According to the agency’s review of alcohol-based hand sanitizers imported from Mexico between April and December 2020, 84% of samples analyzed during that period did not comply with federal regulations. More than half of the samples contained toxic ingredients – including methanol and 1-propanol – at dangerous levels, the agency reported on Tuesday.
The active ingredient that kills germs in legitimate disinfectants is ethyl alcohol, which is edible. But some Mexican companies have replaced it with toxic methanol or wood alcohol, which is used in antifreeze.
The emergence of methanol and 1-propanol is of particular concern to experts, who have seen an influx of hand sanitizers from Mexico that have tested positive for methanol contamination although the chemical does not. not appear on the product label.
“Consumer use of hand sanitizers has increased dramatically during the coronavirus pandemic, especially when soap and water are not available, and the availability of low-quality products containing dangerous and unacceptable ingredients is not available. will not be tolerated, ”Judy McMeekin, associate commissioner of FDA Affairs regulations, said in a statement.
“Today’s actions are needed to protect the safe supply of alcohol-based hand sanitizers,” she added. “We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of American consumers in mind.”
New Import Alert means shipments of hand sanitizer from Mexico undergo a thorough review and FDA officials can detain shipments to ensure the supplier meets the requirements of the practices American-made. Tuesday’s announcement marks the first time the FDA has issued a nationwide import alert on a category of pharmaceuticals.
Exposure to methanol can create a wide range of symptoms in the patient, which range from nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma or even death.
The FDA warns that while the use of methanol as a hand sanitizer is dangerous enough, those who are most at risk for side effects are “young children who ingest these products and adolescents and adults who drink these products as. alcohol substitute ”.
The FDA first issued a consumer warning on products last June and has since issued 14 warning letters to people or companies distributing hand sanitizer with inappropriate and undeclared chemical content.
Federal agencies advise consumers who wish to purchase hand sanitizers to choose products that contain mostly alcohol, and nothing else.
The United States Centers for Disease Control and Prevention says hand sanitizers should contain at least 60% ethyl alcohol or 70% isopropyl alcohol. Other approved ingredients may include sterile distilled water, hydrogen peroxide, and glycerin, according to the United States Food and Drug Administration.
The FDA is also warning people to be careful with hand sanitizers packaged in food and drink containers, as their accidental ingestion could be dangerous.
The Associated Press contributed to this report.