FEDS ORDER CALIFORNIA HAND SANITIZER COMPANY TO STOP MARKETING UNAPPROVED NEW DRUGS

    A federal court ordered a California company to stop distributing unapproved hand sanitizer products as new drugs. Innovative BioDefense Inc., of Lake Forest, California and company CEO Colette Cozean and distributor Hotan Barough must stop distributing “Zylast” hand sanitizer products until the company obtains U.S. Food and Drug Administration (FDA) approval or removes disease-specific claims from its product labeling.  In a 2018 complaint, the United States alleged that the defendants distributed Zylast products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).  According to the complaint, the defendants marketed their products as being effective against 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 FDA.  The court found that the defendants’ violations of the FDCA were persistent and recurrent. 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 defendants distributed their Zylast products through the internet directly to consumers.  According to the complaint, the Zylast website, www.zylast.com, featured a “Buy Now” button that linked consumers to a second website, zylastdirect.com, where customers could purchase the products.  Along with these websites, the court also found that a new webpage that IBD launched during trial, www.zylastpro.com, also contained disease-specific claims.

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