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Published online by Cambridge University Press: 08 May 2025
The United States is one of the largest consumers of meat globally. The traditional production of meat contributes substantially to climate change due to the levels of greenhouse gases emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Conventional meat production is also a major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.
Advocates for policy change aimed at addressing the risks currently associated with meat production have typically focused on reducing meat consumption, alternatives to meat, or improving the standards of conventional meat production. These are laudable goals, but an emerging technology now promises meat production that may avoid these risks entirely. Enter “lab-grown meat” — meat cultivated in an efficient and controlled laboratory environment without the need for fields, feed, or even animals.
The technology has been in development for over 100 years but has seen exponential growth in the past five years. What was previously considered a science fiction fantasy became a reality in the United States in 2023, when UPSIDE Foods and GOOD Meat received approval from USDA for sale of their cultivated chicken to U.S. consumers.
This article highlights the benefits and drawbacks associated with lab-grown meat, assesses the existing regulatory framework, and offers considerations for policy reform as regulators address the emergence and scale-up of this important technology.
The authors would like to thank students in the Fall 2023 FDA Law and Policy class at Saint Louis University School of Law for valuable feedback on earlier versions of this project.
1 “Lab-grown” has become one of the more popular terms to refer to this type of product. However, many of the producers, proponents, regulators, and others within the industry use a wide range of names, including “cell-based meat,” “cultured meat,” “cultured animal cell food,” “in-vitro meat,” “clean meat,” “slaughter-free meat,” “artificial meat,” “fake meat,” or “human food produced using animal cell culture technology derived from cell lines of USDA-amenable species.” For the purposes of this paper “lab-grown meat,” “cultured meat,” and “cultivated meat” will be used interchangeably. See Bruce Friedrich, Cultivated Meat: A Growing Nomenclature Consensus, Good Food Inst. (Sept. 29, 2021), https://gfi.org/blog/cultivatedmeat/ [https://perma.cc/ARH9-SUTA]. Occurrences of the aforementioned terminology may be found in, for example, Elaine Watson, Cultured Meat Cos Agrees to Replace Term ‘Clean Meat’ with ‘Cell-Based Meat’ and Form Trade Association, FoodNavigator USA (Oct. 25, 2018), https://www.foodnavigator-usa.com/Article/2018/09/10/Cultured-meat-cos-agree-to-replace-term-clean-meat-with-cell-based-meat-and-form-trade-association [https://perma.cc/SD8K-WSQP]; Human Food Made with Cultured Animal Cells, FDA (Mar. 21, 2023), https://www.fda.gov/food/food-ingredients-packaging/human-food-made-cultured-animal-cells; Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species, FDA (Mar. 7 2019), https://www.fda.gov/food/human-food-made-cultured-animal-cells/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell; Sghaier Chriki & Jean-François Hocquette, The Myth of Cultured Meat: A Review, 7 Frontiers Nutr. & Food Sci. Tech. art. no. 7 (2020); FAQS About Cultivated Meat, Four Paws (May 23, 2023), https://www.four-paws.org/about-us/faqs-collection/faqs-about-cultivated-meat [https://perma.cc/PV5E-5MUX].
2 Laura Reiley, Cell-Cultured Chicken Gets the Final Green Light from USDA, Wash. Post (June 21, 2023), https://www.washingtonpost.com/business/2023/06/21/usda-cultivated-meat-approval/.
3 Elliot Swartz & Claire Bomkamp, The Science of Cultivated Meat, Good Food Inst., https://gfi.org/science/the-science-of-cultivated-meat/ [https://perma.cc/C8R3-LPM5] (last visited July 12, 2024).
4 Id.
5 Id.
6 Id.
7 Natalie R. Rubio, Ning Xiang & David L. Kaplan, Plant-Based and Cell-Based Approaches to Meat Production, 11 Nat. Comms. art. no. e6276, at 2 (2020), https://www.nature.com/articles/s41467-020-20061-y.
