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Posted May 25, 2019

Department of Justice Files Complaint to Shut Down Supplement Company

On May 23, 2019, the United States Department of Justice announced a complaint seeking a permanent injunction has been filed against dietary supplement marketers Helen Chian and Jim Chao, president and company manager of Confidence USA Inc.

According to the complaint, the company repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements and failed to verify that their products met specifications for purity, strength, composition, and contamination limits, which are violations of current good manufacturing practices (cGMPs).

The complaint states that the defendants make and distribute more than 50 dietary supplements under brand names including Confidence USA, American Best, USA Natural, and The Herbal Store. The complaint also states that the FDA issued a warning letter to Confidence USA in 2011 regarding deficiencies at the company, and that marshals had previously seized certain Confidence USA products in connection with a 2012 complaint alleging that the products were adulterated.

The complaint was filed in U.S. District Court for the Eastern District of New York at the request of the FDA.

In the U.S. Department of Justice news release, Associate Commissioner for Regulatory Affairs at the FDA Melinda Plaisier said, "Ensuring product integrity is a priority for the FDA. 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."

See Related Warnings and Recalls:

Federal Court Shuts Down Maker of Sexual Enhancement Products

Federal Court Shuts Down Seller of Supplement Promoted for Herpes

Supplement Manufacturer Shut Down for Manufacturing Violations

Company Ordered to Stop Making and Selling Supplements

To read the full news release, use the link below.