SANTA ANA (CNS) - A federal judge in Santa Ana ordered a Lake Forest hand sanitizer maker to stop making claims its product killed specific germs or gets FDA approval to advertise the claims, prosecutors said today.
U.S. District Judge David Carter on Monday enjoined Innovative BioDefense Inc. and its CEO Colette Cozean and distributor Hotan Barough from distributing Zylast hand sanitizer products until they receive the U.S. Food and Drug Administration approval or stop advertising on the product's labels that it kills a variety of viruses.
“American consumers rely on the FDA to ensure that their drugs are safe and effective,” said Stacy Armin, the FDA's chief counsel.
“When we cannot achieve voluntary compliance, we are fully committed to working with the Department of Justice to take appropriate action against those that subvert FDA requirements and jeopardize the health of Americans.”
Carter, however, pointed out that the top brand in the market, Purell, makes many of the same claims.
The company's attorneys argued that the case was brought at the urging of GOJO Industries, the maker of its main competitor, Purell.
Carter, however, ruled that while the “FDA's lack of enforcement against much bigger players in the market seem suspect, these facts do not remedy the fact that (Innovative BioDefense) has repeatedly been in violation of the FDCA.”
Carter noted that “throughout the trial” he “admonished the FDA for its total lack of enforcement against bigger actors who are arguably causing more harm to consumers. The disparity in enforcement creates a perception of favoritism that, while not impacting this court's decision about the particular defendant before this court, may erode public confidence in the agency.”
Attorney Kirby Behre, who represents Innovative BioDefense, said the company was “happy to comply with Judge Carter's order.”