FDA Rolls Out Temporary Testing Protocols For Hand Sanitizer Due To Methanol Concerns

Amid growing problems with hand sanitizer products that contain potentially harmful methanol ingredients, federal drug officials have released new guidance for manufacturers to test for the presence of contamination.

The U.S. Food and Drug Administration (FDA) announced the hand sanitizer testing guidance on August 7, outlining a series or procedures for manufacturers to test for methanol, which is a wood alcohol that can be toxic when absorbed through the skin or potentially life threatening if ingested.

In recent months, as demand for hand sanitizers has increased amid the COVID-19 pandemic, an influx of methanol-containing hand sanitizers have entered the U.S. market, even though methanol is not approved for use in topical sanitary products, due to its potentially harmful side effects.

The FDA has been closely monitoring the influx of unapproved products circulating through U.S. retailers and has issued over 100 hand sanitizer recalls to date for either containing methanol or having lower than disclosed levels of ethanol or isopropyl alcohol, which give consumers a false sense of security that the products have killed germs.

The new hand sanitizer testing guidelines require manufacturers to have each lot of the active ingredient tested in a laboratory compliant with the FDA’s good manufacturing practices.

In addition, the agency has set a 630 parts per million (ppm) limit on the acceptable amount of methanol detected in ethanol or isopropyl alcohol. According to the guidance, any alcohol products containing more than 630 ppm are subject to adulteration charges under the FD&C Act, and are to be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.

The guidance follows several methanol hand sanitizer warnings released by the FDA which have indicated the risk of methanol poisoning from hand sanitizers has increased significantly due to the products being sold in bright colors, with scents similar to candy and some even packaged with glitter or fun characters on the bottle, which makes them particularly appealing to young children.

Methanol is often used to make fuel and antifreeze, but including it can cause side effects like headache, nausea, vomiting, blurred vision, seizures, blindness, coma, permanent damage to the nervous system and death.

Among popular brand of hand sanitizer that have been recalled are KLAR and DANVER Instant Hand Sanitizer), Britz, Born Basic Anti-Bac, AAA Cosmetica, Earth’s Amenities Instant Unscented Hand Sanitizer, Modesa Instant Hand Sanitizer Moisturizers and Vitamin E, Hello Kitty by Sanrio Hand Sanitizer, Assured Aloe, and multiple versions of Blumen Instant Hand Sanitizers.

To date, the FDA has become aware of several reports of adults and children ingesting the hand sanitizer products contaminated with methanol, which have resulted in methanol poisonings and  adverse health events including blindness, hospitalization and death.

The FDA and U.S. Centers for Disease Control and Prevention (CDC) recommend consumers always wash their hands with soap and water before using a topical hand sanitizer, as currently there is no scientific evidence it is a more effective means of killing germs over normal hand washing.

However, if topical hand sanitizers must be used they should contain at least 60% ethyl alcohol or isopropyl alcohol to be effective in killing germs on the skins surface, the FDA advises.