FDA gives Purell brand hand sanitizer a stern warning

The US Food and Drug Administration warned the maker of Purell products to stop making claims about its products effectiveness against certain diseases.

Federal health officials called out Purell’s parent, GoJo Industries, in a letter warning about marketing claims being made that its over-the-counter hand sanitizers can help eliminate Ebola, MRSA or the flu.

(Source: Today Show)

“We are not aware of evidence demonstrating that the Purell Healthcare Advanced Hand Sanitizer products as formulated and labeled are generally recognized by qualified experts as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling,” the FDA letter stated.

The agency cited examples of what it said were unproven claims on websites and pointed to several products, including Purell advanced hand sanitizer gentle & free foam, Purell advanced hand sanitizer gel and Purell advanced hand sanitizer gentle & free foam ES6 starter kit.

“Based on claims on your product websites, which also include links to webpages where these products may be purchased, the PURELL® Healthcare Advanced Hand Sanitizers are intended for use as consumer and healthcare antiseptics,” the letter continued, noting that the claims potentially market the sanitizing products as a pharmaceutical drug.

Examples cited included: “Kills more than 99.99% 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.”

“Purell Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, may be effective against viruses such as the Ebola virus, norovirus, and influenza,” the gojo.com website stated in its “Frequently Asked Questions” section, according to the FDA.

The company will have to stop making the marketing claims or else file a new application to get Purell products to be approved for classification as a drug.

“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,” the FDA letter stated, giving the company a deadline to comply and provide “specific steps that you have taken to correct violations.”

But the company has reportedly already begun to address the issue and, according to Samantha Williams, corporate communications senior director of GoJo, they “have begun updating relevant website and other digital content as directed by the FDA.”

“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,” Williams said, according to Fox Business.

“Our intention has always been and continues to be to adhere to FDA guidance while advancing and sharing the latest hygiene science to help improve public health. Uncompromising Integrity is a core value of our Purpose-driven Family Enterprise and we apply this principle to everything we do,” Williams added.

The FDA warning and the claims of germ-killing hand sanitizers come in the wake of a coronavirus outbreak that has killed more than 100 people in China.


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