CUYAHOGA FALLS, Ohio - The U.S. Food and Drug Administration sent Purell a warning letter on Monday that told the company to stop claiming that one of its hand sanitizer product lines prevents Ebola.
The letter concerned the company’s marketing of the Purell Healthcare Advanced Hand Sanitizer product line that includes the following over-the-counter (OTC) drug products: “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gel,” “PURELL® Healthcare Advanced Hand Sanitizer Foam,” “PURELL® Healthcare Advanced Hand Sanitizer Gentle & Free Foam ES6 Starter Kit” and “PURELL® Healthcare Advanced Hand Sanitizer ULTRA NOURISHING™ Foam.”
The FDA said Purell makes statements within the “Frequently Asked Questions” on the company’s website, www.gojo.com, that suggest the Purell Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus and influenza.
FILE: Purell sanitizer brand name. Logo or sign belonging to the Gojo company. (Photo by Roberto Machado Noa/LightRocket via Getty Images)
The public health agency referred to three of the company’s questions and answers regarding its health-related claims.
“What Steps Can I Take to Prevent the Spread of Norovirus?” is the first question.
“Even though norovirus is highly contagious, there are ways you can reduce the risk of its spread. According to the Centers for Disease Control and Prevention, follow these steps to reduce the spread of the virus. 1. Practice good hand hygiene. Make sure to wash your hands with soap and water at key moments, especially after using the restroom since the virus can spread through stool. Alcohol-based hand sanitizers with at least 60% alcohol can be used in addition to handwashing,” Purell answered.
“Are PURELL® Hand Sanitizer products effective against the flu?” is the second question.
“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. The World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending the use of alcohol-based hand sanitizer as a preventive measure for flu prevention,” Purell answered.
“Is PURELL® Advanced Hand Sanitizer Effective Against Ebola?” is the third question.
“As of today, we are not aware of any hand sanitizers that have been tested against Ebola viruses, including PURELL® Advanced Hand Sanitizer. However, it is important to note that the Ebola virus is an enveloped virus. Enveloped viruses in general are easily killed or inactivated by alcohol. *World Health Organization (WHO)* and the *Center for Disease Control and Prevention (CDC)* are recommending the use of alcohol-based hand sanitizer as a preventive measure during this outbreak,” the company answered.
“These statements, made in the context of the Frequently Asked Questions section, clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza,” the FDA said. “As such, the statements are evidence of your products’ intended uses.”
However, the FDA said it is currently 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.”
Purell responded in a statement on Friday.
“GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17. The letter was related to some of our marketing around PURELL® Hand Sanitizer on GOJO.com and through our social media platforms,” said Samantha Williams, who is corporate communications senior director of GOJO.
“It is important to emphasize that the FDA letter was not related to the safety or quality of our products, or our manufacturing processes. Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs,” she said.
Williams said it is the company’s responsibility to ensure that they comply with all requirements of FDA regulations and federal law, “and we take that responsibility very seriously. To that end, we have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence.”
This story was reported from Los Angeles.