June 2, 2020 - The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. Consumer and health care personnel safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, including as we seek to increase supply of hand sanitizer. To that end, we have updated our guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer.
The FDA appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic. Early on during the public health emergency, as demand for alcohol-based hand sanitizer had dramatically increased, we issued temporary policies to provide flexibility to help meet this demand and to help get supply quickly to where it was needed, whether it was for health care professionals or for individuals and their families.
Although it is our understanding that some larger hospital systems have been able to replenish their supply of hand sanitizer, we continue to hear that some smaller hospital systems and outpatient facilities are still experiencing difficulties accessing alcohol-based hand sanitizers. We also recognize that some consumers may not be able to find alcohol-based hand sanitizer in their local area, and, when they do, it is in limited quantities. Washing our hands with soap and water, for at least 20 seconds, continues to be one of our best defenses to prevent the spread of COVID-19. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol).
We previously updated these temporary guidances in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents). These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers.
The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.
As with everything we do, the FDA is committed to ensuring that we appropriately balance risk and benefit. We believe that our temporary guidances sets the proper level of flexibility at the current time to help protect Americans during this public health emergency. We do not make any decision lightly and are continually assessing the needs and circumstances related to our temporary policies and how best to protect public health. As relevant needs and circumstances evolve, the FDA intends to update, modify or withdraw these policies as appropriate.
Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov or visit the Frequently Asked Questions on Hand Sanitizer on the FDA’s website. As increased hand sanitizer supply becomes available, consumers are reminded to keep hand sanitizers out of the reach of children (who may swallow hand sanitizers, particularly if they are scented, brightly colored or attractively packaged) and, in case of ingestion, to get medical help or contact a Poison Control CenterExternal Link Disclaimer immediately. Very small amounts of hand sanitizer can be toxic, even lethal, to young children. Therefore, it is advisable that children should use such sanitizers with adult supervision.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.