FDA Warns Purell Manufacturer to Stop Making Unproven Marketing Claims

“GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.”

0
149
FDA Warns Purell Manufacturer to Stop Making Unproven Marketing Claims

The U.S. Food and Drug Administration (FDA) issued a warning letter to GOJO Industries, a company that manufactures Purell.

In the letter issued on January 17, the FDA has warned the company to stop making false marketing claims that Purell reduces school absenteeism and prevents infections from germs, such as norovirus, Ebola, and other drug-resistant infections.

The FDA explained that GOJO’s unproven claims violated federal regulations. The agency now considers Purell hand sanitizer an unapproved drug.

The drug regulatory body also noted that it is “unaware of any adequate and well-controlled clinical trials in the published literature that support GOJO’s claims.”

The FDA also criticized false claims that were appeared on GOJO’s official websites, including blogs, social media pages, and FAQs.

The company claims that Purell hand sanitizer “kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA [methicillin-resistant Staphylococcus aureus] & VRE [vancomycin-resistant enterococci]”

GOJO also claims, “Purell can reduce student absenteeism by up to 51%… Additionally, teachers who follow this program also experience a 10% reduction of absenteeism.”

In addition, the company claims, “Purell may be effective against viruses such as the Ebola virus, norovirus, and influenza.”

On an “FAQ” page, the company says, “The World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC) are recommending the use of alcohol-based hand sanitizer as a preventive measure for flu prevention.”

However, it is important to note that the WHO and CDC encourage using hand sanitizers to prevent the spread of flu. The CDC recommends using hand sanitizers “if soap and water are not available.”

Senior Director of Corporate Communications of GOJO Samantha Williams said, “GOJO took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency on January 17.”

“The letter was related to some of our marketing around Purell Hand Sanitizer on GOJO.com and through our social media platforms,” she added.

“It is important to emphasize that the FDA letter was not related to the safety or quality of our products or our manufacturing processes.”