The US Food and Drug Administration (FDA) has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
The FDA has updated their 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 the 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, the agency 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 healthcare professionals or for individuals and their families.
Although some larger hospital systems have been able to replenish their supply of hand sanitizer, FDA continues to hear that some smaller hospital systems and outpatient facilities are still experiencing difficulties accessing alcohol-based hand sanitizers and 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.
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).
The FDA 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, they 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.
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.
