FDA sues Innovative BioDefense for selling unapproved sanitisers

The US Food and Drug Administration (FDA) has sued Innovative BioDefense to ban the sale of its Zylast topical antiseptics that claim to prevent infections from various pathogens.

On behalf of the FDA, the US Department of Justice filed complaints against the company and its president and CEO Colette Cozean. The lawsuit follows a warning sent to the California-based company about the Zylast products by both the FDA and Federal Trade Commission.

The company marketed its Zylast branded sanitisers as being effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-resistant Staphylococcus Aureus (MRSA) and Ebola.

According to the FDA, such claims have not been approved by the FDA, which alleged that Zylast’s products breach the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are misbranded drugs.

FDA commissioner Scott Gottlieb said: “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.

“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.

“Today’s action reflects the FDA’s continued efforts to take appropriate enforcement action against those who market products with inappropriate or unproven claims that could potentially put patients’ health at risk.”