Editor's Note
The U.S. Department of Justice filed a civil complaint seeking a permanent injunction against defendants Confidence USA Inc., the company’s president, and the company’s manager to prevent them from marketing dietary supplements without following cGMPs. The complaint alleges that multiple inspections by 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. Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division said, “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.” The complaint comes after a 2011 warning letter, a 2012 seizure, and multiple establishment inspections.
The United States filed a civil complaint to stop a Long Island company from marketing adulterated dietary supplements, the Department of Justice today announced. 

The complaint, filed May 23, seeks a permanent injunction against defendants Confidence USA Inc., of Port Washington, New York, company president Helen Chian, and company manager Jim Chao 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.

According to the complaint, 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 Justice Department filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA.

“Dietary supplement makers put consumers’ health at risk by distributing products without first verifying that those products actually are what they claim to be,” said 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.” 

“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.”

“Ensuring product integrity is a priority for the FDA,” said, 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.”

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. U.S. Marshals previously seized certain Confidence USA products in connection with a 2012 complaint alleging that the products were adulterated.
A complaint is merely 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 the Assistant United States Attorney Robert Schumacher 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 .