Cell-Cultured Food Regulations

This issue tracker addresses the USDA and FDA rulemaking process for cell-cultured meat. Legislation, regulations and litigation relating to labeling of cell-cultured meat products are addressed in the Meat Labeling Law issue tracker. This issue tracker covers the period from 2018 to present. 

***

6.21.23 – Upside Foods announced that the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued the company a Grant of Inspection (GOI), marking the successful completion of the pre-market regulatory review process and allowing Upside Foods to produce and distribute their cell-cultured chicken in the United States. The USDA approval comes after the company received a “No Questions” letter from the U.S. Food and Drug Administration (FDA) on November 16, 2022, and obtained label approval from the USDA on June 14, 2023. Upside Foods expressed their satisfaction with the approval, stating “Now that we’ve received clearance to begin commercial production, we can proceed with scaling up our operations.” It is important to note that Upside Foods’ cell-cultured chicken will be subject to the same inspection process and bear the USDA seal as conventionally produced meat.

3.21.23 – The U.S. Food and Drug Administration (FDA) completed its second pre-market consultation for a cell-cultured food product developed by GOOD Meat, Inc., a Californian-based subsidiary of Eat Just. GOOD Meat, Inc. uses animal cell culture technology to cultivate chicken cells in a controlled environment, aiming to produce cultured animal cell food for human consumption. While the pre-market consultation does not grant approval, it indicates that the FDA has thoroughly reviewed the date and has found no additional safety concerns. Prior to entering the U.S. food market, cultured animal cell food must meet FDA requirements and undergo inspection by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS). 

11.16.22 – The U.S. Food and Drug Administration (FDA) issued a news release announcing it completed the first pre-market consultation for human food derived from animal cell culture technology. UPSIDE Foods, a Californian-based food technology company, submitted information about their products derived from chicken cells and FDA stated there are no further questions about the company’s “safety conclusion.” FDA wrote, “In addition to meeting the FDA’s requirements, including facility registration for the cell culture portion of the process, the firm will need a grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. Additionally, the food itself requires a mark of inspection from USDA-FSIS before it can the U.S. market.” 

10.19.22 – The U.S. Food and Drug Administration (FDA) announced two final guidance documents for producers of animal cells, tissues, and cell- and tissue-based products (ACTPs): Guidance #253: Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products and Guidance #254: Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products. ACTPs are “products that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion, or transfer into an animal recipient” and are most commonly used in dogs, cats, and horses, but may be further cultivated for other species. Guidance #253 provides ACTP producers with instructions regarding facilities, processing, distribution, and contamination prevention to meet current good manufacturing practices under the Federal Food, Drug, and Cosmetic Act (FDCA). Guidance #254 recommends that ACTP donors should only be eligible if the donor tests negative and presents no signs of any relevant diseases. Both documents were published for comment in September 2022 and incorporated public feedback received by FDA. 

10.7.20 – FDA issued a notice in the Federal Register requesting information regarding the labeling of foods comprised of or containing cultured seafood cells. According to the notice, foods comprised of or containing cultured seafood cells will soon be put on the market and FDA would use available information and data to determine what regulatory actions are needed. The public comment period will close on Mar. 8, 2021.

4.7.20 – The U.S. Government Accountability Office (GAO) issued a report, titled “FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat,” to the Honorable Rosa DeLaura, chairwoman of the House of Representatives Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations. In this report, the U.S. GAO “(1) describes what is known about methods for commercially producing cell-cultured meat and (2) examines the extent to which FDA and USDA are collaborating to provide regulatory oversight of cell-cultured meat.”

3.7.19 – USDA and FDA released a formal agreement, which sets out the responsibilities and roles of the two agencies in overseeing cell-cultured meat production, processing and labeling. 

9.13.18 – USDA and FDA issued a Notice announcing a “Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry” scheduled on October 23-24, 2018 in Washington D.C. 

6.18.18 – FDA published in the Federal Register a notice of public meeting, titled “Foods Produced Using Animal Cell Culture Technology,” to be held on July 12, 2018 in College Park, MD. 

6.15.18 – FDA issued a statement that the agency has regulatory authority over cell-cultured food products: “Under the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over ‘food,’ which includes ‘articles used for food’ and ‘articles used for components of any such article.’ Thus, as a starting point, both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to the FDA’s jurisdiction.”

***

Note: This section intends to only refer to introduced or adopted legislation at the state level, which directly relates to the regulatory process of cell-cultured meat products. Any legislation relating to the labeling and advertising of cell-cultured meat products will be addressed in the Meat Labeling Law Issue Tracker. 

***

***