FDA continues to take action in the ongoing response to COVID-19 pandemic

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

• The FDA is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand sanitizers are being packaged in beer cans, children's food pouches, water bottles, juice bottles and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry. Manufacturers should be vigilant about avoiding packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers. Hand sanitizer can be toxic when ingested. Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer.The FDA continues to monitor these products and will take appropriate actions as needed to protect the health of Americans.

• The FDA issued Abbott Diagnostics Scarborough, Inc. an emergency use authorization (EUA) for its BinaxNOW COVID-19 Ag Card antigen test. This is the first COVID-19 diagnostic test that a health care provider can perform without an analyzer, meaning that test results can be read directly from the testing card. This rapid COVID-19 antigen test detects fragments of proteins found on or within the virus.  The test is authorized for use on individuals suspected of COVID-19 by their healthcare proider within the first seven days of symptom onset by using swabs to collect samples from the nasal cavity. The test is authorized for point-of-care settings, like a doctor's office, emergency room, or some schools, operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.  

• Testing updates:
  • To date, the FDA has currently authorized 226 tests under EUAs; these include 182 molecular tests, 40 antibody tests, and 4 antigen tests.

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.