Joel E Roberson is Partner in Holland & Knight's Washington D.C. office
Sara M Klock is Associate in Holland & Knight's Washington D.C. office
Jennifer M Nowak is Associate in Holland & Knight's Washington D.C. office
On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement announcing the agencies' joint regulatory framework for cell-cultured food products derived from livestock and poultry. The need for collaboration between the two agencies with regard to animal cell-cultured food technology – which the agencies have described as "the controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cell types, and their collection and processing into food" – arises from the overlap of USDA's statutory mandate to regulate meat and poultry products and FDA's statutory responsibility for the safety of the national food supply, as well as FDA's experience in regulating cell-based technology.
This announcement follows a Federal Register Notice issued on Sept. 13, 2018 and a joint public meeting held on Oct. 23-24, 2018, by the two agencies, where FDA and USDA discussed the "potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry tissue" with stakeholders and the public. Under the framework, FDA will be primarily responsible for overseeing cell collection, cell banks, and cell growth and differentiation," while USDA will be primarily responsible for regulating the production and labeling of food products derived from these cells. The agencies anticipate that the transition of oversight from FDA to USDA will occur "during the cell harvest stage."
FDA and USDA are actively reviewing the details of the framework, including collaboration and information sharing. FDA and USDA do not anticipate enacting legislation to conduct their respective roles, as the agencies believe they "have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry." In order to allow for consideration of the joint statement issued on Nov. 16, 2018 and stakeholder feedback from the public meeting held on Oct. 23-24, 2018, the agencies have extended the original public comment period associated with the public meeting by one month, until Dec. 26, 2018.
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