A class action lawsuit filed against the manufacturer of Purell hand sanitizer, claims consumers have been misled by deceptive advertising that suggested the product prevents disease and reduces illness, which has not been established.

The Purell class action lawsuit (PDF) was filed in the U.S. District Court Central District of California Western Division on January 31, indicating the manufacturer of the widely used hand sanitizer, Gojo Industries, Inc., has made false and misleading statements, and engaged in deceptive business practices.

Plaintiff Aleisa Manal indicates Purell was advertised and sold with claims that have subjected it to mandatory testing and approval from the U.S. Food and Drug Administration (FDA), falsely representing that it could protect consumers from diseases and pathogens like Ebola, MRSA, VRE, norovirus, flue, and Candida auris. The deceptive advertising for Purell went beyond merely describing the general intended use of a topical antiseptic, but were intended to give consumers a false sense of security, according to the complaint.

For manufacturers to legally make claims that their products offer a medical benefit, such as preventing illnesses and diseases, they must go through the FDA’s Premarket Approval Application (PMA), which is a scientific and regulatory review to evaluate the safety and effectiveness of the drug. The review process is a federal requirement intended to protect consumers against potentially adverse health consequences.

The lawsuit seeks class action status to pursue damages on behalf of users, claiming Gojo’s misrepresentations placed consumers at an increased risk of illness by using the hand sanitizer products to prevent illness and infection, rather than pursuing appropriate preventative measures.

The complaint follows an FDA warning letter issued to Gojo Industries on January 17, which instructed the manufacturer to stop making claims that its products prevent a myriad diseases and illnesses, and as a result of these advertising claims the agency stated it is reclassifying Purell as an unapproved drug.

The FDA indicated some of the marketing statements for over-the-counter Purell hand sanitizer violate the Food and Drug Cosmetic Act by claiming the product can cure, treat or prevent a disease. The agency noted Purell advertisements indicate it “kills more than 99.99% of most common germs,” including the bacteria that can cause illnesses like Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE). Some statements claim Purell can lead to “100% MRSA and VRE reduction.”

Such claims are false or unproven, according to the FDA, and go far beyond what the manufacturer is allowed to claim about Purell in its advertising.

The reclassification as an unapproved drug puts Purell well under the purview of FDA enforcement. The letter calls for GOJO to fix the advertising claims and other violations promptly, and to notify the agency of how it will address the problems within 15 days of receiving the letter.

Hand sanitizers are intended to be used when soap and water are not available. However, they have become increasingly popular in home and office settings. Too often, the topical antiseptics are left on the hands and not rinsed off with water, health experts say.

The U.S. Centers for Disease Control and Prevention (CDC) recommends using hand sanitizer only when hand-washing with soap and water is not available. Washing your hands is the best way to prevent the spread of germs and onset of illness, health experts say.

Tags: Class Action Lawsuit, False Advertising, Hand Sanitizer, Purell