The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA issued a statement, “Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Address Safety Concerns,” to discuss the Agency’s efforts to increase availability of alcohol-based hand sanitizer and the importance of making hand sanitizer unpalatable to people, including children, through the use of denatured alcohol. Calls to the National Poison Data System last month related to hand sanitizer increased by 79 percent compared to March 2019, with the majority of these calls accounting for unintentional exposures in children 5 years of age and younger. The statement also warns consumers about hand sanitizer sold with fraudulent claims.
- The FDA developed a fact sheet in collaboration with the Centers for Disease Control and Prevention (CDC) to help answer questions from the food and agriculture sector about what respirators, disposable facemasks, such as surgical or medical masks, or cloth face coverings are most appropriate for various settings.
- The FDA also developed a fact sheet, What to Do If You Have COVID-19 Confirmed Positive or Exposed Workers in your Food Production, Storage, or Distribution Operations Regulated by FDA, derived from CDC recommendations. This fact sheet summarizes key steps that employers and workers can take to help stay open, prevent and slow the spread of COVID-19, and support continuity of essential operations if workers are diagnosed with or exposed to COVID-19, or show symptoms associated with COVID-19.
- After receiving questions and concerns about the Emergency Use Authorization (EUA) for face masks posted on April 18, 2020, the FDA updated and re-issued the EUA. In doing so, the FDA clarified that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control. These face masks are not authorized to be personal protective equipment, meaning they are not a substitute for filtering face piece respirators or surgical face masks. The FDA also posted FAQs on the Emergency Use Authorization for Face Masks (Non-Surgical).
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 49 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 21 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 225 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
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.