FDA Files Complaint Against Company Selling Unapproved Antiseptics Claiming to Prevent Infections
The FDA seeks a permanent injunction against a company selling unapproved hand sanitizers that claim to be effective against infections from several pathogens.
The US Food and Drug Administration (FDA) has filed a complaint in federal court against Innovative BioDefense, Inc. The complaint is related to the distribution of Zylast products, a line of topical antiseptics, which the company distributed with claims to be effective against a variety of infections such as norovirus, rotavirus, flu virus, methicillin-resistant Staphylococcus aureus (MRSA), and Ebola.
The products have not been proven as safe and effective against the diseases, nor have they been approved by the FDA. Claims that hand sanitizer can offer protection against pathogens are drug claims, and, as a result, they are regulated by the FDA.
In June 2015, the FDA sent a joint letter with the Federal Trade Commission to Innovative BioDefense regarding concerns with the product claims.
US FDA Commissioner Scott Gottlieb, MD, said in a statement: "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."
The FDA’s primary concern is that individuals exposed to pathogens are experiencing a false sense of security from the Zylast products; therefore, they are not practicing the principal methods to prevent the spread of diseases, such as frequent handwashing and the use of protective gloves and clothing.
The FDA is seeking a permanent injunction that would prevent the California-based company from manufacturing and distributing the products until the FDA approves labeling requirements. In addition to the company, Colette Cozean, the president and chief executive officer of the company was named in the complaint, which was filed in the US District Court for the Central District of California by the United States Department of Justice, at the request of the FDA.
According to the FDA, the actions committed by BioDefense Inc., are a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act.) The Zylast product line includes Zylast Broad Spectrum Antimicrobial Antiseptic, Zylast XP (Extended Protection) Antiseptic Lotion and Zylast XP (Extended Protection) Antiseptic Foaming Soap.
In a recent statement from the United States Department of Justice, Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division said: “Consumers deserve confidence that the drugs they use are safe and effective. The Department of Justice will continue to work with the FDA to ensure that manufacturers do not circumvent the drug approval process.”