FDA files complaint against company marketing unapproved hand sanitizers

Jun 7 2018

The U.S. Food and Drug Administration today filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company's president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.

"Despite being warned by the FDA about their unproven claims, this company has continued to market their products as a tool for preventing infection from serious disease-related pathogens, without adequate evidence to support these uses," said FDA Commissioner Scott Gottlieb, M.D. "We're concerned that people potentially exposed to pathogens may use these products with a false sense of safety. This may result in infrequent hand washing, or the substitution of these products for protective gloves and clothing or hand washing, which are the principal methods for protecting against the spread of diseases. Today's action reflects the FDA's continued efforts to take appropriate enforcement action against those who market products with inappropriate or unproven claims that could potentially put patients' health at risk."

The Zylast products, including antiseptic lotions, handwashes, and hand sanitizers, are unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The permanent injunction sought by the FDA would prohibit Innovative BioDefense and Cozean from manufacturing, holding, and distributing drug products until they comply with the FD&C Act and its regulations, including approval and labeling requirements.

In June 2015, the FDA and the Federal Trade Commission sent a joint warning letter to Innovative BioDefense about the Zylast products.

The action was brought before the court by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California.