The FDA Warns Purell to Stop Saying It Can Prevent the Flu and Other Serious Illnesses
The federal agency sent a warning letter to the company for making misleading marketing claims about the effectiveness of their hand sanitizing products.
Purell has long been touted as the go-to hand sanitizer for people committed to personal hygiene—and it’s easy to see why. Their recognizable pocket-size bottles fit even the tightest of spaces, and their dispensers are hallway institutions. Plus, the labels clearly state that the potent liquid “kills 99.99 percent of illness-causing germs."
But recently, the sanitizer brand's parent company Gojo Industries found themselves in hot water with the US Food and Drug Administration (FDA) for going overboard when touting the effectiveness of their products.
The Deal with the FDA's Warning
In a letter sent to Gojo last weekend, the FDA's Director of Compliance cited several unsubstantiated health claims made on Purell's website and social media platforms. They called out incidents where the company suggests Purell products can protect against serious illness—including the flu, antibiotic-resistant diseases like MRSA, the highly-contagious norovirus, and Ebola, a potentially fatal illness. (Related: Flu Symptoms Everyone Should Be Aware of as Flu Season Approaches)
The FDA took particular issue with claims on Gojo's website, such as Purell "kills more than 99.9% of most common germs that may cause illness in a healthcare setting." It also called out multiple statements within the "Frequently Asked Questions" section that, according to the agency, suggest Purell is effective at reducing or preventing diseases. According to the letter, one FAQ read:
The letter noted that “the 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 produce a corresponding clinical reduction in infection or disease caused by such bacteria or virus.”
That said, the FDA did acknowledge that the Centers for Disease Control and Prevention (CDC) currently recommends using alcohol-based hand sanitizer for flu prevention (if soap and water are not readily available), and Purell is made of ethyl alcohol. But right now, the FDA does not allow hand sanitizer brands to make claims about their efficiency for any kind of disease prevention. As far as they’re concerned, hand sanitizers are unapproved drugs, according to the letter. (Related: Can a Healthy Person Die from the Flu?)
What's really troubling about Purell's unprecedented marketing claims is that they give the illusion that these products are just as good as pharmaceutical drugs, the FDA noted. It's as if they're "intended for the diagnosis, cure, mitigation, treatment, or prevention of disease,” which is highly problematic.
Moving forward, the agency expects Gojo to correct all of their violations within 15 "working days." If the company fails to do so, however, they could face legal action and potential seizure of all of their Purell products, according to the letter.
In return, Gojo has taken immediate action to rectify the situation and issued a statement on its website.
"It is important to emphasize that the FDA letter was not related to the safety or quality of our products or our manufacturing processes," a Gojo spokesperson said in the statement. "Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs."
The statement continues, saying that Gojo takes their responsibility to comply with FDA regulations and federal law "very seriously," and had already started making updates to their websites and "other digital content."
What You Need to Know About Sanitizer & Germs
Given that the U.S. is currently in the midst of flu season, along with the growing concerns about the global coronavirus outbreak, this call to action by the FDA couldn't come at a better time. (Not to mention, everyone's buying surgical masks to avoid the coronavirus...)
While hand sanitizer and other alcohol-based formulas are good at killing surface bacteria, according to the CDC, they do not fully eradicate residue from food and other filth. They're also not strong enough to combat the bacteria that is often trapped underneath the surface of that residue, the CDC notes. That's why hand sanitizer should always be your backup plan. (Related: Is Hand Sanitizer Bad for Your Skin?)
If you're really trying to avoid germs at all costs, Wash. Your. Hands. All the time. Scrubbing your hands with soap and water for at least 20 seconds is the most effective way to remove certain types of germs like parasites, norovirus, and Clostridium difficile, a bacteria that causes life-threatening diarrhea, says the CDC.
If you're still Team Hand Sanitizer only, look to this teacher's viral post of her class' stomach-churning science experiment. Alongside a series of photos, she explained that she had her students touch a slice of bread with dirty hands, one with hand-sanitizer-cleaned hands, and one with soap-and-water-cleaned hands. Four weeks later, the only slice of bread that did not develop a disgusting array of mold was the soap-and-water one.
In situations where you can't wash your hands, the CDC recommends using hand sanitizer with contains at least 60 percent alcohol, since this concentration is more effective at killing germs. Rub it on the front and back of your hands for at least 20 seconds and wait for it to dry completely before returning to your activity, per the CDC.
Bottom line? While hand sanitizer is nice to have around and helpful in a pickle, it's no magical solution to the war against germs.