March 11, 2019
Authored by: 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: