Cell-Based Meat, Part 4: Regulation

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After plant-based beverages were allowed to use the term “milk” by the Food and Drug Administration (FDA), the animal agriculture industry was wary of how cellular agriculture would be regulated, named and marketed. In April, “federal regulators came up with a compromise: The FDA and USDA will oversee cell-based meat, with the USDA in charge of the production and labeling. But Congress may yet try to take FDA out of the oversight process together, and leave the USDA in charge of regulating the most fundamental change in meat production since people began raising animals for food.”

Why the confusion?

The FDA and the USDA have distinct roles and functions. Officially, the purpose of the FDA is to “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” The USDA “administers programs to help American farmers and ensure food safety for consumers. USDA aid includes distributing price supports and other subsidies to farmers, inspecting food processed at agricultural facilities, working to expand overseas markets for U.S. agricultural products, and providing food assistance and nutrition education.”

The FDA regulates more than just food and drugs. It also regulates medical devices, cosmetics, tobacco products, veterinary medicines, and more.

Unfortunately, cellular agriculture does not fit easily into either of these sectors. What the product is called and how it is labeled and marketed will have impacts on how it needs to be regulated. In an interview with NPR, Mark Dopp, North American Meat Institute’s senior vice president for regulatory affairs and general counsel said, “If these products are going to be marketed and sold and represented as meat, then the companies that make them should meet all of the other regulatory requirements that some company making ground beef out there has to meet today.”

Cell-based meat companies are also eager for regulation. Industry needs regulations to grow. Without regulations, anyone could sell the product, potentially causing sickness and disease, and the public will not trust the product. Without regulations, cell-based meat companies would have difficulty selling and marketing their products.

What is the compromise?

Under the agreement, FDA will oversee cell collection, cell banks and cell growth. The USDA will then take it from there to oversee how the food is produced and how it is labeled.” I am still not sure exactly how this will play out. Given that this is an emerging technology, I think there may be some details to iron out between now and when the product is on the market.

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