The FDA is asking hand sanitizer manufacturers
to submit research backing up claims of their products’ effectiveness. Are
plain soap and water better?
Hand
sanitizer, the gloppy alcoholic gel that’s nearly everywhere, and is supposed
to keep germs from going anywhere, is getting a second look.
The U.S.
Food and Drug Administration (FDA) wants manufacturers of hand sanitizers to
submit research securing the efficacy and safety of their products.
Why? Just
to be on the safe side.
Specifically,
the FDA wants more data on the three active ingredients in 90 percent of all
hand sanitizers: ethyl alcohol (also known as ethanol), isopropyl alcohol, and
benzalkonium chloride.
The FDA
isn’t saying it wants these products off the shelves, but the agency wants
manufacturers to submit new research on the effectiveness and safety of hand
sanitizers.
Overall,
the agency wants evidence to support alcohol-based hand sanitizers are
“generally recognized as safe,” (GRAS), which is the FDA’s system of
classifying substances as safe to use for their intended purposes.
Hand sanitizers now everywhere
One major
concern is how ubiquitous hand sanitizers have become.
From the
restroom to the airport to the grocery store, hand sanitizers have boomed since
entering the market around 2009.
“Now,
consumers are using these antiseptic rubs more often at home, work, and other
places where risk of infection is low,” Dr. Janet Woodcock, director of the
FDA’s Center for Drug Evaluation and Research, said in a press announcement.
“These
products provide a convenient alternative when hand washing with plain soap and
water is unavailable, but it’s our responsibility to determine whether these
products are safe and effective so that consumers can be confident when using
them on themselves and their families multiple times a day,” she said. “To do
that, we must fill the gaps in scientific data on certain active ingredients.”
The
active ingredient in these sanitizers is typically ethyl alcohol, the same
found in distilled spirits. At 60 to 65 percent alcohol, these hand sanitizers
are essentially 120-proof moonshine for your hands.
Since
many people use hand sanitizers multiple times a day, the FDA wants data on
long-term use, particularly in pregnant women and children.
The FDA
says emerging science suggests that for some active ingredients, systemic
exposure — what is detectible in blood or urine — is higher than previously
thought.
All told,
the FDA wants more information into how this regular and repeated exposure
impacts human health.
Many of
the hand sanitizers advertise they kill 99.99 percent of germs, another claim
the FDA would like to see more evidence to support.
While
killing germs can serve an important purpose, it’s the rise of the 0.01 percent
of the leftover bacteria that have infectious disease experts looking for ways
to approach the issue of antibiotic resistance.
Hand
sanitizers aren’t expected to contribute to antibiotic resistance because they
don’t contain antibiotics.
Are hand sanitizers really necessary?
The U.S.
Centers for Disease Control and Prevention (CDC) recommends using regular plain
soap and warm water.
Hand
sanitizers, the agency says, should be used when these methods aren’t
available.
While
hand sanitizers and antibiotic soaps have their place, using them as frequently
as we currently do may not be the best long-term solution for keeping people
safe from disease causing germs.
The CDC is
quick to point out all the times hand sanitizers shouldn’t be used. This
includes when hands are especially dirty or greasy, as bacteria can cling in
the nooks and crannies.
Hand
sanitizers, the CDC says, don’t remove harmful chemicals, such as pesticides or
heavy metals.
Other
research, however, suggests that alcohol-based hand sanitizers are ineffective
at protecting people’s hands from norovirus, the most common cause of the
stomach flu.
There is
evidence, however, that hand sanitizers can help prevent the spread of germs
from the hands of people in the same household. Other studies show it can help
prevent travelers’ diarrhea during international travel.
Overall,
a large-scale review of all available evidence suggests hand washing with plain
soap and water continues to be the best in preventing common illnesses spread
by bacteria and viruses found on common surfaces.
Under its
new request, the FDA recently issued a proposed rule for the data, which is
open to public comment for six months.
After that,
sanitizer manufacturers have a year to submit new data and information before
the FDA makes its final ruling.
In 2013
and 2015, the FDA made rulings on the use of similar over-the-counter
antiseptics, including consumer antiseptic washes and healthcare antiseptics.
Brian
Krans
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