With cold and flu season in full swing and headlines about the deadly China coronavirus outbreak appearing everywhere these days, it's understandable why people might be reaching for their bottles of Purell hand sanitizer. However, the U.S. Food and Drug Administration has warned the maker of the popular hand sanitizers, Gojo Industries, that they need to stop claiming that some of their products can help guard people against threats like the norovirus, flu, and even the Ebola virus.
According to a warning letter sent to Gojo Industries by the FDA on January 17, the Ohio manufacturer is making unfounded claims on its website and social media about the effectiveness of its alcohol-based gels, foams and sprays.
"These statements, made in the context of the Frequently Asked Questions section, clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza. As such, the statements are evidence of your products’ intended uses," the FDA's letter stated. "However, FDA 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 letter also asks the company to stop claiming its hand sanitizers lead to reduced "student absenteeism by up to 51%" as well as cease promoting the alcohol-based sanitizers as a defense in locker rooms and other germ-laden environments.
Gojo's marketing appears to indicate that its hand sanitizers are a preventive measure to disease, which implies they are drugs, even though they are not classified as such, the FDA's letter says.
In a statement posted to its corporate website, Gojo said they had taken "immediate action" in response to the FDA's letter.
"It is important to emphasize that the FDA letter was not related to the safety or quality of our products, or our manufacturing processes," the company said in a statement. "Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs.
"It is our responsibility to ensure that we comply with all requirements of FDA regulations and federal law, and we take that responsibility very seriously," the company's statement added. "To that end, we have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence."
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