A dietary supplement company based in Port Washington has received an injunction from manufacturing its products from the U.S. Food and Drug Administration, the U.S. Attorney’s Office for the Eastern District of New York announced March 4.
The attorney’s office cites a complaint filed May 23, 2019 alleging that Confidence, USA Inc., a Port-based company that began in the 1970s and produces vitamins and other health supplements, violated the Federal Food, Drug, and Cosmetic Act by distributing “adulterated dietary supplements.”
“The complaint alleged that inspections conducted by the [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 office said in a statement.
What the supplements were supposedly contaminated with was not disclosed. The complaint was filed in the U.S. District Court for the Eastern District of New York at the request of the FDA, and also names company president Helen Chian and manager Jim Chao.
“[The company] made and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural and The Herbal Store,” the office said in a statement. “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.”
As part of the injunction, the company must cease manufacturing it products and recall any still on the market, and its facilities must undergo a rigorous FDA inspection before the injunction is removed.
If the company fails to act on the violations, they will be fined $7,500 in liquidated damages for each day the violations continue, an additional $7,500 in liquidated damages per day per violation for each counted violation, and an additional sum in liquidated damages equal to twice the retail value of any product distributed in violation of this Order, the Act, or its implementing regulations.
“The millions of Americans who take dietary supplements trust that they are unadulterated and meet product specifications under good manufacturing practice regulations,” Acting U.S. Attorney Seth D. DuCharme said in a statement. “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.”
“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, the 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.”
Efforts to reach Confidence, USA Inc. for this story were unavailing.