No Confidence In These Dietary Supplements
A federal judge entered a permanent injunction order against dietary supplement maker Confidence USA Inc., and two of its top executives.
The permanent injunction, issued Thursday by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York, bans the company and its president, Helen Chian, and general manager and founder, Jim Chao from “manufacturing, holding, or distributing any articles of food, including dietary supplements” until the Food and Drug Administration gives its approval, according to the FDA.
“Consumers deserve access to dietary supplements that are manufactured to assure their quality,” said Judy McMeekin, Pharma D, the FDA’s associate commissioner for Regulatory Affairs in a statement. “The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law.”
Confidence USA Inc. did not respond to an email request for comment.
Confidence USA Inc., based in Port Washington, N.Y., makes and distributes over 50 dietary supplements under several brand names including Confidence USA, American Best, USA Natural and The Herbal Store. Its products are sold through Amazon, Walmart and on its own website.
The decision stems from a 2019 civil complaint filed by the U.S. Justice Department against the company, Chian and Chao. It alleged that multiple FDA inspections showed that the defendants repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements. The inspections also found that Confidence USA Inc. also did not verify that its products met specifications for purity, strength, composition and contamination limits.
The FDA, under the Federal Food, Drug, and Cosmetic Act, regulates the packaging and preparation of dietary supplements. According to the Justice Department complaint, the company has had issues complying with the law. In 2011, the FDA issued a warning letter to Confidence USA regarding deficiencies at the company. In 2012, United States marshals seized certain products that were alleged to be adulterated.
Under the permanent injunction, the company cannot begin operating until it hires an independent expert to ensure it meets all Current Good Manufacturing Practices (CGMP), besides receiving FDA approval to resume operations.
Robert Calandra is an award-winning journalist and book author who has written extensively about health and medicine. His work has appeared in national and regional magazines and newspapers.