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January 30, 2020

FDA: Stop saying Purell can prevent Ebola. (And the flu. And MRSA.)

Daily Briefing

    FDA recently warned Gojo Industries, the manufacturer of Purell products, to stop making unproven claims that its popular, over-the-counter hand sanitizers can prevent the spread of diseases such as Ebola, flu, MRSA, and norovirus in health care settings.

    Cheat sheets: Evidence-based medicine 101

    The warning comes as the United States grapples with one of the worst flu seasons it's seen in decades, and amid growing concerns over a new coronavirus outbreak, the Washington Post reports.

    FDA warns Purell maker to stop making unsubstantiated claims

    FDA in a warning letter sent Jan. 17 to Gojo claims the company made unsubstantiated claims about its popular Purell hand sanitizers—which include alcohol-based gels, foams, and sprays—in marketing posted on social media and corporate websites.

    According to FDA, Gojo claimed that Purell "[k]ills more than 99.99% of most common germs that may cause illness in a health care setting, including MRSA & VRE," and that "Purell Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug-resistant clinical strain of Candida auris in lab testing." Further, FDA said a "Frequently Asked Question" section on gojo.com stated, "Purell Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza."

    But FDA said it is unaware of any well-controlled studies supporting Gojo's claims that Purell products reduce the potential for infection or prevent illnesses. In addition, FDA said it is unaware of any clinical trials that have tested whether any hand sanitizer, including Purell products, are effective at killing the Ebola virus.

    FDA said Gojo's unproven claims positioned its line of over-the-counter hand sanitizers as pharmaceutical drugs because the claims insinuated that the products "are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease," even though FDA hasn't approved the products for those purposes. FDA said the claims also violated the Federal Food, Drug and Cosmetic Act because the agency doesn't allow manufacturers of hand sanitizers to make claims about how effective the products are at killing viruses.

    Gojo's response

    Gojo told the Post that it immediately took steps to address FDA's concerns once it received the letter.

    Samantha Williams, a spokesperson for the company, said, "We have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence."

    Experts say hand sanitizers kill germs, but don't provide long-lasting protection

    While experts acknowledge hand sanitizers are effective at killing some germs, they say it's important that people understand the products offer limited protection against viruses.

    David Dowdy, an associate professor of infectious disease and epidemiology at Johns Hopkins University's Bloomberg School of Public Health, said, "These alcohol-based hand sanitizers can provide a level of protection, but just carrying it around in your purse all day and using it is not going to prevent you with coming into contact with people who might be infectious." He explained, "If you were touching a shopping cart that someone coughing or sneezing and had the flu had used and you had used hand sanitizer before you touched your nose or mouth, it probably killed the viruses on your hand. But, the alcohol evaporates very rapidly, so if five minutes later you touched a light switch in a bathroom that someone before you with the flu had touched, you wouldn't be protected" (Kaplan, New York Times, 1/28; Bellware, Washington Post, 1/28; Kavilanz, CNN Business, 1/28).

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