June 7 (UPI) — The U.S. Food and Drug Administration is seeking a permanent injunction against a company that sells unapproved antiseptics, including hand sanitizers, that claim to prevent infections from numerous pathogens.
The U.S. Justice Department filed a civil complaint Wednesday on behalf of the FDA in U.S. District Court for the Central District of California to prevent Innovative BioDefense, Inc. from selling Zylast topical antiseptics. Colette Cozean, president and CEO of the company in Lake Forest, Calif., is also named as a defendant.
The FDA said in a release Wednesday the sanitizers have not been proven to be safe and effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus and Ebola. Because they are drug claims, the FDA regulates the 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,” Dr. Scott Gottlieb, the FDA’s commissioner, said. “We’re concerned that people potentially exposed to pathogens may use these products with a false sense of safety.
Gottlieb noted safe hygiene might be bypassed in favor of the products, which include antiseptic lotions, handwashes and hand sanitizers,
“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,” Gottlieb said.
On its website, the company says: “This proprietary blend of synergistic ingredients that is water-based, non-greasy and persistent for 6 hours is what became the answer to the age-old problem of hand sanitation: Zylast.”
In 2015, the FDA and the Federal Trade Commission jointly sent a warning letter to Innovative BioDefense about the Zylast products.