FDA Puts All Hand Sanitizers From Mexico on Import Alert

FDA is setting a countrywide import alert on all alcohol-based hand sanitizers from Mexico that will allow the agency to stop and detain shipments at the border while it reviews their safety, FDA said by email Jan. 26. Prompted by a sharp increase in hand sanitizers from Mexico that purport to contain ethanol but tested positive for methanol contamination, Import Alert 62-08 is the first one issued countrywide on any category of drug product, FDA said.

“Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment,” FDA said in a news release. “As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements.”

According to FDA, agency analyses of alcohol-based hand sanitizers from Mexico revealed that 94% of samples tested April through December 2020 were not in compliance with FDA regulations. “More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels,” FDA said. Methanol can be toxic when absorbed through the skin and life-threatening when ingested, and “is not an acceptable ingredient in hand sanitizer or other drugs,” FDA said.

The import alert does provide for a “green list” of firms exempt from detention without physical examination. Companies that wish to be added to the green list, or have individual detained shipments released, may submit evidence including records from the manufacturer regarding the active ingredient used in the subject hand sanitizers, the full formula of all its hand sanitizers subject to the import alert, records on manufacturing sites, and information from the manufacturer indicating full compliance with current good manufacturing practice requirements, FDA said.