The U.S. Food and Drug Administration (FDA) has placed all alcohol-based hand sanitizers from Mexico on a countrywide “import alert” that will allow federal agents to detain shipments until the products are determined to be safe to bring into the U.S.
The first-of-its-kind countrywide action comes after the FDA found that between April and December 2020, the vast majority (84 percent) of the samples tested from Mexico were not in compliance with agency regulations. Worse, more than half of the Mexican-produced sanitizers contained toxic methanol or 1-propanol at dangerous levels.
"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,” Judy McMeekin, FDA associate commissioner for regulatory affairs, said in a statement.
The agency first issued a consumer alert in June 2020 for nine hand sanitizers manufactured in Mexico that contained methanol, also known as wood alcohol. A Centers for Disease Control and Prevention (CDC) report found that from May 1 to June 30, 15 adults (13 men and two women with a history of swallowing alcohol-based hand sanitizers) were hospitalized after ingesting methanol-tainted products. Four died, and three were discharged from the hospital with vision impairment.
The FDA has since expanded its warning list to more than 200 hand sanitizers from 50 Mexican manufacturers as well as others made in China, Turkey, Korea, Guatemala and six U.S. states that have been found to contain methanol or 1-propanol, a chemical that if ingested can cause central nervous system depression, which can result in death, the agency warns.
The FDA has also issued 14 warning letters to businesses since July 2020 for distributing hand sanitizer with undeclared methanol and inappropriate ethanol content, for making misleading claims (including incorrectly stating FDA approval) and for engaging in improper manufacturing practices.
The agency previously issued import alerts on specific products that were found to be tainted. Under the first-of-its-kind countrywide alert for an entire category of drug products, agents can “detain without physical examination (DWPE)” any “alcohol-based hand sanitizer drug products offered for entry from the country of Mexico,” with the exception of FDA-approved manufacturers on a “Green List."