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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