An order of permanent injunction has been entered against Confidence USA Inc. of Long Island, New York, and the company’s president Helen Chian and general manager and founder Jim Chao by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York. The order was entered until the company “comes into compliance with federal supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.”
The defendants must cease manufacturing, holding, or distributing dietary supplements until the FDA tells them they can resume operations. The company has made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. These supplements were distributed nationwide through Walmart, Amazon, and the company’s online store.
FDA inspections found 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,” according to the news release.
If the FDA allows the company to resume operations after an inspection, they must have an independent auditor to make sure they continue to follow current food manufacturing practice (CGMP) regulations.
Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs, said in a statement, “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.”
