OR WAIT 15 SECS
Purell makes unsubstantiated claims about what its hand sanitizer products can do, the US Food and Drug Administration (FDA) charges. In a warning letter, dated January 17, the agency cites Purell’s claims that its products can reduce or prevent disease from the Ebola virus, norovirus, and influenza.
“As such, the statements are evidence of your products’ intended uses,” the FDA states. “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 demands that Purell “take prompt action” to correct the violations cited by the agency. “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction,” the letter states “Within fifteen working days after you receive this letter, please notify this office in writing of the specific steps that you have taken to correct violations.”
The letter, from Nicholas F. Lyons, the FDA’s director of compliance and addressed to Carey Jaros, the president and CEO of GOJO Industries, which manufactures Purell products, states that the company makes misleading claims on its website and Facebook page. The answers to questions on the “frequently asked questions” part of the webpage clearly indicate that the products are effective against as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, says the FDA.
Samantha Williams, GOJO’s senior director of corporate communications, tells Infection Control Today® that the company took “immediate action” upon receiving the FDA letter. “The letter was related to some of our marketing around Purell Hand Sanitizer on GOJO.com and through our social media platforms,” Williams said. “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 adds that “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. 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.”
Purell markets their products under the OTC Drug Review rule. However, the FDA believes that the claims the company makes about its products mean that they should be classified as new drugs “because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA.”
The FDA also challenges Purell’s claim that the hand sanitizers can reduce illness- and disease-related absenteeism for students and teachers. Those claims “go beyond merely describing the general intended use of a topical antiseptic as set forth” in the OTC Drug Review rule. Purell’s website claims to reduce student absenteeism by 51% and teacher absenteeism by 10%, the letter charges.
“Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation,” the FDA letter states. “If you believe that your products are not drugs or unapproved new drugs or otherwise may be legally marketed, please provide your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.”