GOJO Industries Inc – FDA Warning Letter, Jan 17, 2020

The FDA issued a Warning Letter to GOJO Industries, Inc. regarding their PURELL® Healthcare Advanced Hand Sanitizer product line, including various gels and foams. The agency determined that these products are marketed as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. The products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective (GRASE) for their intended uses. The violations stem from claims made on the firm's websites and social media, which suggest the hand sanitizers are effective against specific pathogens like MRSA, VRE, Candida auris, Ebola, norovirus, and influenza, and can prevent the spread of infection. Additionally, claims were made regarding the reduction of student and teacher absenteeism. The FDA states these claims go beyond the general intended use of topical antiseptics outlined in relevant OTC rulemakings and the tentative final monograph (TFM). Although ethyl alcohol is a deferred ingredient in OTC antiseptic rules, these specific disease prevention and absenteeism reduction claims are not covered by any OTC monograph or ongoing rulemaking and lack supporting clinical trials. GOJO must promptly correct these violations and respond within fifteen working days, detailing corrective actions and preventative measures, or face potential legal action.