FDA Update to Hand Sanitizers with Methanol
In July 2020, consumers were shocked to learn that many of the hand sanitizer products sold in the US were made with high levels of methanol. The FDA immediately began recalling those products that tested with over 1% methanol and those that were proven to contain other contaminants. The FDA regulates sanitizers sold in the US and requires the products to be properly labeled and contain at least 60% ethyl alcohol or 70% isopropyl alcohol to kill germs, viruses, and bacteria on hands.
Ethanol typically provides the alcohol base for hand sanitizers. But, it was discovered that 85 out of the 86 products listed on the FDA’s hand sanitizer recall list contained high levels of methanol. As an over-the-counter drug product, hand sanitizers must meet strict FDA regulations. This includes the use of United States Pharmacopeia (USP) Grade ethanol that is tested for purity. Methanol is allowed to be present in manufactured hand sanitizers, but only at extremely low levels.
With a spike in demand for hand sanitizers due to the worldwide Coronavirus outbreak, there have been numerous reports of fraudulent marketing (products erroneously labeled), and products that were contaminated (with high levels of methanol). It is important to know why methanol is unsafe and how to determine if your hand sanitizer meets FDA regulations.
Why is methanol unsafe to use?
Methanol is a toxic substance and is not an acceptable ingredient for hand sanitizers. Methanol, is also referred to as wood alcohol because it was once made by the distillation of wood, It is toxic to humans and animals when absorbed through the skin or ingested. Methanol has many industrial uses including its use as a solvent and alternative fuel source. Safe levels of methanol are also present in diet soft drinks that contain aspartame, fresh fruits, and vegetables.
However, the synthetically produced substance, methanol is poisonous. At high levels, methanol toxicity can have many side effects and ill symptoms including headaches, nausea, vomiting, and blurred vision. If exposure continues, there can be a negative effect on the optic nerve which can lead to blindness and a lack of oxygen supplied to the brain which can cause loss of coordination and/or loss of consciousness.
Choosing a safe hand sanitizer
Before the COVID-19 pandemic, all hand sanitizers sold in the U.S. had to be made at FDA-registered facilities and tested for adherence to very strict impurity limits. When USP Grade ethanol is used, may contain some methanol – at very low levels. When the FDA temporarily relaxed their policies to meet the growing demand for hand sanitizers, these below-quality products found their way from Mexico and into American homes.
Although currently not required, it is best to always choose a manufacturer of hand sanitizers that uses as its primary active ingredient – USP (U.S. Pharmacopoeia) Grade ethyl alcohol or USP Grade Isopropyl Alcohol that meets FDA requirements. It is best to use an alcohol-based hand sanitizer that contains at least 60% alcohol. Finally, you always want to choose a product that is registered with Food and Drug Administration (FDA).
Check the list of banned hand sanitizers as produced by the FDA, before you purchase. If you have any unopened or unused hand sanitizers that may contain methanol, it is recommended that you dispose of the product as you would any other hazardous material. Do not flush or pour them down the drain or mix with other products. Visit Betco online to learn more about disinfecting solutions and hand hygiene.