparation of dietary supplements in accordance with the Federal Law on Food, Drugs and Cosmetics. According to the Justice Department’s complaint, the company had problems complying with the law. In 2011, the FDA issued a warning letter to Confidence USA regarding deficiencies in the company. In 2012, U.S. marshals seized certain products that were alleged to be adulterated.
As part of the standing order, the company cannot commence business unless it engages an independent expert to ensure that all current Good Manufacturing Practices (CGMP) are being followed. It also receives FDA approval to resume operations.
Robert Calandra is an award-winning journalist and author who has written extensively on health and medicine. His work has been published in national and regional magazines and newspapers.