Suits' independent study sheds light on dangers of contaminated hand sanitizers

January 8, 2020

Certain images have become synonymous with the coronavirus pandemic of 2020, among them long lines at retail stores, empty shelves in paper aisles, and, more recently, the sudden influx of unknown hand sanitizer products to placate the shortage experienced throughout most of the spring and summer.

The latter is of major concern to Community College of Rhode Island Organic Chemistry Professor Wayne Suits, who, after the U.S. Food and Drug Administration began recalling hand sanitizer products from the shelves in June due to potential methanol contamination, conducted his own independent experiment to determine whether or not some of the new brands on the market were as safe as advertised.

With a little nudge from his wife – a pharmacist and a CCRI Chemical Technology alumna – Suits and his Chem. Tech. students used a Perkin Elmer Gas Chromatograph, a device that tests for contaminants and quality in food, flavors and fragrances, to run samples of 15 commercial hand sanitizers, several of which the students brought to campus from their own homes.

The results, Suits said, were “eye-opening;” of the 15 brands sampled, “several,” according to Suits’ research, contained methanol, a substance that can be toxic when absorbed through the skin or life-threatening when ingested.  Symptoms range from headaches and nausea to kidney failure and death depending on the level of exposure.

Suits consolidated his class’ research into a short video and shared it with Perkin Elmer, which subsequently donated a state-of-the-art analytical instrument to the college’s Chemical Technology Program that will help expedite future hand sanitizer studies. With an autosampler that can now accommodate up to 40 samples at a time, Suits plans to open up his study to any faculty or staff member interested in analyzing the sanitizer(s) they use at home.

The risk of inadvertently purchasing a contaminated hand sanitizer doesn’t appear to be going away anytime soon; since June, the FDA’s list of sanitizers with potentially harmful side effects has grown from nine to 215, and, in November, an additional 10 products were pulled from shelves as COVID-19 cases began to surge during the holiday season.

“It’s scary,” Suits said. “There’s no amount of methanol that’s really safe. There shouldn’t be any in hand sanitizer at all.”

Suits’ findings, and the numerous recalls by the FDA, highlight two important questions: Where are these sanitizers coming from and why do they contain a potentially toxic ingredient?

According to the FDA’s recall list, an alarming number of the contaminated sanitizers were manufactured in Mexico. Suits’ study yielded similar results – the “major offenders,” as he noted, were sanitizers manufactured in Mexico, which not only contained dangerous levels of methanol, but also contained low levels of ethanol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The Centers for Disease Control and Prevention recommends using alcohol-based hand sanitizers that contains at least 60% isopropyl.

“If you want a rule of thumb to assess the value of your sanitizer,” Suits says, “look carefully at the place where it was made.”

Another issue, Suits notes, is the FDA and Environmental Protection Agency (EPA) in June began loosening their restrictions on which manufacturers were allowed to produce sanitizer products as the pandemic worsened and the shortage intensified.

The FDA, in particular, even began allowing small amounts of impurities in sanitizer products to help expedite production; for example, further revisions to the policy allowed for newly-manufactured sanitizers to contain up to 50 milligrams per liter (mg/L) of acetaldehyde, which some studies consider is carcinogenic in humans.

With a temporary policy in place, several major manufacturers – among them distilleries, liquor companies and factories producing pesticides and disinfectants – began switching gears to produce their own sanitizer to fight the shortage, whether, Suits says, to seize a financial opportunity or fulfill a moral obligation.

The problem, according to Suits, is technical-grade ethanol manufactured for industrial uses – for example, window cleaning or sterilizing medical equipment – often contains traces of methanol and other contaminants but is also 60 times cheaper than pharmaceutical-grade ethanol.  So, being allowed to use it in place of pharmaceutical-grade ethanol makes hand sanitizer production a very profitable venture.

“Furthermore, the FDA does not add any special labelling on hand sanitizer products to inform the consumer as to whether it is made from technical-grade or pharmaceutical grade ethanol. Therefore, you can read the label, but you really don’t know,” Suits said.

With a higher number of various manufacturers from a wide array of industries registering with the FDA to produce sanitizers since the start of the pandemic, the likelihood of sanitizer products made from technical-grade ethanol reaching the shelves has increased, highlighting the necessity of studies similar to what Suits and his students have worked on in the classroom. The FDA continues to recall potentially harmful products, and Suits said he and his team will do its part to report those in violation, but that’s as far as he plans on taking his study – “I cannot make it my life’s work,” he said – other than providing those within the CCRI community the opportunity to run tests on their own sanitizer.

The results of his research prove one can never be too cautious during this pandemic, even with products considered among the safest on the market.  

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