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In almost any area where an emerging technology intersects with a highly regulated industry, there is a dynamic of entrepreneurial spirit facing the realities of existing regulatory frameworks. One novel product facing this dilemma is “cell-cultured meat” (CCM)—meat grown in a cell culture instead of culled from an animal.

CCM is part of a new and emerging area of biotechnology known as “cellular agriculture” through which agricultural products are produced from the cellular level rather than taken from the whole plant or animal. Proponents of cellular agriculture highlight the process as creating a more sustainable, efficient, and predictable food supply, and the National Academy of Sciences estimates products of cellular agriculture will be in the marketplace within the next five years.

Cellular agriculture products will test the current regulatory system’s reliance on products fitting neatly into statutory and regulatory definitions. For instance, CCM does not fit into the current definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA) because FMIA assumes a meat food product is derived from a carcass. If FMIA is not applicable, it is not clear which federal authority has jurisdiction over the product to ensure its safe use and consumption, or the process by which the product and its labeling should be reviewed.

For a comprehensive discussion of the potential regulatory challenges for CCM and products of cellular agriculture, read the article by Morgan Lewis lawyer Amaru Sanchez in the Food and Drug Law Institute’s Update magazine. 

As always, if you have any questions, please do not hesitate to contact us.