The Food and Drug Administration (FDA) wants Innovative BioDefense Inc., and Colette Cozean, the company’s president and chief executive officer, to stop selling Zylast topical antiseptics – hand sanitizers, hand washes and lotions that claim to prevent infections like the norovirus, rotavirus, flu, MRSA and Ebola. Not only are the claims outrageous, the products have not been proven safe or effective for these uses, the agency cautioned in a News Release.
“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.”
The Zylast products’ claims rendered them unapproved new drugs, misbranded, and in violation of the Federal Food, Drug, and Cosmetic Act. The permanent injunction seeks to prohibit Innovative BioDefense and Cozean from manufacturing, holding and distributing the products until they comply with federal law.
The FDA and the Federal Trade Commission sent a joint warning letter to Innovative BioDefense about its Zylast products. The action was also brought before the U.S. District Court for the District of California by the U.S. Department on behalf of the FDA.
The effort reflects the FDA’s continued efforts to take appropriate enforcement action against companies and individuals who market products with inappropriate or unproven claims that could potentially put consumers’ lives at risk.
Source: FDA News Release