Confidence USA Inc., Distributing Adulterated Dietary Supplements, New York 2019

A federal court has permanently enjoined a New York company and its operators from manufacturing or distributing dietary supplements unless and until they comply with the law.

A complaint filed May 23, 2019, alleged that Confidence USA Inc., company president Helen Chian, and company 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.

“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.”

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.

The injunction was issued after the Justice Department filed the complaint in U.S. District Court for the Eastern District of New York at the request of the FDA. The government alleged that the defendants made and distributed adulterated dietary supplements in violation of the FDCA.

Dietary supplements not prepared, packed and held in conformance with current good manufacturing practices 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.

Defendant: Confidence USA Inc.

Criminal Charges: Distributing adulterated dietary supplements

City and State: New York

Exact Date: May 23, 2019

Sentence or Outcome: Permanent injunction

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