The U.S. Food and Drug Administration (FDA) announced Tuesday the following actions in the ongoing response to the COVID-19 pandemic:
- The FDA issued a new Consumer Update entitled, Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use? FDA testing has uncovered that some hand sanitizers carry toxic ingredients. The Consumer Update provides information to find out if your product is on the list. Before you buy hand sanitizer or use hand sanitizer you have at home, the FDA recommends checking its do-not-use list at www.fda.gov/handsanitizerlist, including the description on how to use the list. The agency updates the list regularly as new test results are released.
- The FDA approved an Abbreviated New Drug Application for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation. Albuterol sulfate inhalation aerosol 90 will be used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients four years of age and older. The most common side effects associated with albuterol sulfate inhalation aerosol are headache, rapid heart rate (tachycardia), pain, dizziness, sore throat (pharyngitis), and rhinitis. The FDA recognizes the increased demand for certain products, like albuterol, during the novel coronavirus pandemic and remains deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
- Testing updates:
- To date, the FDA has currently authorized 221 tests under EUAs; these include 179 molecular tests, 39 antibody tests, and 3 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.