Knobbe/Martens: Intellectual Property Law

FDA and USDA Enter into Formal Agreement to Jointly Regulate Cell-Cultured Food Products

By Simone V. Ward, Ph.D. and Jason J. Jardine March 19, 2019

On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a memorandum of understanding (MOU), to jointly regulate the production of human food derived from cultured cells of livestock and poultry, including cell-based meat.  [1], [2]  The FDA is an agency of the U.S. Department of Health and Human Services (HHS), and the FSIS is an agency of the U.S. Department of Agriculture (USDA).  The MOU follows a joint public meeting held in October 2018 at which the Agencies discussed the use of cell culture technology for human food production, including potential hazards, oversight, and labeling, with representatives of industry, consumer groups, and other stakeholders.  [3]  The October 2018 meeting resulted in a statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on November 16, 2018, confirming that the Agencies had agreed to joint oversight of this emerging technology.  [4]

The MOU announced in March 2019 recognizes that each Agency has an important role in the oversight of human food derived from cell culture material.  [5], [6]  FDA derives its statutory authority from the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.).  Under these statutes, FDA is tasked with ensuring that food is not adulterated or misbranded by conducting inspections of manufacturing facilities and vehicles of transportation.  FSIS’s role includes inspections of meat and poultry slaughter and processing facilities and egg product processing plants, pursuant to the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451, et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031, et seq.).

The MOU describes the roles of FDA and USDA in the oversight of cultured cell-derived food for human consumption.  FDA will conduct pre-market consultations and oversee initial cell collection, maintenance of cell banks, and cell growth and differentiation.  FDA will also ensure compliance of facilities with Current Good Manufacturing Practices (cGMP), conduct inspections, and take enforcement actions as necessary.  Both FDA and FSIS will coordinate transfer of regulatory oversight to FSIS at cell harvest.  FSIS will require establishments that harvest cells from livestock or poultry subject to the FMIA or PPIA to bear the USDA mark of inspection and oversee processing into human food products, packaging, and labeling.  Each Agency has also agreed to share information with the other, as authorized by law.

The MOU is a non-binding agreement.  The Agencies also have agreed to develop a more detailed framework to facilitate shared regulatory oversight, to work together on product labeling, cooperate in investigations of food safety, and to jointly identify necessary statutory or regulatory changes.  [5], [6]  

 

[1]See https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632916.htm

[2]See https://www.usda.gov/media/press-releases/2019/03/07/usda-and-fda-announce-formal-agreement-regulate-cell-cultured-food

[3]See https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619987.htm

[4]See https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626117.htm

[5]See https://www.fda.gov/Food/InternationalInteragencyCoordination/DomesticInteragencyAgreements/UCM632752.htm

[6]See https://www.fsis.usda.gov/formalagreement

 

Meet the Knobbe Martens Attorneys

FDA and USDA Enter into Formal Agreement to Jointly Regulate Cell-Cultured Food Products
Simone Ward, Ph.D., is an associate in the San Diego office of our firm. Simone’s practice focuses primarily on patent prosecution in the life sciences and biotechnology fields....
FDA and USDA Enter into Formal Agreement to Jointly Regulate Cell-Cultured Food Products
Appreciated for his strategic analysis and solutions that fit each client’s specific needs, Jason Jardine represents a diverse clientele in all aspects of intellectual property...
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