The FDA, in a warning letter dated January 17, 2020 addressed to GOJO Industries, which markets Purell, addressed the FDA’s concerns regarding “marketing of the PURELL® Healthcare Advanced Hand Sanitizer product line that includes the over-the-counter (OTC) drug products “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gel,” “PURELL® Healthcare Advanced Hand Sanitizer Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam ES6 Starter Kit,” and “PURELL® Healthcare Advanced Hand Sanitizer ULTRA NOURISHING Foam.”
The FDA warned: “As currently formulated and labeled, PURELL® Healthcare Advanced Hand Sanitizers are 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). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).”
The FDA addressed the marketing of Purell in its warning letter: “On your PURELL® Healthcare Advanced Hand Sanitizer product pages: “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”” … “On your webpage titled, “The PURELL SOLUTION™ for Athletic Facilities”: “PURELL® Products Help Eliminate MRSA & VRE . . . 100% MRSA & VRE Reduction . . . A recent outcome study shows that providing the right products, in a customized solution, along with educational resources for athletes and staff can reduce MRSA and VRE by 100%”” … “On your Facebook page at https://www.facebook.com/purell/: “The PURELL SOLUTION™ has the products you need to help prevent the spread of infection this germ season. Visit GOJO.com for more information.”” … “Are PURELL® Hand Sanitizer products effective against the flu? The FDA does not allow hand sanitizer brands to make viral claims, but from a scientific perspective, influenza is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol. 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””
“In addition, you make statements within the “Frequently Asked Questions” on your website, www.gojo.com, that suggest that PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza.”
The FDA stated: “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. 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. Based on the above claims, PURELL® Healthcare Advanced Hand Sanitizers are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Further, your PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, are intended for use as both consumer antiseptic rubs and health care antiseptic rubs. Although the individual products claim to be “designed for healthcare environments,” consumers can buy these products from the websites linked to the “Where to Buy” tabs listed on your product website.”
The FDA continued: “Furthermore, PURELL® Healthcare Advanced Hand Sanitizers are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA approved applications pursuant to section 505 of the Act, 21 U.S.C. 355, are in effect for your PURELL® Healthcare Advanced Hand Sanitizers, nor are we aware of any adequate and well controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are generally recognized as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).”
The FDA stated: “Until FDA promulgates final rules establishing whether ethyl alcohol, as one of the deferred ingredients listed in the two rules above, is generally recognized as safe and effective (GRASE) for the antiseptic uses described above, the agency generally does not intend to object to the marketing of products, provided they meet the proposed formulation and labeling conditions described in the relevant tentative final monograph (TFM) and each general condition in 21 CFR 330.1 and provided that a particular product does not constitute a hazard to health. Such marketing, however, is subject to the risk that a final rule may require reformulation, relabeling, and/or FDA approval under section 505 of the FD&C Act, 21 U.S.C. 355.”
The FDA warned: “Your PURELL® Healthcare Advanced Hand Sanitizer products do not comply with the relevant TFM. Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Furthermore, the claims on your product websites suggest that PURELL® Healthcare Advanced Hand Sanitizers are effective in reducing illness or disease-related student and teacher absenteeism also go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Such claims are not described in any OTC final rule, the above-referenced TFM (see 59 FR 31402, June 17,1994), or any rulemakings being considered under the OTC Drug Review. Additionally, we are unaware of any adequate and well-controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are GRASE for the above-described intended uses. Furthermore, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.”
The FDA concluded: “we are not aware of evidence demonstrating that the PURELL® Healthcare Advanced Hand Sanitizer products as formulated and labeled are generally recognized by qualified experts as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling.”
GOJO Industries is being sued over its marketing of the effectiveness of the Purell hand sanitizer products, the most recent lawsuit having been filed in federal court in northern Ohio on March 13, 2020: GOJO Industries is alleged to have “marketed its products as a way to prevent infection, the flu and the common cold. Its products are now in high demand and scarce as Americans scooped up record amounts in response to the coronavirus. However, the company’s labeling and marketing, including that its Purell Advanced Hand Sanitizer ‘kills 99.9% of illness-causing germs,’ is misleading and constitutes false advertising.” The federal lawsuit was filed on behalf of consumers in California, Michigan, Massachusetts and Oregon, and is one of six filed across the United States against GOJO Industries.
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