Class Action Lawsuit Says ‘No Credible Scientific Studies’ Back Purell Hand Sanitizer's Disease-Fighting Claims [UPDATE]

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Purell Advanced Hand Sanitizer is at the center of a proposed class action lawsuit that alleges claims on the product’s label with regard to its effectiveness in fighting certain diseases are backed by “no credible scientific studies.” The 15-page case comes nearly three weeks after the FDA issued a warning letter to Purell maker Gojo Industries, Inc. over what the agency described as “deficiencies” with the company’s marketing and labeling of the product. 

Highlighted in the complaint are a number of statements used on Purell's labels and the defendant’s website that the FDA warned “clearly indicate” that the product is “intended for reducing or preventing disease.” Warning the defendant that the agency is currently unaware of any adequate, well-controlled studies that show hand sanitizer’s effectiveness in preventing a multitude of diseases, the FDA reportedly informed Gojo Industries that Purell, as currently formulated and labeled, is marketed as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act.

Specifically, the lawsuit argues Gojo’s claims as to Purell’s effectiveness in killing “99.99%” of most common germs and combating Ebola, the flu, the common cold, norovirus, MRSA and VRE, and Candida Auris are backed by no credible scientific studies that link killing skin bacteria to preventing such conditions. Additionally, the case alleges the defendant has made “unqualified claims” with regard to Purell’s effectiveness against student “absenteeism.” Though Gojo claims Purell is useful in keeping children in school by preventing the spread of germs, the lawsuit argues parents are consequently given the message that their children’s use of the product will be able to reduce the number of missed school days.

More broadly, the complaint asserts that the efficacy claims associated with Purell are more likely to lead consumers away from more proven disease- and illness-fighting precautions. As the lawsuit tells it, a consumer who believes the defendant’s efficacy claims is “less likely to engage in other precautionary and preventive behavior” that may actually help avert the transmission of disease. 

Further still, the FDA, according to the suit, “has never established” that Purell’s main ingredient, ethyl alcohol, is generally recognized as safe and effective for antiseptic uses. “The Products’ claims are beyond those permitted for topical antiseptics which the FDA has allowed,” the lawsuit says, charging that no topical antiseptic products “have ever been able to achieve the results” advertised by Gojo Industries given the limitations of ethyl alcohol as a sanitizer. 

The case rounds out by noting that with the recent coronavirus outbreak, Purell has seen increased demand among consumers. According to the lawsuit, Gojo Industries’ “false, deceptive, and misleading” marketing for Purell has bolstered the company’s bottom line at the expense of those who may not have bought the product, or would have paid less for the hand sanitizer, had they known of the apparent lack of scientific evidence supporting the defendant’s claims.

“Defendant’s marketing and advertising gives the impression to consumers the Products are effective at preventing colds, flu, absenteeism and promoting bodily health and increased academic achievement,” the suit reads. “However, when consumers use the Products as intended, they are lulled into a false sense of security as to other scientifically proven measures they should take to achieve the outcomes promoted by defendant.”

The case looks to cover consumers across the country who bought Purell’s Advanced Hand Sanitizer.

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