The FDA Issues Warnings for Hand Sanitizers Contaminated with Methanol or 1-Propanol
As the COVID-19 pandemic remains a prevalent public health crisis, the purchase and use of hand sanitizers have been on the rise. Hand hygiene is a crucial practice to combat the spread of SARS-CoV-2. When water and soap are not readily available for handwashing, the US Center for Disease Control and Prevention (CDC) recommends the use of alcohol-based hand sanitizers that contain at least 60% ethanol (also known as ethyl alcohol) or 70% isopropanol as the active ingredient to sufficiently inactivate SARS-CoV-2 (CDC, 2019). However, methanol and 1-propanol, common alcohols used in the fuel industry and in the production of other chemicals, are not ingredients recommended by the US Food & Drug Administration (FDA) for use in hand sanitizers (FDA, 2020).
On June 19, 2020, the FDA issued a warning that urged consumers to not use hand sanitizers that were contaminated with methanol (FDA, 2020). Further, on August 12, 2020, the FDA expanded its warning for hand sanitizers to also include products contaminated with 1-propanol. Specifically, the FDA noted that these products claimed to contain ethanol or isopropyl alcohol, but were confirmed to be contaminated with methanol or 1-propanol after testing.
While all persons who use these contaminated hand sanitizers are at risk, young children who incidentally ingest contaminated hand sanitizers, as well as adolescents and young adults who purposefully drink contaminated hand sanitizers as an alcohol or ethanol substitute, are most at risk for methanol or 1-propanol poisoning. Both methanol and 1-propanol have been shown to be more toxic than ethanol following oral exposure and both lead to severe gastrointestinal and central nervous system effects (Litovitz, 1986). Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, and permanent damage to the nervous system, or death (FDA, 2020; Chan & Chan, 2018). 1-Propanol exposure can result in confusion, decreased consciousness, as well as slowed pulse and breathing. Specifically, the ingestion of 1-propanol-contaminated hand sanitizers can cause central nervous system depression and potentially death.
The full list of hand sanitizer products documented by the FDA as contaminated with methanol or 1-propanol, and thereby deemed unsafe for use, can be found here. Consumers and businesses who are in possession of hand sanitizer products identified on this list should immediately stop the use of the product and properly dispose of it as hazardous waste. Check with your local environmental, health, or solid waste agency for more information on hazardous waste management options in your area. If hand sanitizer is ingested, please call the Poison Help hotline at 1-800-222-1222. Further, consumers and businesses can report any adverse events related to the use of hand sanitizers to an online form through the FDA’s MedWatch Adverse Event Reporting program.
Cardno ChemRisk has assisted companies in understanding potential product exposures and risks, and in assisting companies in a variety of industries with developing and evaluating COVID-19 response plans. Learn more about the ways Cardno ChemRisk can support your business on our website. Our scientists have evaluated diverse scenarios for product compliance, ranging from a single product to entire product lines. For more information regarding Cardno ChemRisk’s capabilities, please contact Jillian Parker and Melissa Vincent.