- For immediate release:
The US Food and Drug Administration (FDA) continued to take action today in its ongoing response to the COVID-19 pandemic:
- The FDA warns consumers about alcohol-based hand sanitizers that are packaged in containers that may appear as food or drink and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand disinfectants are packaged in beer cans, baby bottles, water bottles, soup bottles and vodka bottles. In addition, the FDA has found hand sanitizers that contain food flavors, such as chocolate and raspberries. Manufacturers need to be vigilant about avoiding packaging and marketing their handlers in food or beverage packages in an effort to potentially limit accidental use by consumers. Hand disinfectant can be toxic on ingestion. Drinking only a small amount of manual is potentially deadly to a young child, which can be attracted by a pleasant smell or brightly colored bottle of hand sanitizer. The FDA is monitoring these products and will take appropriate action if necessary to protect the health of Americans.
- The FDA approved Abbott Diagnostics Scarborough, Inc. an Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card antigen test. This is the first diagnostic test of COVID-19 that a healthcare provider can perform without an analyzer, which means that test results can be read directly from the test card. This rapid COVID-19 antigen test detects fragments of egg proteins found on or within the virus. The test is authorized for use on individuals suspected of having COVID-19 by their healthcare provider within the first seven days of symptom onset by using swabs to collect samples from the nasal cavity. The test is authorized for healthcare facilities, such as a doctor’s office, emergency room, or some schools, operating under a CLIA exemption certificate.
- Test 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 Social and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary medicines, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating our nation’s tobacco products.
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