Department of Justice Files Complaint Against New York Company to Stop Distribution of Adulterated D

[nitpicker]

https://www.justice.gov/opa/pr/department-justice-files-complaint-against-new-york-company-stop-distribution-adulterated

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Thursday, May 23, 2019

Department of Justice Files Complaint Against New York Company to Stop Distribution of Adulterated Dietary Supplements

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.
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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.
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