WASHINGTON, D.C. (
) --The U.S. Food and Drug Administration is demanding that a licensee of
Oculus Innovative Sciences
stop marketing a wound-cleansing product containing common diluted bleach as a pathogen-killing drug.
FDA sent a
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."
The active ingredient in MyClyns and Microcyn are the same -- greatly diluted quantities of sodium hypochlorite and hypochlorous acid.
Hypochlorous acid is a weak acid formed when chlorine is dissolved in water. It is used as an oxidizer and disinfectant. This is the stuff commonly used to keep swimming pools clean. Sodium hypochlorite is known by its more recognizable moniker -- common household bleach.
FDA gave Union Springs 15 days from the receipt of the May 23 warning letter to correct the misbranding of MyClyns or face more serious legal action. The MyClyns web site has been scrubbed of the material FDA considered misleading, with many of the sections describing the product either blank or "under construction."
FDA's action against Union Springs comes two years after
first raised questions about the
Microcyn, like MyClyns, is a wound cleaner that can be bought at retail for $20 a bottle, similar to other wound-cleaning products sold commercially for years. But TheStreet report showed how Oculus was marketing Microcyn as a drug with specific medical claims that the product cures infections, accelerates wound healing and reduces inflammation in patients with serious diabetic ulcers, according to comments made by the company's CEO Hoji Alimi and CFO Bob Miller on investor conference calls.
Oculus was making these drug-like claims about Microcyn despite only having
, according to U.S. regulators.
During a presentation to investors at a conference in Sept. 2010, Oculus' Alimi flashed on the screen a gruesome photo of a gaping diabetic foot wound. The patient was
saved from having the foot amputated by treatment with Microcyn
, Alimi alleged, even though Oculus has no data nor FDA approval to make such a claim.
For the fiscal year ended March 31, 2011, Oculus reported a net loss of $7.9 million, or 30 cents a share, on total revenue of $9.8 million. That compares to a net loss of $8.2 million, or 36 cents a share on total revenue of $7.4 million in the previous fiscal year.
Oculus shares closed Wednesday at $1.78, flat since the beginning of the year.
--Written by Adam Feuerstein in Boston.
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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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