January 30, 2020
The manufacturer of Purell hand sanitizer has been warned to stop making unsubstantiated marketing claims that its topical antiseptic products protect against Ebola, MRSA, norovirus and other illnesses.
The U.S. Food & Drug Administration has informed GOJO Industries Inc. the its marketing of its Purell Healthcare Advanced Hand Sanitizer line gives a false impression that the products are pharmaceutical drugs.
The products, which include foam and gel hand sanitizers, often are marketed for use in athletic facilities, schools and offices.
In a letter sent on Jan. 17, the FDA took issues with claims that Purell "kills more than 99.9% of most common germs that may cause illness in a healthcare setting, including MRSA & VRE" and "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."
The FDA is unaware 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 letter stated.
Calling the product line "unapproved drugs," the FDA said GOJO Industries either can cease making such claims or file for new drug approval.
Samantha Williams, GOJO's corporate communications senior director, said in a statement that GOJO has taken immediate action to comply with the FDA guidelines by updating its marketing on its websites and social media content.
"It is important to emphasize that the FDA letter was not related to the safety or quality of our products, or our manufacturing processes," Williams said. "Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs."
GOJO's intention "has always been and continued to be to adhere to FDA guidance while advancing and sharing the latest hygiene science to help improve public health," Williams said.
The U.S. Centers for Disease Control and Prevention recommends alcohol-based hand sanitizers for flu prevention when soap and water is not available. However, it says the best way to prevent the spread of germs is to wash your hands with soap and water.
According to the CDC, "soap and water are more effective than hand sanitizers at removing certain kinds of germs like Cryptosporidium, norovirus and Clostridium difficile."
Hand sanitizers also lose some of their effectiveness when hands are really dirty or the correct amount is not applied.