January 28, 2021
In FDA’s efforts to protect consumers from potentially dangerous or sub-potent hand sanitizers, all alcohol-based hand sanitizers from Mexico have been placed on a countrywide import alert to assist in preventing products that appear to be in violation from entering the US until FDA is able to review the product’s safety.
Over the course of the ongoing pandemic, the agency has seen a sharp increase in sanitizers from Mexico labeled to contain ethanol (also known as ethyl alcohol) which tested positive for methanol contamination. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizers or other drugs.
Under the import alert, the products from Mexico are subject to heightened FDA scrutiny and may be detained. As part of the entry process review, FDA staff will take any specific evidence from the importers or manufacturers to demonstrate the hand sanitizers were produced according to US current requirements. This marks the first time FDA has issued a countrywide import alert for any category of drug product.
FDA’s analysis of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed from April to December 2020 were not in compliance. More than 50% of samples contained toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. FDA has posted a list of hand sanitizers that consumers should not use. The list can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.
For further information regarding this import alert, please see the below link:
Crane Trade Services can assist you with questions regarding this import alert. For assistance please contact CWTSConsulting@craneww.com.