Cell-Cultured Meat: Who Will Regulate, FDA or USDA?

Does the Food and Drug Administration (FDA) have the regulatory tools and experience necessary to regulate cell-cultured “meat”?

In a public meeting on July 12, 2018, FDA discussed how meat produced using cell-culture technology fits under its current regulatory framework for food safety.1,2 Does this mean that FDA does not view cell-cultured “meat” to be a “meat food product,”3 which would traditionally be regulated under the jurisdiction of the United States Department of Agriculture (USDA)? If the food ingredients produced from cell-cultured technologies were regulated under FDA’s jurisdiction, the food ingredients would be required to meet the food safety standard of “reasonable certainty of no harm” under the intended conditions of use of the ingredient or product. Regulations established under the Food Safety Modernization Act (FSMA) would also be enforced by FDA to ensure risk-based approaches are applied to control potential h