BROOKLYN, NY – The United States Court for the Eastern District of New York has permanently enjoined a New York company and its operators from manufacturing or distributing dietary supplements unless and until they comply with the law, the Department of Justice Civil Division’s Consumer Protection Branch and the United States Attorney’s Office for the Eastern District of New York announced today.
A complaint filed May 23, 2019, alleged that defendants Confidence USA Inc., of Port Washington, New York, the company’s president Helen Chian, and manager Jim Chao violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing 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 United States filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.
“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. “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.”
“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.”
“Consumers deserve access to dietary supplements that are manufactured to assure their quality. 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,” 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.”
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.
Dietary supplements not prepared, packed and held in conformance with current good manufacturing practices (cGMP) 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.
Assistant United States Attorney Robert Schumacher from the U.S. Attorney’s Office for the Eastern District of New York and Trial Attorney Raquel Toledo of the Justice Department’s Consumer Protection Branch handled the case, with assistance from Associate Chief Counsel for Enforcement Jennifer Argabright of the FDA’s Office of General Counsel.
E.D.N.Y. Docket No: 19–CV–3073 (ERK)