March 11, 2019
Authored by: BCLP and Danielle Pajda
The U.S. Department of Health and Human Services’ Food and Drug Administration (“FDA”) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) formally agreed on March 7 to share regulatory authority over cell-cultured meat products (“CCM”) derived from livestock or poultry.
As we previously reported, regulatory authority over CCM has been a much contested issue. FSIS purports to have jurisdiction over CCM under the Federal Meat Inspection Act (“FMIA”), while FDA purports to have jurisdiction under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Instead of battling over jurisdiction, the agencies have decided to collaborate – both will have oversight but at different stages of production. Essentially, FDA will oversee the initial stages of production, while FSIS will take on authority during cell harvesting.
While the details have yet to be refined, the agreement broadly allocates the agencies’ respective roles and responsibilities as follows:
- Oversee initial cell collection and the development and maintenance of cell banks
- Oversee proliferation and differentiation of cells through time of harvest
- Develop additional requirements for cell bank conditions and processes
- Conduct inspections of cell banks and take enforcement action if necessary to ensure compliance with FDA’s laws and regulations
- At harvest, help coordinate transfer of oversight to FSIS and share information with FSIS
- At harvest, help coordinate transfer of oversight from FDA and review information from FDA
- Require establishments that harvest cells to obtain a grant of inspection
- Conduct inspections in establishments where cells are harvested, processed, packaged, or labeled
- Require that labeling of CCM products be preapproved and verified through inspection
- Develop additional requirements to ensure safety and accurate labeling of CCM
- Take enforcement action if necessary to prevent or remove adulterated or misbranded products from commerce For questions or more information, contact the author, Danielle Pajda, or any member of our Retail or Agribusiness and Food teams.
While the agencies previously stated that new legislation is not necessary to give them regulatory power over CCM, the agreement notes that FDA and FSIS will work together to identify any regulatory or statutory changes needed to effectuate their joint framework. Accordingly, it’s possible that more changes are on the horizon as the arrival of CCM approaches.