The U.S. Food and Drug Administration (FDA) announced Tuesday that it had placed all alcohol-based hand sanitizers from Mexico on a nationwide import alert to help curb the entry of unsafe products. The FDA’s press release explains that since the COVID-19 pandemic began, an influx of Mexican-made hand sanitizer products have entered the country, some of which are unsafe because they contain methanol, also known as wood alcohol. Reportedly, the nationwide import alert is the first of its kind for any category of drug product.
The import alert means that alcohol-based hand sanitizers coming from Mexico will be subject to heightened FDA scrutiny and agency staff may detain shipments. According to the agency, analyses it conducted from April through December 2020 showed that 84% of samples tested were non-compliant with FDA regulations. Allegedly, more than 50% of the tested products contained toxic additives, including dangerous levels of methanol and/or 1-propanol.
The press release explains that methanol is hazardous to health because it can cause blindness, cardiac effects, and effects on the central nervous system leading to hospitalization and death. Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs said that “[c]onsumer 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.”
McMeekin further remarked that “[t]oday’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers. 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 U.S. consumers in mind.”