Rosenberg, Texas (August 28, 2020) - The United States Food & Drug Association (“FDA”) has recently issued warning letters to various companies concerning misleading statements regarding COVID-19 claims. These claims surrounded the use of hypochlorous acid in the prevention of COVID-19. As quoted from FDA communications:
“There are currently no FDA approved products to prevent or treat COVID-19.”
In the current issue of Optometric Management, NovaBay Pharmaceuticals, maker of Avenova®, promoted the use of its hypochlorous acid to kill COVID-19 on surfaces. Such claims of efficacy require formal review and approval by the Environmental Protection Agency (EPA) as surface disinfectants prior to being used in labeling and promotional, marketing claims. OCuSOFT Inc., also offers a hypochlorous acid spray, OCuSOFT® HypoChlor®. Both Avenova® and HypoChlor® are bactericidal and virucidal. However, we would like to reiterate, there are currently no FDA approved products for COVID-19 prevention or treatment. There are, however, EPA approved surface disinfectants that utilize hypochlorous acid.
The FDA requires that any product containing hypochlorous acid used by patients in health-care is registered as a medical device which may be marketed by the filing company as either a prescription (Rx) or OTC product following its intended use label guidelines. However, it is the EPA that regulates disinfectants on surfaces and requires formal testing of such products to make any disinfectant claims, even if the ingredients are the same as the FDA-registered product.
Paramita Sarkar, Ph.D. and Vice President of Scientific Affairs at OCuSOFT Inc. states: “It should be noted that several hypochlorous acid products have received EPA approval for use on hard-surface disinfection. Such products contain a high concentration of hypochlorous acid and require longer contact times to achieve sufficient kill of the SARS-CoV-2 or the COVID-19 coronavirus. This would be in comparison to FDA approved hypochlorous acid-based skin-cleansing products. Thus, the public should be cautioned against assuming same efficacy and use requirements of FDA cleared or approved skin cleansing/wound care products and those of EPA approved hard surface disinfectants. OCuSOFT®’s FDA cleared HypoChlor® solution continues to provide trusted care for patients in cleansing of the skin surface around the delicate eye area.”
OCuSOFT Inc., is pleased its HypoChlor® solution has become a market leader with the OCuSOFT® Clean-N-Spray™ combo pack which includes OCuSOFT® Lid Scrub® utilizing a surfactant for oil and debris removal. Troy Smith, Senior Vice President Sales & Marketing clarifies: “At OCuSOFT®, we are careful to follow appropriate agency guidelines. We want to make sure our doctors and advisors can look to us for careful, thoughtful answers to questions regarding products and their intended, approved uses.”
About OCuSOFT Inc.
OCuSOFT Inc. is a privately-held Richmond, TX USA-based eye and skin care company with an established reputation for innovation, particularly in Ocular Surface Disease (OSD). Since 1986, OCuSOFT® has served the ophthalmic industry with a unique selection of proprietary brands and has recently been rapidly expanding its presence in the skin care market. OCuSOFT®, most recognized for its #1 Doctor Recommended Brand of Eyelid Cleansers, OCuSOFT® Lid Scrub®, is dedicated to improving each patient’s health by providing the highest quality products. For more information, please call 800-233-5469 or visit www.ocusoft.com.
Contact: Troy Smith, Senior Vice President Sales & Marketing