Justice Dept. sues Port dietary supplement manufacturer

Jessica Parks

A Port Washington-based dietary supplement manufacturer and distributor was sued by the U.S. government for violations under the Federal Food, Drug, and Cosmetic Act.

Confidence USA Inc. manufactures and distributed over 50 different dietary supplements, such as American Best, USA Natural and The Herbal Store.

A complaint filed in the Eastern District of New York last Thursday outlines Confidence USA’s repeat offenses of failing to operate in compliance with current good manufacturing practices for dietary supplements.

The company maintains its headquarters at 138 Haven Ave. in Port Washington. It also operates a retail store, The Herbal Store, in Flushing.

Helen Chian, president and chief executive officer of Confidence USA, was named a defendant in the lawsuit.

The government contends Confidence USA has failed to conduct appropriate testing to verify the ingredients used in a number of its products and failed to verify the presence of all dietary ingredients in the finished product.

The U.S. Department of Justice alleges that testing results for finished products manufactured between March 2016 and October 2017 revealed components that did not meet specifications.

“These failures demonstrate the inadequacy of defendants’ rotational testing plan,” the complaint states. “Defendants do not have scientifically valid support for their rotational testing plan to ensure that it is appropriate for its intended use.”

Other violations detailed in the complaint include Confidence USA’s failure to establish various guidelines regarding the composition and strength of finished batches of dietary supplements, quality control and laboratory control procedures that are reviewed and approved by quality control personnel.

Efforts to reach Confidence USA were unavailing.

A number of the violations were observed at multiple FDA inspections, which were conducted in 2010, 2012, 2016, 2017 and 2018.

Last year, the inspection was conducted between July 5 and August 10 and investigators documented a number of significant violations that were the same as those recorded in previous years, according to the complaint.

The lawsuit was filed in the belief that the defendants will continue to violate the Food, Drug, and Cosmetics Act “unless restrained by this Court.”

The federal government wants Confidence USA to cease all operations until it applies practices that are compliant with federal regulations as well as authorizing the FDA to inspect its place of business and all records.  The company is required to bear the costs of the inspection.

The federal government also seeks reimbursement of the costs accrued from the lawsuit, should the judge rule its favor.

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