Sunday, April 11, 2021

Dietary Supplements Company Ordered to Stop Distributing ‘Adulterated’ Products

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A man’s hands are seen emptying a bottle of unidentified pills in this undated file photo.
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A federal judge ordered a dietary supplements company to shutter operations and halt distribution of its “adulterated” products on Thursday.

U.S. District Judge Edward Korman issued a permanent injunction against Confidence USA Inc. of New York state, along with the company’s president Helen Chian and founder Jim Chao, according to a news release from the Food and Drug Administration (FDA). The order prevents the company from manufacturing and distributing its products until the FDA orders otherwise.

The company is said to have violated regulations on supplement manufacturing processes while repeatedly failing FDA inspections. Inspectors could not “verify the identity of each dietary ingredient used” in the supplements from 2016 to 2018, while also being unable confirm that rules on “contamination” and “purity” of the ingredients were met.

“The millions of Americans who take dietary supplements trust that they are unadulterated and meet product specifications under good manufacturing practice regulations,” acting U.S. Attorney Seth DuCharme of the Eastern District of New York said in a statement. “The injunctive relief obtained by the United States in this case protects consumers by requiring defendants to follow the law and adhere to the regulations in manufacturing and distributing dietary supplements.”

FDA Associate Commissioner for Regulatory Affairs Judy McMeekin noted that because the company failed to “comply with good manufacturing practice requirements” on multiple occasions, “the public cannot trust that their products are what they say they are.”

The company was given an FDA warning letter in 2011 over their manufacturing practices, while U.S. Marshals later seized products following a 2012 complaint that alleged the supplements were adulterated, according to the Department of Justice (DOJ). The complaint that led to Thursday’s ruling was filed in May 2019.

“American consumers expect dietary supplements to contain the ingredients stated on the label, in the stated amounts,” said acting Assistant Attorney General Brian Boynton of the DOJ’s Civil Division. “The department will continue to work with the FDA to ensure that dietary supplement manufacturers follow the law.”

A look at the Confidence USA website revealed a relatively short list of products, all of which were labelled “out of stock” on Thursday evening. Several of the products included claims or suggestions of health benefits, although a disclaimer in small print at the bottom of the site said that the “statements have not been evaluated by the Food and Drug Administration” while noting that the “products are not intended to diagnose, treat, cure, or prevent any disease.”

The supplements also appear to have fetched reasonably high prices when they were available. One concoction labelled “Dr. Brain,” which purports to be a “Natural Formula for Supporting Brain Function,” was priced at $69.99 for a bottle of 30 capsules. In addition to the Confidence USA brand, the company was selling products under the brand names American Best, USA Natural and The Herbal Store. More than 50 products were available from outlets including the company website, Walmart and Amazon.

In order to potentially resume operations, which is subject to FDA approval, the company is required to retain an independent auditor that will verify whether manufacturing regulations are being maintained.

Newsweek reached out to Confidence USA for comment.

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