In a warning letter, the US Food and Drug Administration said GoJo, which makes Purell products, should stop making claims that Purell is effective at preventing diseases.
In the letter, sent Jan. 17, the FDA said GoJo posted several claims across different Purell website pages that suggested hand sanitizers could reduce the risk of illnesses like the norovirus, influenza, antibiotic-resistant staph (MRSA), Candida auris and even Ebola.
"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," FDA Director of Compliance Nicholas Lyons said in his statement.
The FDA does not say that Purell and other hand sanitizers cannot prevent disease, but that the claims have not been verified. According to FDA rules, only federally approved drugs can claim they protect people from getting sick.
The Centers for Disease Control and Prevention said hand sanitizers with at least 60 percent alcohol can prevent the spread of germs, but added that sanitizers don't get rid of all germs and may not be effective on dirty hands.
In the letter, the FDA said if GoJo wants to go through the process of getting Purell approved as a drug, then the company can market any disease-fighting claims it can prove through a peer-reviewed scientific study.
FDA ended the letter by saying, "Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction."
GoJo responded to the FDA's letter with a statement on its website, posted Jan. 24:
Late last week, GOJO received a communication in the form of a standard warning letter from the FDA. The letter was not related to the safety and efficacy of our products, our manufacturing processes, or product quality. The letter was related to some of our marketing around PURELL Hand Sanitizer on GOJO.com and through social media. GOJO will be responding to the FDA and we are taking actions to meet the FDA claim requirements. These actions will include updates to GOJO.com and other digital content. There is no impact to the products we sell.
Our intention has always been and continues to be to adhere to the FDA guidance while advancing and sharing the latest hygiene science to help improve public health.
FDA warns Purell to stop making unverified health claims about Ebola, influenza