Today, the U.S. Food and Drug Administration (FDA) announced that 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 (cGMP) 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., which is based in Long Island, NY. The permanent injunction extends to 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,” Judy McMeekin, Pharm.D, FDA’s associate commissioner for Regulatory Affairs, said. “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. The company manufactures and distributes the above-mentioned dietary supplement products through Amazon, Walmart, and its own online store.
 
The court found that defendants violated the FD&C Act because their products were prepared, packed, or held in violation of 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 manufacturing of their supplements. The defendants also failed to verify that their products met specifications for purity, strength, composition, and contamination limits.
 
In order to resume receiving, processing, manufacturing, preparing, packing, holding, or distributing any article of food including dietary supplements, the company must hire an independent expert to ensure that they are following cGMP regulations, and, following an inspection, receive FDA approval to resume operations. The defendants must also retain an independent auditor to ensure that they continue to follow the cGMP regulations.