FDA Issues Stern Warning to Purell for False Claims on Hand Sanitizer

Purell hand sanitizer gel in bottle

As consumers, we rely on the integrity of a company’s claims for honest sales.  But what happens when claims are made and are not backed up?  Purell is one of those companies that are about to find out the hard way.

The USFDA gave a stern warning to the maker of Purell products to “Stop making unproven claims that over-the-counter hand sanitizers help eliminate Ebola, MRSA or the flu.”

At a time when flu season is in full force and the recent scare epidemic going around the world with coronavirus, no one on earth needs to be fed false information, and the FDA is putting a stop to fraudulent claims.

Gojo Industries, which is the parent company of Purell, received a “warning letter” concerning the marketing claims that their sanitation products are related to a pharmaceutical drug more than an over the counter product.

The FDA says their products have not been proven in the claims they are making, and they are attacking the products made on purell.com, gojo.com, and social media.  Noted by the FDA, Purell advanced hand sanitizer gel and the advanced hand sanitizer gentle & free foam ES6 starter kit are mostly sold in schools, athletic facilities, and offices.

The claim made by Purell states, “Purell ‘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.”

On the webpage of gojo.com, under the commonly known section of “Frequently Asked Questions,” the company is making a claim, “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 FDA is saying this is also an unproven statement.  They are not familiar with any hand sanitizers which were tested under the list of Purell products.

The FDA has another issue with another claim the company has made saying their products have been proven to “reduce student absenteeism by up to 51 percent.”  Companies are forbidden to make such claims for any hand sanitizers.

The Centers for Disease Control and Prevention only allows the push for people to use an alcohol-based hand sanitizer to help in preventing the spread of the flu virus.  The main ingredient in Purell hand sanitizers is ethyl alcohol.

According to the agency, Gojo Industries are marketing their products as drugs.  The reasoning behind this is “because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.”  This is how they came to a conclusion they will stop the company in their tracks.

The FDA left two options for Gojo Industries in the “warning letter.”  It stated, “It can market Purell as a drug, and file a new application to get approval for the Purell products to be classified as such. Or it can stop making those marketing claims altogether.”

So the final answer, for now, is hand sanitizers are not drug products.  Gojo Industries will have a short time to investigate and correct their statements, which are in violation of FDA codes.  The FDA will seek legal action if these demands are not met, and they have the right to seize all of Purell’s products.

Gojo Industries spokeswoman Samantha Williams put out this statement in response to the FDA’s warning.  She said, “We have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence.”

The FDA has made it clear they are not attacking the quality or safety of any of Purell products.  They are only attacking the marketing and fraudulent claims which the FDA has not approved.

Purell products are not the only ones who took a hit from the FDA.  Johnson & Johnson made past claims that their mouthwash known as Listerine was used to prevent gum disease and removes plaque.  These claims were not approved or tested by the FDA.

Many companies make claims to get more sales.  The FDA has been a thorn in many companies’ sides, but they are doing their job for the most part.  With illnesses like the recent coronavirus, consumers need the truth when it comes to making claims about products.  If a product fails on its claims, the companies can be sued by the consumers as well as the FDA.  It would be bad for everyone involved.