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The Food and Drug Administration has warned the maker of Purell hand sanitizers to stop claiming its products can prevent people from catching the flu, Ebola virus, the MRSA superbug and norovirus. In a notice dated Jan. 17, the F.D.A. told Purell’s maker, Gojo Industries, that its unsubstantiated claims that Purell could reduce the potential for infection or prevent illnesses violated the Federal Food, Drug and Cosmetic Act. The agency said it was reclassifying Purell as an unapproved drug, rather than an over-the-counter product. (Kaplan, 1/28)

The letter came as the United States is bracing for one of its worst flu seasons in decades and worldwide concerns grow amid a coronavirus outbreak that has killed at least 100 people in China, where the outbreak originated. The warning targets the ways Gojo Industries, Purell’s parent company, marketed its popular line of alcohol-based gels, foams and sprays in social media materials, blog posts and frequently asked questions on the product and corporate website. Some of the statements that drew the FDA’s ire outlined in the warning appear to have been removed from Gojo and Purell sites since the FDA sent its letter on Jan. 17. (Bellware, 1/28)

“These statements, made in the context of the Frequently Asked Questions section, clearly indicates 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. 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 government letter says in part. (McDonnell and Mackinnon, 1/29)

Gojo took immediate action to rectify the situation after getting the FDA warning, the company said in a statement on its website. "It is important to emphasize that the FDA letter was not related to the safety or quality of our products, or our manufacturing processes. Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs," a Gojo spokesperson wrote to CBS MoneyWatch. (Gibson, 1/28)

Because Purell Advanced Hand Sanitizers have unempirical claims and active drug ingredients, including ethyl alcohol, the FDA labels the formula “unapproved new drugs” in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. (Elder, 1/28)