On January 26, the U.S. Food and Drug Administration (FDA) announced about continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. 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. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs,” – the Administration said.
Alcohol-Based Hand Sanitizers Import Alert 62-08
Alcohol-based hand sanitizers are drugs regulated by the FDA and are generally considered nonprescription, over-the-counter (OTC) drug products. For the purposes of this Import Alert “alcohol-based hand sanitizers” are those purported to contain ethanol (also known as “ethyl alcohol” or “alcohol”) or isopropyl alcohol (also known as “2-propanol”) as the active ingredient.
From early April 2020 through the end of December 2020, FDA collected 112 samples of alcohol-based hand sanitizer products from 53 different Mexican manufacturers who offered the product for import into the United States. The manufacturers sampled account for 60.4% of the total lines of alcohol-based hand sanitizer products imported from Mexico during this time period. Of the 112 analyses that have been completed, 94 (84%) of the samples were found to be violative and 18 (16%) compliant.
Further, of the 94 samples found to be violative, 74 were due to the presence of methanol and/or 1-propanol at unacceptable levels and 20 were due to insufficient levels of active ingredient (alcohol subpotency). This presents serious safety concerns, as the FDA is aware of at least 20 recent deaths associated with hand sanitizers, 16 of which involved methanol poisoning. Moreover, 7 of these cases were directly linked to hand sanitizers manufactured in Mexico. The FDA sampled and tested shipments of the hand sanitizer products manufactured in Mexico and confirmed the presence of methanol in the products linked to each of these 7 deaths.
“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. 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. This marks the first time the FDA has issued a countrywide import alert for any category of drug product,” – was commented in the article.
The Preventing Actions
The agency continues to take action to help prevent potentially dangerous or violative hand sanitizers from entering the United States by placing specific products on import alert, proactively working with companies to recall products and encouraging retailers to remove violative products from store shelves and online marketplaces.
As part of these actions, the agency has also issued 14 warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims—including incorrectly stating FDA approval—and improper manufacturing practices. The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers.
The agency reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination.
“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, Pharm.D., FDA Associate Commissioner for Regulatory Affairs.
“Today’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.”