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USDA Secretary Signals USDA Role Over Animal Cell Culture Technology Regulation Ahead of Joint USDA-FDA Meeting

  • As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. The meeting will focus on potential hazards, regulatory issues, and labeling issues. There has been an ongoing debate as to whether USDA or FDA should have regulatory jurisdiction over cultured meat, but the upcoming joint meeting may be a sign that the two agencies are looking to partner with one another.

  • As a reminder to our readers, FDA was quick to assert its interest in jurisdiction over cell-cultured meat, holding a public meeting on the issue in July without any USDA officials participating as panelists. In a continuing sign of the FDA’s interest in cell culture technology, Susan Mayne, director of FDA’s Center for Food Safety, recently noted at the Wall Street Journal Global Food Forum, “we’ve been looking at biotech products for the last 20 years. Cell-cultured meat is really in the same framework.”

  • However, in a recent interview with the Wall Street Journal, USDA Secretary Sonny Perdue called for both agencies to play a role, stating that FDA “has equity in the lab, and if it is commercialized as a product, the USDA has the responsibility to inspect that. It needs to be clearly delineated who does what.” Speaking with reporters at a North American Meat Institute event, Secretary Perdue embraced the technology, “we don’t want this new technology to feel like they’ve got to go offshore or outside the United States to get a fair regulatory protocol.” He reiterated this stance in an interview with Organic Insider, “we’ve got new technology with stem cell protein growth [referring to cell-cultured meat technology]… shouldn’t we in the United States be about how we can grow and feed people more efficiently and more effectively … these techniques need to be embraced, not kept out.”

  • It remains to be seen how such a partnership between the two agencies will play out, but the upcoming USDA-FDA joint meeting on cell culture technology will provide an opportunity for startups and traditional meat producers to provide both agencies with their input to shape the future regulatory oversight of cell-cultured meat.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...