WASHINGTON, D.C. ( TheStreet) -- The U.S. Food and Drug Administration is demanding that a licensee of Oculus Innovative Sciences (OCLS - Get Report) stop marketing a wound-cleansing product containing common diluted bleach as a pathogen-killing drug.
FDA sent a warning letter to Union Springs Pharmaceuticals on May 23 accusing the company of making misleading claims about MyClyns Personal Protection Spray. Union Springs peddles MyClyns to law enforcement agencies, fire departments and emergency medical responders for use as an antimicrobial agent after exposure to hepatitis C, HIV, MRSA and other dangerous pathogens.
But MyClyns only has FDA clearance as a simple medical device used to clean and moisten wounds. By claiming MyClyns can prevent infection from potentially dangerous pathogens, Union Springs is "misbranding" the product as a drug in violation of federal law, FDA says.
"We are not aware of sufficient evidence that shows MyClyns Personal Protection Spray is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from Human Immunodeficiency Virus (HIV), Hepatitis C, or MRSA after exposure to blood or other bodily fluids," the FDA warning letter states.Union Springs sells MyClyns under a license granted by Oculus Innovative Sciences, owner of the wound-cleansing product. Oculus sells the same product under other various brand names including Microcyn. Oculus makes similar drug-like claims about Microcyn, including the following description found on the company's web site: "Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores; increase blood flow to the wound site; and reduce both inflammation and pain while assisting in faster wound closure." Oculus spokesperson Dan McFadden defended the way Oculus markets Microcyn. "Internally, all our wound care and dermatology products marketed in the U.S. are fully compliant with FDA-cleared claims." McFadden did not explain how the drug-like claims Oculus makes about Microcyn are different or compliant with FDA while those made by Union Springs about MyClyns are not. McFadden added that Oculus is aware that "Union Springs is working with the FDA to resolve their issue. We are on standby to help our partners if they need assistance."