Los Angeles, California - The United States filed a civil complaint to enjoin a California company from distributing hand sanitizer products that are unapproved new drugs, the Justice Department announced Wednesday.
The complaint, filed June 6, 2018, seeks to enjoin defendants Innovative BioDefense, Inc., of Lake Forest, California and its President and Chief Executive Officer, Colette Cozean, from distributing “Zylast” antiseptic hand sanitizer products that qualify as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. According to the complaint, the defendants market various Zylast products as being effective against, among other things, infection by pathogens such as the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola virus, despite a lack of proof of the products’ safety and effectiveness for such uses and no approval from the U.S. Food and Drug Administration (FDA). The Zylast product line includes Zylast Broad Spectrum Antimicrobial Antiseptic, Zylast XP (Extended Protection) Antiseptic Lotion and Zylast XP (Extended Protection) Antiseptic Foaming Soap.
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.
The case is being handled by Trial Attorney Douglas Ross of the Civil Division’s Consumer Protection Branch, with the assistance of the U.S. Attorney’s Office for the Central District of California and Associate Chief Counsel for Enforcement Yen Hoang of FDA’s Office of the Chief Counsel.