A Possible Solution to the Jurisdictional Issues Related to Cultured Meat; Have FDA and USDA Share the Responsibility

As we previously reported, the most critical issue facing the animal cell cultured industry is a need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction over which aspects of production and distribution. Earlier this year, the discussion heated up when the U.S. Cattlemen’s Association filed a Petition asking USDA to define meat so that it would exclude products created by animal cell culture. .  Other parties in the animal industry, however, argued that USDA should assert jurisdiction over these products to level the playing field.   Then, maybe somewhat unexpectedly to some in the industry, FDA announced a public meeting that suggested that FDA was claiming jurisdiction. Subsequently, on June 27, 2018, there was a congressional briefing on cellular agriculture on Capitol Hill, hosted by Research & Development (R&D) Caucus co-chairs, Representative Bill Foster (D-IL) and Representative Barbara Comstock (R-VA). In addition, there were several legislative efforts to place cell cultured meat and poultry under USDA jurisdiction.

An Aug. 23, 2018 letter to President Trump cosigned by Memphis Meats and the North American Meat Institute (NAMI) suggests a possible solution to this turf war. In the letter, NAMI and Memphis Meats propose that FDA should have oversight of pre-market safety evaluations for cell-based meat and poultry products. Then once safety is established, USDA should regulate cell-based meat and poultry products, as it does with all other meat and poultry products.  In certain respects, the proposed approach is not new.  In fact, with new ingredients intended for use in meat or poultry a similar approach is applied; under an MOU established in 2000, FDA and USDA cooperate in the review of such ingredients.

The authors of the letter suggest that the proposed approach plays into the strengths and experience of both agencies. They request a combined meeting between the White House, USDA, FDA and both conventional and cell-based meat and poultry industry stakeholders.

We will be monitoring developments.