FDA issues stern warning to Purell hand sanitizer maker

The U.S. Food and Drug Administrator has issued a strict warning to Purell-maker GOJO Industries, which claims it hand sanitizers can kill pathogens that cause illness in as little as 15 seconds.

The company also claims its hand sanitizer is effective in reducing the risk of diseases, including norovirus, Ebola virus, influenza, and Methicillin-resistance Staphylococcus aureus (MRSA), a superbug resistant to almost all antibiotics.

Image Credit: Alexander Raths / Shutterstock
Image Credit: Alexander Raths / Shutterstock

Efficacy claims

The FDA sent a warning letter to the company for inappropriately marketing the hand sanitizer as an effective way to prevent a broad range of diseases. The warning comes amid the current outbreak of the Wuhan coronavirus, or the 2019-NCoV, which has killed more than 100 people in China and infected nearly 6,000 people, and the early onset of the country’s flu season.

In the letter dated Jan. 17, 2020, the FDA emphasized that the company has posted various claims in their website, saying their product is effective in killing 99.9% of germs, particularly norovirus, MRSA, and VRE.

“On your websites, your firm markets these products individually as well as in combination with other PURELL products for use in various settings, such as athletic facilities, schools, and offices, under the title of THE PURELL SOLUTION,” Nicholas F. Lyons, Director of Compliance, U. S. Food and Drug Administration, said in the letter.

The regulatory body emphasized that at present, there isn’t any hand sanitizers available that have been tested and approved against Ebola viruses.

The company also claimed that their hand sanitizer, which can be purchased over-the-counter, are effective in the prevention of disease from pathogens and the spread of infection. In the website, the company stated several claims that their product is effective in lowering the risk of illness, and even disease-related student and teacher absenteeism.

“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,” Lyons added.

Stern warning

Gojo’s marketing implies that some of its products can be used for disease prevention. The FDA said the company claims their products are drugs but are not listed and approved by the regulatory agency.

The FDA issued the stern warning, saying that the violations cited in the letter should be addressed by the company. It added that failure to correct the violations may result in legal action without further notice, giving the company 15 working days to notify the regulatory agency about steps taken to correct the violations.

Meanwhile, GOJO took immediate action upon the receipt of the FDA letter. In a corporate statement, the company stated that the letter wasn’t about its product safety and quality and it should continue to be used as a part of good hand hygiene practice to reduce pathogens or germs.

“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,” GOJO said.

“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,” it added.

Handwashing still recommended

The U.S. Centers for Disease Control and Prevention (CDC) said that handwashing is still one of the best ways to protect oneself from getting sick and contracting infectious diseases. Still, washing with soap and water is the best way to get rid of germs. You can only use alcohol-based hand sanitizers that contain at least 60 percent alcohol only when water and soap are not available.

Hand sanitizer-use is a faster means to reduce the number of germs in the hands, however, it isn’t effective in getting rid of all types of pathogens or germs, it may not be effective in removing dirt or grease from the hands, and it can’t remove harmful chemicals from the hands, including heavy metals and pesticides.

The CDC recommends people to wash their hands with soap and water before, during and after preparing food, before and after caring for a sick person, before consuming food, after using the toilet, before and after treating a wound, after touching animals or animal waste, after touching garbage, after handing pet food or treats, after coughing, sneezing, or blowing the nose, and after changing diapers or cleaning up a child who used the toilet.

Angela Betsaida B. Laguipo

Written by

Angela Betsaida B. Laguipo

Angela is a nurse by profession and a writer by heart. She graduated with honors (Cum Laude) for her Bachelor of Nursing degree at the University of Baguio, Philippines. She is currently completing her Master's Degree where she specialized in Maternal and Child Nursing and worked as a clinical instructor and educator in the School of Nursing at the University of Baguio.


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