CENTRAL ISLIP, N.Y. - The United States filed a civil complaint against defendants Confidence USA Inc., of Port Washington, New York, the company’s president Helen Chian, and manager Jim Chao to prevent the distribution of adulterated dietary supplements in violation of federal law, the Department of Justice announced today. The defendants make and distribute more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural and The Herbal Store.
The complaint, filed in U.S. District Court for the Eastern District of New York, seeks a permanent injunction to prevent the defendants from marketing dietary supplements without following current good manufacturing practices (cGMPs). The complaint alleges that multiple inspections by the U.S. Food and Drug Administration (FDA) repeatedly showed that the defendants failed to verify the identity of each dietary ingredient used in the manufacture of their supplements, and also failed to verify that their products met specifications for purity, strength, composition and contamination limits.
Dietary supplements not prepared, packed and held in conformance with cGMP regulations are adulterated in violation of the Federal Food, Drug, and Cosmetic Act. According to the Department of Justice’s complaint, FDA issued a warning letter to Confidence USA in 2011 regarding deficiencies at the company. United States Marshals previously seized certain Confidence USA products in connection with a 2012 complaint alleging that the products were adulterated.
“Millions of Americans take dietary supplements and trust that these products are safe," stated United States Attorney Richard P. Donoghue of the Eastern District of New York. “This Office is committed to protecting those consumers and holding dietary supplement manufacturers and distributors to current safety standards. Today’s filing demonstrates that we will take action to enforce those standards and keep the public safe."
“Dietary supplement makers put consumers’ health at risk by distributing products without first verifying that those products actually are what they claim to be," stated Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure that dietary supplement manufacturers meet the legal standards necessary to ensure the quality of such products."
“Ensuring product integrity is a priority for the FDA," stated Melinda Plaisier, Associate Commissioner for Regulatory Affairs at the Food and Drug Administration. “Consumers should be able to expect that the dietary supplements they purchase meet quality standards and contain only what they are supposed to, in the correct amounts. The FDA will continue to take swift action against companies that sell adulterated dietary supplements."
A complaint is a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
The case is being handled by Trial Attorney Douglas Ross of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant United States Attorneys Robert Schumacher and John Vagelatos from the U.S. Attorney’s Office for the Eastern District of New York, and Associate Chief Counsel for Enforcement Jennifer Argabright of the FDA’s Office of General Counsel.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of New York, visit its website at https://www.justice.gov/usao-edny.
E.D.N.Y. Docket No. 19-CV-3073 (JMA)
Source: U.S. Department of Justice, Office of the United States Attorneys
