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Cell-Cultured Meat and Cellular Agriculture Challenge Traditional Regulatory Definitions

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.

Copyright © 2018 by Morgan, Lewis & Bockius LLP. All Rights Reserved.


About this Author

Amaru Sanchez, Morgan Lewis, Life sciences lawyer

Amaru J. Sanchez provides substantive legal and strategic advice to FDA clients in matters concerning regulatory compliance, enforcement issues, and public policy. Amaru’s advice spans a variety of FDA regulated products including medical devices, software as a medical device, prescription and non-prescription drugs as well as foods and food additives.