FDA Update on Proposal for a Unified Human Foods Program

Public health emergency response and other updates from FDA since our last MCMi email include:

• June 27 2023: FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs including transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA.
• June 27, 2023: FDA Roundup including new frequently asked questions and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule.
• June 23, 2023: FDA Roundup including an updated Consumer Update to remind parents about the dangers of accidental exposure to nicotine-containing e-liquids.
• June 20, 2023: FDA Roundup including release notice of release of 2017-2018 Report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-service Restaurants.  
• June 16, 2023: FDA Roundup including information about updated COVID-19 vaccines for use in the U.S. beginning in fall 2023
• June 14, 2023: Know Your Treatment Options for COVID-19 (updated)
• June 14, 2023: If you missed the FDA Science Forum, recordings are available, including medical countermeasures, infectious diseases, and pathogen reduction technologies, & product development and manufacturing, including advanced manufacturing. Don't miss 200+ posters about FDA research!

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023, to discuss and make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023. (A recording is available.)

For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall of 2023, the committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Following discussion of the evidence, the committee expressed a preference for XBB.1.5. Also see: Recommendation for the 2023-2024 Formula of COVID-19 vaccines in the U.S. (PDF) (June 16, 2023)  

EUA revocations

FDA revoked the following EUAs for the reasons noted in the revocation letters (PDFs): 

• June 21, 2023: Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• June 15, 2023: BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Co.)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. 

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.