FDA Must Step Up Oversight of Hand Sanitizer Safety

By Marlene Wüst Smith, MD

Hand sanitizer – it’s the go-to item for protecting our kids, even our “big” kids, those attending college in person.

We keep it in our cars, our briefcases, kids’ backpacks, and our purses. There is even a giant communal bottle at the entrance of every store, restaurant, and supermarket.

Now, with recent lifts in public health guidelines and our kids returning to in-person learning and participating in summer activities, it’s time we ask ourselves: is the hand sanitizer we’re giving them truly keeping them safe from exposure to germs and pathogens?

That question has become more difficult to answer. A year ago, at the onset of the pandemic, the FDA released emergency guidance that lowered standards for hand sanitizer. This led to an influx of toxic and subpar hand sanitizers to enter the market, and unfortunately, the FDA has still not rescinded this emergency guidance. Now, we are continuing to see the consequences of these products remaining on the market play out across the country.

Peer-reviewed and reputable research have shown the overwhelming benefits of using hand sanitizer in combination with proper handwashing as a part of an effective hygiene protocol. Alcohol-based sanitizer, according to a 2010 study published in the Journal of Food Protection, “can be very effective for rapidly destroying some pathogens by the action of the aqueous alcohol solution without the need for water or drying with towels.”

However, not all hand sanitizers are equally effective. The key takeaway from the public health research: your hand sanitizer should contain at least 60 percent alcohol. If you are buying a low-alcohol or alcohol-free hand sanitizer, you are gambling with your protection.

Recently, the FDA released a warning on the side effects of inhaling vapors of alcohol-based hand sanitizers. In that same warning, it showed that the uptick in adverse effects to alcohol-based hand sanitizers happened after March 2020, when the emergency guidance relaxed standards for production. Clearly, there is a correlation between these faulty hand sanitizers and adverse effects, yet the FDA has still not rescinded this emergency guidance.

Another important factor: doing your research and buying from manufacturers with a track record of consistently producing high-quality and effective hand sanitizer products. The FDA has also issued frightening warnings and product recalls for hundreds of unsafe hand sanitizer products. One study found that a sanitizer with more than 10,000 Amazon reviews contained high levels of benzene, a chemical that the World Health Organization says can cause cancer. Some of these popular hand sanitizers had benzene levels eight times higher than the FDA’s limit.

As a pediatrician who works as the sole physician at a small private university, our team was tasked by our university president to do “whatever it would take” to get our students through two on-campus/in-person semesters after abruptly closing during the height of the COVID-19 pandemic in Spring 2020. This included finding new sources for purchasing enough PPE, hand sanitizer, and cleaning solutions, as our usual suppliers were unable to fulfill orders.

I was appalled at the quality (or lack thereof) of some of the supplies we received. We had to throw away gallons of non-OSHA-compliant hand sanitizer that smelled like pure gasoline, packaged in plastic containers that had sloppily printed labels on them. No MSDS (Materials Safety Data Sheets) accompanied some of the sanitizers we received. The supplies that came from the New York State Department of Health smelled nice but were packaged in large bottles with pump devices that inadvertently sprayed large amounts of liquid on unsuspecting users. This all resulted in us spending thousands of dollars to safely discard unusable supplies, as the mailing costs for returning them exceeded the original purchasing costs.

We are past the unprecedented demand surge caused by COVID-19, and reopening is imminent across schools, businesses, and cities. Not only should the FDA pull back emergency guidance on hand sanitizer, but it is equally as important that it starts to enforce higher standards on the products on and entering the market.

However, until the necessary regulatory bodies take action to protect consumers, it is imperative that we take action ourselves. I recommend that parents, schools and business owners purchase and provide hand sanitizer products that contain at least 60 percent alcohol, and that you properly discard any pandemic purchases that do not meet quality standards.


  Dr. Marlene Wüst-Smith is the founder and publisher of Physician Outlook Magazine, a print and online magazine that hopes to change the division between the once sacred physician and patient relationship.