COVID-19 Update from the FDA: The FDA Warns Against the Use of 9 Hand Sanitizers Potentially Containing a Toxic Chemical
On June 22, 2020, the Food and Drug Administration (FDA) announced that consumers should avoid using 9 hand sanitizers that may contain a potentially fatal ingredient–methanol (wood alcohol). Exposure to methanol could be toxic if absorbed through the skin or ingested.
Which Hand Sanitizers are Listed in the Warning?
The FDA identified the following products manufactured by Eskbiochem in the warning:
- All-Clean Hand Sanitizer (NDC: 74589-002-01)
- Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
- CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
- Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
- The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
- CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
- Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)
What is the Evidence?
The FDA tested samples of Lavar Gel and CleanCare No Germ for menthanol. Lavar Gel contains 81% methanol and no ethyl alcohol, and CleanCare No Germ contains 28% methanol.
Who Manufactures These Hand Sanitizers?
On June 17, 2020, the FDA contacted the Mexican manufacturing company of the hand sanitizers, Eskbiochem, to recommend that the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. However, currently, the company has not taken action to remove these products from the markets.
What is Methanol?
Methanol is commonly known as wood alcohol. The FDA says that it “is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.”
Methanol was once manufactured by the distillation of wood. Wood alcohol was a danger for drinkers during Prohibition. In New York in 1926, about 750 people died after drinking bootleg liquor that contained wood alcohol.
What Should I Do If I Have Been Exposed to Methanol in Hand Sanitizers?
Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment which is vital for the potential reversal of toxic effects of methanol positioning.
Substantial methanol exposure may lead to:
- Blurred vision
- Permanent blindness
- Permanent damage to the nervous system
The FDA recommends that consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush these products or pour them down the drain.
Who Is Most at Risk for Methanol Poisoning?
All persons who use the listed hand sanitizers on their skin or have ingested the products are at risk. However, young children who may ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
What is the FDA Saying About Other Hand Sanitizer Manufacturers?
The FDA also expressed their concerns about other hand sanitizer companies inaccurately promoting their products as providing protection against viruses- such as COVID-19- because “there is no evidence to support these claims.”
The FDA warned the maker of Purell hand sanitizer to stop marketing their hand sanitizers as reducing or preventing diseases, citing a lack of “adequate and well-controlled studies” to support the marketing claims.
The COVID-19 pandemic caused a surge in hand sanitizer sales. In March 2020, the FDA attempted to boost the production of hand sanitizers.
In April 2020, the FDA said that it will be seeking additional information about the effectiveness and safety of three active ingredients found in over-the-counter hand sanitizers: benzalkonium chloride, ethyl alcohol, and isopropyl alcohol.
After research, the FDA concluded that 28 other active ingredients cannot be used in those antiseptic rubs anymore.
A few companies have been sued over inaccurate marketing claims, including Germ-X manufacturer Vi-Jon Inc. and hand sanitizer company BioDefense Inc.
In May 2020, a California federal judge sided with the U.S. Department of Justice (DOJ) in halting BioDefense from marketing their products as protecting against a range of infectious diseases.
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