Confidence USA, a Port Washington-based dietary supplement company received a permanent injunction from the U.S. Food and Drug Administration (FDA) on March 4, 2021, ordering them to stop manufacturing their products until they properly comply with the law.
A complaint was filed on May 23, 2019, alleging that Confidence USA’s company president Helen Chian and company manager Jim Chao violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing “adulterated dietary supplements.”
Confidence USA, which has manufactured and sold products since the 1970s has failed to comply with regulations in the past. The complaint alleged that “inspections conducted by 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 millions of Americans who take dietary supplements trust that they are unadulterated and meet product specifications under good manufacturing practice regulations,” Seth D. DuCharme Acting U.S. Attorney for the Eastern District of New York, said in a press release. “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.”
No further information was given as to what the products were allegedly contaminated with. But the complaint further stated that 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, which were sold through Amazon, Walmart as well as their own online retail store.
“American consumers expect dietary supplements to contain the ingredients stated on the label, in the stated amounts,” Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said. “The department will continue to work with the FDA to ensure that dietary supplement manufacturers follow the law.”
According to the FDCA, dietary supplements that are not packed, prepared or held in compliance with current good manufacturing practices are considered in violation. In 2011, the FDA issued a warning letter to Confidence USA stating that there were deficiencies with the companies manufacturing practices. U.S. Marshals previously seized certain Confidence USA products in connection with a 2012 complaint alleging the products were adulterated.”
Stipulations of the injunction state that the company must cease all manufacturing operations of their products and recall any products that are still currently on the market.
The company must also hire an independent expert to assist in remedying the causes for the repeat violations. All facilities owned by the company must also undergo a comprehensive inspection conducted by the FDA before the injunction can be removed.
If the defendants fail to comply with the stipulations of the injunction they will be required to pay “$7,500 in liquidated damages for each day the violations continue, an additional sum of $7,500 in liquidated damages per day per violation for each 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.”
“Consumers deserve access to dietary supplements that are manufactured to assure their quality,” Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs said in a statement. “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.”
The Port Washington News made several attempts to contact Confidence USA for comment regarding this lawsuit, but did not receive a response at the time of press.
—Additional information provided by the US Department of Justice, Office of Public Affairs