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FDA warns makers of Purell to cease advertising topical antiseptic as preventative drug
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FDA warns makers of Purell to cease advertising topical antiseptic as preventative drug

The US Food and Drug Administration (FDA) sent a warning letter to GOJO Industries, the makers of Purell hand sanitizer, to cease making claims that Purell can prevent the spread of diseases such as the flu, norovirus, and Ebola.

On its website and social media are claims that the hand sanitizer can kill “99.99% of most common germs … including MRSA & VRE,” and statements on Purell’s Frequently Asked Questions page suggest Purell is intended to prevent flu, norovirus, and Ebola. The FDA letter says “the[se] statements are evidence of your products’ intended uses,” but that the FDA is unaware of any controlled studies showing “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.”

Because none of the claims are backed by empirical studies, and because Purell contains ethyl alcohol, an active drug ingredient, the FDA has determined that Purell sanitizers fall under the category of “unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 355(a).” In the letter, dated January 17, the FDA gave GOJO 15 days to respond with the steps they plan to take to correct the violations. GOJO responded with their own statement that they would change their marketing to meet FDA standards.