WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has issued a warning letter against GOJO Industries Inc. concerning the marketing of its hand sanitizer brand Purell for claims that they can prevent disease from viruses like Ebola, norovirus, and influenza.
The agency notified the violations and urged the company to take prompt action to correct them. Responding to the letter, GOJO said it took immediate action, but emphasized that the FDA letter was not related to the safety or quality of its products, or its manufacturing processes.
Purell Healthcare Advanced Hand Sanitizer product line, including the over-the-counter drug products, is marketed for use in athletic facilities, schools, and offices.
In the warning letter issued on January 17, the FDA noticed the company's claims on its websites and social media platforms that include 'PURELL Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza.'
In the Frequently Asked Questions section of its websites, the company also says,'The World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending the use of alcohol-based hand sanitizer as a preventive measure for flu prevention.'
The claims also include 'Kills more than 99.99 percent of most common germs that may cause illness in a healthcare setting, including MRSA & VRE'; and that products would reduce student and teacher absenteeism in schools.
The FDA said it is 'currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.'
The FDA noted that these sanitizers are unapproved new drugs and introduction or delivery for introduction of such products into interstate commerce is prohibited.
The agency added that the PURELL Sanitizer products are not covered under any OTC monograph or ongoing rulemaking. Moreover, no product intended to prevent disease or infection from specific pathogens is being considered under FDA's OTC Drug Review.
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