The federal Food and Drug Administration (FDA) warned Purell to stop claiming its hand sanitizer could kill Ebola, the flu, and other viruses. In a letter sent to GOJO Industries Inc. earlier this month, the FDA noted the company's Purell Advanced Hand Sanitizer product line was in violation of the Federal Food, Drug, and Cosmetic Act due to some of its marketing claims.
The FDA accused GOJO, the company behind Purell, of marketing its hand sanitizer products with claims that imply they can be used to kill viruses and prevent disease. According to the FDA, claims like these suggest Purell is a drug rather than an over-the-counter consumer and healthcare antiseptic.
"Statements, made in the context of [your website's] 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 wrote in its Jan. 17 letter to GOJO. "As such, the statements are evidence of your products' intended uses. However, 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."
The FDA went on to warn GOJO that its labeling claims regarding Purell's effectiveness in preventing disease or infection "go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings." Similarly, they also warned that claims regarding the products effectiveness in reducing disease-related student absenteeism also went beyond describing the products intended use as a topical antiseptic.
To continue marketing its products with these claims, GOJO would need to file a new application for approval and re-classification as a drug with the FDA, according to CNN. That, however, doesn't appear to be the direction GOJO has decided to go.
GOJO has said it took "immediate action" to respond to the FDA's claim requirements and warnings regarding some of its marketing for Purell.
"It is our responsibility to ensure that we comply with all requirements of FDA regulations and federal law, and we take that responsibility very seriously," GOJO spokesperson Samantha Williams said in a corporate statement released last week. "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."
As of Wednesday, many of the specific claims cited in the FDA's letter appeared to have been removed from the Purell website and Frequently Asked Questions section.
Williams said GOJO's intent has always been to adhere to FDA guidance while sharing the latest hygiene science with consumers. Additionally, she stressed that nothing in the FDA's letter had referred to the safety or quality of GOJO's Purell products.
"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."