The U.S. Food and Drug Administration yesterday announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued an immediately in effect guidance that outlines a temporary policy to help expand the availability of portable cryogenic oxygen and nitrogen containers. The demand for these critical medical gases is expected to rise during the pandemic and may result in a shortfall of portable cryogenic medical gas containers that meet regulatory requirements. The FDA does not intend to take enforcement action against firms that fill and distribute oxygen and nitrogen in portable cryogenic medical gas containers that do not comply with certain regulatory requirements, provided that alternative, specific safeguards are in place to prevent gas mix-ups. This guidance will be in effect until the end of the public health emergency.
- The FDA issued information and best practices for retail food stores, restaurants, and pick-up and delivery services during the pandemic to protect both workers and customers. Information shared includes smart food safety practices that employers can consider at any time. It is being issued in two convenient formats.
- Due to the potential risk of transmission of SARS-CoV-2 through Fecal Microbiota for Transplantation (FMT), the FDA updated information on its website pertaining to safety protections regarding the use of FMT, informing healthcare providers about screening donors for COVID-19 and exposure to and testing for SARS-CoV-2. This update follows a safety alert posted on March 23, 2020. The FDA has determined that additional protections are needed for any investigational use of FMT, whether under an investigational new drug application on file with FDA or under FDA’s enforcement discretion policy.
- The FDA and Federal Trade Commission (FTC) issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Free Speech Systems LLC, DBA Infowars.com, offers unapproved and misbranded products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 270 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, 32 emergency use authorizations have been issued for diagnostic tests.
- The FDA has been notified that more than 150 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.