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FDA warns consumers about toxic hand sanitizers

Lisa LaMotta Editor-in-Chief, Risk and Regulatory, PwC US July 16, 2020

The FDA has identified 69 hand sanitizers containing methanol, a toxin that can cause headaches, nausea, vomiting, blindness, seizures and even death. Methanol can be absorbed through the skin and is typically used as an industrial solvent or in things like antifreeze or pesticides, but can also be an unintended byproduct of alcohol distillation. The brands’ labels included on the list say they contain ethanol, or ethyl alcohol, but have tested positive for the toxic substance instead. 


The agency said in an updated warning that “all persons using these products on their hands are at risk for methanol poisoning,” but that “young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol substitute, are most at risk.”


The FDA began compiling the list in June and has updated it twice. Most of the manufacturers on the list are in Mexico.


HRI impact analysis:


The sales of toxic hand sanitizers is another byproduct of the market’s rapid pivot to meet an explosion in demand for certain medical products needed in a pandemic. Hand sanitizer became a hot commodity in February when COVID-19 began to spread in earnest in the US.


Government agencies recommended the product as a way to prevent the spread of infection, and it quickly sold out in retail stores. Many distillers of alcoholic beverages began brewing their own versions, many with varying quality and effectiveness. 


The FDA and the CDC still advise that hand-washing for 20 seconds with soap and water is still the most effective means of preventing transmission of infections. The FDA advises against using hand sanitizers that contain false or misleading claims about prolonged protection or FDA approval. 


In March, the agency issued guidance for manufacturers that want to make alcohol-based hand sanitizer. The guidance is in effect only for the duration of the health emergency. The product should contain ethanol, and the alcohol manufactured as an active pharmaceutical ingredient should not be less than 94.9% ethanol by volume. 

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