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Maker of Purell Draws FDA Warning and Lawsuit for Hand Sanitizer Disease Prevention Claims

GOJO Industries, the maker of Purell hand sanitizer, needs to clean up its advertising act according to the U.S. Food and Drug Administration (FDA). The FDA sent GOJO a letter on January 17, 2020 warning the company to stop making unsubstantiated claims about its hand sanitizers to avoid giving consumers the impression that they are pharmaceutical products. The FDA further stated that “the defendant’s statements regarding the efficacy of the Products to combat Ebola, norovirus, influenza, absenteeism, and common colds indicate the Products were being marketed as drugs without FDA approval.” The agency cautions that failure to promptly correct the violations may result in legal action, including seizure and injunction.

On the heels of the FDA warning letter, a class action against GOJO was filed in New York Federal court over claims that Purell products could prevent the spread of everything from the flu to Ebola. While the world braces for a possible pandemic of the Wuhan Coronavirus, GOJO assured consumers that Purell products could stem the spread of viral diseases with marketing and packaging statements such as “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE.” GOJO also stated that their products were “proven to reduce absenteeism” among students and teachers and that 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%.”

The plaintiffs charge that Purell’s marketing statements were misleading and unfair because they gave “the impression to consumers the products are effective at preventing colds, flu, absenteeism and promoting bodily health and increased academic achievement.” FDA and plaintiffs assert that GOJO could not substantiate its health claims since “no topical antiseptic products have ever been able to achieve the results defendant advertises.” Plaintiffs assert that consumers relied on GOJO’s health claims when deciding to buy products to help protect their health.

Companies that either expressly state or imply that over-the-counter products can “reduce the risk of spread” of any disease or condition are likely to attract both regulatory scrutiny and the attention of class action attorneys. The lawsuit and FDA warning letter to GOJO serve as reminders that businesses should carefully craft advertising claims and back them up with competent and reliable scientific evidence.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 41


About this Author

Sheila Millar, Keller Heckman, advertising lawyer, privacy attorney

Sheila A. Millar counsels corporate and association clients on advertising, privacy, product safety, and other public policy and regulatory compliance issues.

Ms. Millar advises clients on an array of advertising and marketing issues.  She represents clients in legislative, rulemaking and self-regulatory actions, advises on claims, and assists in developing and evaluating substantiation for claims. She also has extensive experience in privacy, data security and cybersecurity matters.  She helps clients develop website and app privacy policies,...