Gojo Industries, Inc., the makers of Purell hand sanitizer, face a new class action lawsuit accusing the company of making false claims about the ability of its product to prevent disease and reduce the risk of illness. The lawsuit seeks class action status to pursue damages on behalf of consumers who were allegedly misled by claims the company made suggesting that Purell hand sanitizer can protect users from illnesses like norovirus and the flu, claims that have not been established. The class action lawsuit was filed on January 31 in the U.S. District Court for the Central District of California Western Division, indicating that Gojo Industries engaged in deceptive business practices and made false and misleading statements about the efficacy of its hand sanitizer product.
The plaintiff in the Purell class action lawsuit, Aleisa Manal, alleges that Purell hand sanitizer was marketed and sold by Gojo Industries with claims that falsely represented the product’s ability to protect users from diseases and pathogens like norovirus, MRSA, flu, Ebola and Candida auris. Based on these false and misleading claims, the lawsuit states, consumers purchased Purell, believing the product could “prevent disease and reduce illness along with other claims that go beyond the general intended use of a topical antiseptic.” According to the Purell lawsuit, because Gojo Industries made such false and misleading statements about the efficacy of its product, consumers used on the hand sanitizer to prevent illness rather than employing the appropriate preventive measures, and were thereby exposed to a greater risk of illness. The Purell lawsuit also claims that “These misrepresentations allow Defendant to increase its sales and capture market shares from its competitors.”
In order for manufacturers to legally claim that their products provide a medical benefit, such as preventing illness, the products must be reviewed under the FDA’s Premarket Approval Application process to determine their safety and effectiveness. In a warning letter sent to Gojo Industries on January 17, 2020, the FDA indicates that the company failed to follow this protocol with regard to Purell hand sanitizer. According to the letter, Purell Healthcare Advanced Hand Sanitizers are considered “new drugs” because “they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.” And new drugs cannot be introduced to the market without prior approval from the FDA, which the company failed to obtain.
Furthermore, the FDA letter warns that statements made on the company’s website “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.” The false claims Gojo is accused of making on the Purell website include the following:
According to the U.S. Centers for Disease Control and Prevention (CDC), “Washing hands with soap and water is the best way to get rid of germs in most situations.” Hand sanitizers like Purell are only meant to be used when soap and water are not readily available, yet these products are being used more and more at home and in the workplace as the first line of defense against germs, in place of soap and water. In its warning letter to Gojo Industries, the FDA gave the company 15 days to respond to the agency and indicate in writing the specific steps it has taken to correct the multitude of violations laid out by the FDA with regard to its hand sanitizer products, noting that “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.”