The U.S. Food and Drug Administration recently filed a complaint against Innovative BioDefense, Inc. to prohibit the company from selling its Zylast antiseptics with allegedly unproven claims that the sanitizers 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, are regulated by the FDA as drugs. According to the FDA, Zylast has not been proven to be safe and effective for its advertised uses and is 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.”
The attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully prosecuted numerous false advertising actions on behalf of consumers. If you or someone you know purchased Zylast products, including Zylast XP Antiseptic, Zylast XP Antiseptic Foaming Soap, or Zylast XP Antiseptic Lotion, to prevent serious-disease related pathogens, contact us to discuss your legal options.