Understanding the FDA’s announcement on hand sanitizers containing methanol
Since June 2020, the FDA has issued warnings to not use certain hand sanitizers due to testing showing a contamination of methanol. As the COVID-19 pandemic has increased the demand for hand sanitizing products, the demand for pharmaceutical alcohol as the active ingredient has also increased. This increased stress on the supply chain has made ingredients more vulnerable to economically motivated adulteration.
On January 26, 2021, the FDA took decisive action to place all alcohol-based hand sanitizers from Mexico on an import alert. This import alert is to prevent entry of violative and potentially dangerous products into U.S. and to protect consumers. However, those hand sanitizers from Mexico that are allowed entry are subject to heightened FDA scrutiny, and the FDA may detain shipment if necessary.
What is methanol?
Methanol is a nondrinking type of alcohol (also known as wood alcohol and methyl alcohol). Industrially, methanol is a toxic, colorless, volatile flammable liquid alcohol, made chiefly by oxidizing methane. Its principal uses are in fuel, solvent, and antifreeze. Methanol is a hazardous chemical that can cause poisoning, systemic acidosis, optic nerve damage, and central nervous system (CNS) effects. It can also degrease the skin which may cause dermatitis.
Methanol also occurs naturally in humans, animals, and plants. Foods such as fresh fruits and vegetables, fruit juices, fermented beverages, and diet soft drinks containing aspartame are the primary sources of methanol in the human body. Most methanol poisonings occur when drinking beverages contaminated with methanol or from drinking methanol-containing products. According to National Institute of Health (NIH) 2 to 8 oz. of methanol can be fatal to an adult.
Why the precautions?
Well over the course of the pandemic the country has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed into the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizers or any other drugs.
Under the import alert, the FDA’s entry review process will consider specific evidence offered by importers or the manufacturers that the hand sanitizers were manufactured according to the good manufacturing practice requirements of the U.S. This marks the first time the FDA has issued countrywide import alert for any drug product category.
Why the scrutiny?
The sample analysis conducted – during April through December 2020 – by the FDA of alcohol-based hand sanitizers imported from Mexico found 84% were not in compliance. More than half were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. During this time frame the agency posted regular updates of a list of sanitizers that consumers should not use. In most cases methanol was not listed in the ingredients.
Methanol-contaminated hand sanitizers are a serious safety concern. Therefore, the FDA is regularly warning the public of the adverse effects that can include blindness, cardiac arrest, effects on the central nervous system and hospitalizations. Methanol exposure can result in nausea, vomiting headache, blurred vision, permanent blindness, seizures, coma, permanent damages to the nervous system or death. The groups most at risk are those that may ingest and drink these products young children, adolescents, and adults.
For more information on this recent import alert, please consult the FDA’s website. Additionally, if you or anyone you know may have ingested or drank a methanol-contaminated hand sanitizer and needs help, please contact Poison Help at 800-222-1222 immediately to connect to your local poison center.