The US Food and Drug Administration has placed all alcohol-based hand sanitizers coming from Mexico on a nationwide "import alert" until the agency is able to review the products’ safety.
"Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination," the FDA said in a news release on Tuesday.
According to the FDA, methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and can be life-threatening if ingested. This substance is not an acceptable ingredient in hand sanitizer or other any drugs in the United States.
"Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated," said Judy McMeekin, FDA Associate Commissioner for Regulatory Affairs.
From April through December 2020, the FDA found that 84% of the samples that were analyzed were not in compliance with the FDA’s regulations.
More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels.
This is the first time the FDA has implemented a countrywide import alert for any drug product. Under this import alert, alcohol-based hand sanitizers from Mexico will be subject to heightened scrutiny, and the FDA may detain the shipments.