USDA and FDA Settle Jurisdiction over Products Derived from Livestock and Poultry Cell Lines

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and delineates the general roles that FSIS and FDA will play in regulating the developing of cell lines, culturing cells, harvesting cells, processing products from those cell cultures, labeling, and post-market enforcement. 

It builds on a November 2018 joint statement by USDA Secretary Perdue and FDA Commissioner Gottlieb last Fall, in which they announced that the agencies would establish a coordinated framework for regulating these products working within their existing statutory authorities. Although today’s formal agreement establishes a general regulatory framework, additional work remains, as both agencies will have to review and possibly update regulations, develop more specific regulatory guidance for these products, and resolve a number of important questions.

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