The Food and Drug Administration (FDA) was largely victorious Wednesday in its bid to require dietary supplement manufacturer Confidence USA to halt its business until it retains an expert to ensure it is in line with FDA regulations governing dietary supplements. Judge Edward R. Korman of the Eastern District of New York declined to require Confidence USA to recall all of its products, a move that the company says would cause it to shut down.
The FDA brought suit against the company in May 2019, after finding the defendants in violation of “current good manufacturing practices (cGMP)” regulations. Specifically, inspections carried out by the plaintiff reportedly revealed “that defendants failed to properly establish criteria for determining the identity and purity of the ingredients in their products” and “testing methods that defendants used were inadequate to verify that the ingredients in defendants’ supplements were what they purported to be.”
The judge supported an injunction that would require the defendant to retain a regulatory expert to continue operations, and allow the FDA to carry out inspections without notice and again cease operations if a violation is found. However, the judge stopped short of approving the agency’s demand that Confidence USA recall all of its products issued in the last three years, the same as the shelf-life of the products. The defendant said this would cost over $3 million.
The judge also explained that an executive with a consulting company that has been guiding Confidence USA in recent years credibly argued that there is no need to recall and destroy outstanding product from the defendant.
The FDA weighed in via press release. “Consumers deserve access to dietary supplements that are manufactured to assure their quality. If a dietary supplement company repeatedly fails to comply with good manufacturing practice requirements, the public cannot trust that their products are what they say they are,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. “The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law.”
The defendant was represented by The Law Firm of Hugh H. Mo.