The FDA on June 7 filed a complaint in federal court against a company claiming its hand sanitizers and antiseptic rubs can protect against various infectious diseases, including Ebola and methicillin-resistant Staphylococcus aureus.
Here are three things to know:
1. The U.S. Department of Justice filed a permanent injunction on behalf of the FDA against Innovative BioDefense and Colette Cozean, the company's president and CEO.
2. The agency seeks to ban Innovative BioDefense from selling its Zylast topical antiseptics using claims the products offer protection against norovirus, rotavirus, flu virus, MRSA and Ebola.
"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, MD.
3. The permanent injunction would prohibit BioDefense from "manufacturing, holding and distributing drug products until they comply with the FD&C Act and its regulations, including approval and labeling requirements," according to the FDA.
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