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Case Number: 2:19-cv-03073-ERK-SIL
Judge: Edward R. Kormanone
Court: United States District Court for the Eastern District of New York (Kings County)
Plaintiff's Attorney: United States District Attorney’s Office
Description: Brooklyn, New York - The United States of America sued Confidence USA Inc. company president Helen Chian, and company manager Jim Chao violated the Federal Food, Drug, and Cosmetic Act (FDCA) claiming that they distributed adulterated dietary supplements.
The complaint alleged that inspections conducted by the U.S. Food and Drug Administration (FDA) in 2016, 2017, and 2018 showed that the defendants repeatedly failed to verify that their finished dietary supplements met product specifications for identity, purity, strength, composition, and contamination limits, and failed to verify the identity of each dietary ingredient used in the manufacture of the supplements. The Justice Department filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.
“American consumers expect dietary supplements to contain the ingredients stated on the label, in the stated amounts,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The department will continue to work with the FDA to ensure that dietary supplement manufacturers follow the law.”
According to the complaint, the defendants made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural and The Herbal Store.
“The millions of Americans who take dietary supplements trust that they are unadulterated and meet product specifications under good manufacturing practice regulations,” said Acting U.S. Attorney Seth D. DuCharme for the Eastern District of New York. “The injunctive relief obtained by the United States in this case protects consumers by requiring defendants to follow the law and adhere to the regulations in manufacturing and distributing dietary supplements.”
Dietary supplements not prepared, packed and held in conformance with current good manufacturing practices regulations are adulterated in violation of the FDCA. The FDA issued a warning letter to Confidence USA in 2011 regarding deficiencies with the company’s manufacturing practices, and U.S. Marshals previously seized certain Confidence USA products in connection with a 2012 complaint alleging the products were adulterated.
“Consumers deserve access to dietary supplements that are manufactured to assure their quality,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. “If a dietary supplement company repeatedly fails to comply with basic 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.”
Trial Attorney Raquel Toledo of the Department of Justice Civil Division's Consumer Protection Branch and Assistant U.S. Attorney Robert Schumacher from the U.S. Attorney’s Office for the Eastern District of New York handled the case, with assistance from Associate Chief Counsel for Enforcement Jennifer Argabright of the FDA’s Office of General Counsel.
Outcome: The court enjoined the defendants from manufacturing or distributing dietary supplements unless and until they comply with the law.