USDA and FDA Publish the Terms of Their Joint Regulation of Human Food, Derived from Cell Lines of USDA-Amenable SpeciesMarch 11, 2019
As readers of this blog may recall, the issue of the regulation of meat and poultry derived from cell lines, identified by such terms as cultured meat, clean meat, and cell-based meat, became front cover news a little more than a year ago when the U.S. National Cattlemen’s Association (USCA) filed a Petition with FSIS to define the term meat (and beef) to exclude these types of food prepared from cells from cattle.
Subsequently, the question as to who has jurisdiction, FDA or USDA, became a hotly debated topic. On November 16, 2018 in a joint press release, USDA and FDA announced that they had come to an agreement on a joint regulatory framework under which FDA would oversee cell collection, cell banks, and cell growth and differentiation, and USDA oversight would start during the cell harvest stage and extend through the production and labeling of food products derived from the cells of USDA amenable species, i.e., livestock and poultry. Details were said to be forthcoming.
On March 7, 2019, USDA and FDA announced the “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” providing further information about the agreed framework. Consistent with the press release from Nov. 2018, FDA will oversee the production of the cells and then jurisdiction will transition to USDA during the cell harvest stage. The agreement is general and the exact parameters of the regulation of these products still need to be developed. Some noteworthy aspects:
- The Agencies contemplate a premarket consultation process “to evaluate production materials/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs.”
- The facilities where the cells will be grown and harvested will be dual jurisdiction facilities.
- While in Nov. 2018 the Agencies asserted that no additional legislation would be necessary, the formal agreement includes a provision that FDA and USDA “will undertake a joint process to identify any changes needed to statutory or regulatory authorities to effectuate” the agreement.
- The agreement refers to the product category as “food, derived from cell-lines of USDA-amenable species” or similar terms, thereby leaving the issue of naming these products for another day.
- FDA explains the basis for its jurisdiction over these products; USDA does not. The agreement refers to meat and poultry products that bear the mark of inspection and in the press release USDA Deputy Under Secretary mentions that “Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products.” This suggests a loss for USCA, as its Petition requested to not allow products derived from cell lines to bear the mark of inspection.
In light of the various States proposing (e.g. Nebraska) or passing laws (e.g., Missouri) prohibiting the term meat on foods derived from cell lines, the agreement between FDA and USDA may not be the end of the debate.