A warning letter sent by the US Food and Drug Administration (FDA) has warned GoJo, the maker of Purell products, to 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.
Some of the claims on the company’s website include:
- “Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE”
- “To help prevent transmission, hand hygiene with an alcohol-based hand sanitizer is recommended along with hand washing if hands are soiled. PURELL® Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug resistant clinical strain of Candida auris in lab testing.”
- “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.”
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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.
The FDA letter ended by noting, “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.