Story at a glance
- The hand sanitizer giant Purell was accused by the FDA of making unfounded claims that its products prevent and help stop virus spread.
- While it is considered “generally safe,” Purell’s key ingredient, alcohol, is not proven to treat more serious viruses.
- The FDC underscored problematic claims and is giving the company 15 days to respond upon the letter’s arrival.
Between the cyclical flu season and the abnormal onset of the Wuhan coronavirus, consumers everywhere are flocking to products that are designed and marketed to prevent diseases. As the virus spreads, protective face masks are selling out in China and in U.S. airports and are becoming the frontlines of battle against the disease.
As panic spreads faster than the virus, the U.S. Food and Drug Administration (FDA) recently issued a warning letter to hand sanitizer manufacturer Purell telling the company to amend uncorroborated statements about the ability of new hand sanitizer products to reduce transmission of diseases like Ebola, norovirus and influenza.
In the letter, the agency cites the Purell website acknowledging that the FDA “does not allow hand sanitizer brands to make viral claims.” Still, the website says that the main ingredient in sanitizer products — alcohol — is effective at killing or inactivating enveloped viruses, like Ebola and the flu.
The FDA argues that Purell’s statements “clearly indicate your [the company’s] suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza. As such, the statements are evidence of your products’ intended uses.”
The FDA said that no Purell products, such as Purell’s Healthcare Advanced Hand Sanitizer Gentle & Free Foam, the Healthcare Advanced Hand Sanitizer Gel, the Healthcare Advanced Hand Sanitizer Foam, the Healthcare Advanced Hand Sanitizer Gentle & Free Foam ES6 Starter Kit and the Purell Healthcare Advanced Hand Sanitizer Ultra Nourishing foam, have been tested against Ebola and the flu.
So while most Purell products can be marketed and labeled as “safe and effective” under the Generally Recognized as Safe (GRAS) category, the company cannot claim they are effective at preventing certain diseases. Purell can be marketed as consumer and health care antiseptics, but not as preventative against viruses.
In response to the FDA note, Purell’s parent company, GOJO, said that “The letter was not related to the safety and efficacy of our products, our manufacturing processes, or product quality,” and that it was primarily “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.”
The letter quoted multiple statements made on Purell’s Facebook page and Twitter. If the company does not comply with the FDA’s request and augment the selected statements, Purell and its parent company, GOJO Industries, could face legal action.
A note to anxious travelers: Dousing oneself in Purell may not keep one from contracting the Wuhan virus.