ASSOCIATIONINSIGHT
Portable Sanitation Association International News
BIWEEKLY EDITION AUGUST 5, 2020
Page 24
FDA Reiterates Warning About Dangerous Alcohol-Based
Hand Sanitizers Containing Methanol, Takes Additional
Action to Address Concerning Products
Portable sanitation companies are advised to take care in selecting their vendors for alcohol-based hand sanitizer
and to check their current inventory for dangerous products that may have been purchased previously.
In a July 27, 2020 communication, the U.S. Food
and Drug Administration (FDA) continues to warn
consumers and health care professionals not to use
certain alcohol-based hand sanitizers due to the
dangerous presence of methanol, or wood alcohol—a
substance often used to create fuel and antifreeze that
can be toxic when absorbed through the skin as well as
life-threatening when ingested.
The agency has taken additional action to help
prevent certain hand sanitizers from entering the
United States by placing them on an import alert.
The FDA is proactively working with manufacturers to
recall products and is encouraging retailers to remove
products from store shelves and online marketplaces.
As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution
of products labeled as manufactured at its facilities with undeclared methanol, misleading claims—including
incorrectly stating that FDA approved these products—and improper manufacturing practices.
The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online
in June. The agency issued a further warning in early July about an increasing number of adverse events, including
blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported
to poison control centers and state departments of health. The agency continues to see these figures rise.
"Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not
readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant
about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using
all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M.
Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers
containing methanol. Producing, importing and distributing
toxic hand sanitizers poses a serious threat to the public
and will not be tolerated. The FDA will take additional
action as necessary and will continue to provide the latest
information on this issue for the health and safety of
consumers."
The agency has posted a do-not-use list of dangerous
hand sanitizer products, which is being updated regularly.
In most cases, methanol does not appear on the product
label. However, methanol is not an acceptable ingredient
in any drug, including hand sanitizer, even if methanol is
listed as an ingredient on the product label. The FDA's ongoing testing has found methanol contamination in hand
sanitizer products ranging from 1 to 80 percent.
Continued on page 25
