Summation
- Food and Drug Administration’s 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.
- The FDA recently issued a guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.
- 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.
January 26, 2021
As part of the U.S. Food and Drug Administration’s 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.
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.
“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.”
The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. The agency has posted and regularly updates a list of hand sanitizer products that consumers should not use, which include those that FDA has found to contain methanol and/or 1-propanol. In most cases, methanol does not appear as an ingredient on the product label.
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. The FDA recently issued a guidance outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.
Methanol-contaminated hand sanitizers are a serious safety concern, and the FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute are most at risk.
Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning. The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information to identify the product as possible). For more information, consumers should refer to the FDA’s guidelines on safe use of hand sanitizer as well as a question and answer page.
