Recalls & Warnings
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Posted March 04, 2021
Federal Court Bars Confidence USA from Selling Supplements
On March 4, 2021, the FDA announced a permanent injunction has been entered, barring dietary supplement manufacturer Confidence USA Inc. and two of its executives from producing or selling products until they become compliant with current good manufacturing practices (cGMPs).
The United States Department of Justice (DOJ) first sought this injunction in May of 2019 because the company repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements and failed to verify that their products met specifications for purity, strength, composition, and contamination limits. The DOJ complaint states that the defendants — president Helen Chian and general manager Jim Chao — make and distribute more than 50 dietary supplements under brand names including Confidence USA, American Best, USA Natural, and The Herbal Store.
The permanent injunction was filed in the U.S. District Court for the Eastern District of New York, as Confidence USA is based on Long Island, NY. A spokesperson for the FDA stated, "Consumers deserve access to dietary supplements that are manufactured to assure their quality. If a dietary supplement company repeatedly fails to comply with good manufacturing practice requirements, the public cannot trust that their products are what they say they are. The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law."
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