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.
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).
In June 2015, the FDA and the Federal Trade Commission sent a joint warning letter to Innovative BioDefense about the Zylast products.
“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.
The Justice Department filed the complaint in U.S. District Court for the Central District of California at the request of the FDA.
“Consumers deserve confidence that the drugs they use are safe and effective,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to ensure that manufacturers do not circumvent the drug approval process.”
The defendants distribute their Zylast products through the internet directly to consumers. According to the complaint, the Zylast website, www.zylast.com, features a “Buy Now” button that links consumers to a second website, zylastdirect.com, where customers can purchase the products. The complaint further alleges that the Zylast products are misbranded because the second website contains the false and misleading claim that FDA considers Zylast’s active ingredient “safe and effective in open wounds” and “safe and effective for first aid” when FDA has not made such determinations.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.