 A dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any articles of food, including dietary supplements, until they come into compliance with federal dietary supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements. Today, Judge Edward R. Korman, of the U.S. District Court for the Eastern District of New York, entered an order of permanent injunction against Confidence USA Inc., of Long Island, New York, and the company's president Helen Chian and general manager and founder Jim Chao. The permanent injunction requires the defendants to cease manufacturing, holding, or distributing dietary supplements until the FDA notifies defendants that they may resume operations. "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," said Judy McMeekin, Pharm.D., FDA's Associate Commissioner for Regulatory Affairs. "The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law." Confidence USA Inc. has manufactured and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. Confidence USA Inc. currently manufactures and distributes the above-mentioned dietary supplement products through Amazon, Walmart, and its own online store at www.confidenceusa.com. The court found that defendants violated the FD&C Act because their products were prepared, packed, or held in violation of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. 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 defendants also failed to verify that their products met specifications for purity, strength, composition, and contamination limits. The court order prohibits the defendants from receiving, processing, manufacturing, preparing, packing, holding and distributing any article of food, including dietary supplements, until they hire an independent expert to ensure that they are following the CGMP regulations, and, following an inspection, receive the FDA's approval to resume operations. Following the court order, once defendants resume operations, they must retain an independent auditor to ensure that they continue to follow the CGMP regulations. . |
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