8 Id.
9 Hanna L. Tuomisto, The Eco-Friendly Burger: Could Cultured Meat Improve the Environmental Sustainability of Meat Products?, 20 EMBO Reps. e47395, at 3 (2018); Jennifer Penn, Comment, “Cultured Meat”: Lab-Grown Beef and Regulating the Future Meat Market, 36 UCLA J. Env’t L. & Pol’y 104, 107 (2018); Memorandum from Jeremiah Fasano to Administrative File, CCC 000002, at 5 (Nov. 14, 2022) [hereinafter UPSIDE Consultation], https://www.fda.gov/media/163261/download.
11 See Jude Whiley, Yes, Lab-Grown Meat Is Vegan, WIRED (Feb. 19, 2023), https://www.wired.com/story/lab-grown-meat-vegan-ethics-environment/ (“Though these biopsies are invasive, the process is less painful than many of the procedures an animal might endure during its lifetime on a farm, and, importantly, the process does not involve the animal being killed.”).
12 UPSIDE Consultation, supra note 9, at 6.
15 Tuomisto, supra note 9, at 3.
16 See UPSIDE Consultation, supra note 9, at 11–13.
17 See id. at 11–12.
18 Id. at 12.
19 See UPSIDE Consultation, supra note 9, at 9–10.
20 Scott J. Allan, Paul A. De Bank & Marianne J. Ellis, Bioprocess Design Considerations for Cultured Meat Production with a Focus on the Expansion Bioreactor, 3 Frontiers Sust. Food Sys. art. no. 44, at 2–7 (2019).
21 UPSIDE Consultation, supra note 9, at 9.
22 Lijing Jiang, Alexis Carrel’s Immortal Chick Heart Tissue Cultures (1912-1946), Ariz. State Univ. Embryo Project Encyc. (July 3, 2012), https://embryo.asu.edu/pages/alexis-carrels-immortal-chick-heart-tissue-cultures-1912-1946 [https://perma.cc/JK9D-7SNH].
23 Pavan Kumar et al., In-Vitro Meat: A Promising Solution for Sustainability of Meat Sector, 63 J. Animal Sci. & Tech. 693, 697 tbl.1 (2021).
24 Id.
25 Id.
26 Id. at 696–97.
27 Id.
28 Id. at 709.
29 Nils-Gerrit Wunsch, Number of Cultivated Meat Companies Worldwide from 2011 to 2022, Statista (Apr. 18, 2023), https://www.statista.com/statistics/1379536/number-of-cultured-meat-companies/.
30 Anshuman Daga, Singapore Approves Sale of Lab-Grown Meat in World First, Reuters (Dec. 1, 2020), https://www.reuters.com/article/eat-just-singapore-idINL4N2II0BV/.
31 Cultivating Fat Without Fetal Bovine Serum, Mosa Meat (Jan. 17, 2024), https://mosameat.com/blog/cultivating-fat-without-fetal-bovine-serum [https://perma.cc/Y6FZ-BWAQ].
32 GOOD Meat and UPSIDE Foods Approved to Sell Cultivated Chicken Following Landmark USDA Action, Good Food Inst. (Jun. 21, 2023), https://gfi.org/press/good-meat-and-upside-foods-approved-to-sell-cultivated-chicken-following-landmark-usda-action/ [https://perma.cc/J5XR-A28C].
33 Pelle Sinke et al., Ex-Ante Life Cycle Assessment of Commercial-Scale Cultivated Meat Production in 2030, 28 Int’l J. Life Cycle Assess. 234, 235 (2023).
34 Neus González et al., Meat Consumption: Which Are the Current Global Risks? A Review of Recent (2010-2020) Evidences, 137 Food Rsch. Int’l 109341 (2020).
35 Tuomisto, supra note 9, at 2.
36 Id. at 2, 4 fig.3.
37 Id. at 2–3.
38 Id. at 4 fig.3.
39 See K. Jayathilakan et al., Utilization of Byproducts and Waste Materials from Meat, Poultry and Fish Processing Industries: A Review, 49 J. Food Sci. Tech. 278 (2011).
40 Aditi Mankad et al., Ethical Eggs: Can Synthetic Biology Disrupt the Global Egg Production Industry?, 6 Frontiers Sust. Food Sys. art no. 915454 (2022).
41 See generally Robbin Marks, Nat. Res. Def. Council & The Clean Water Network, Cesspools of Shame: How Factory Farm Lagoons and Sprayfields Threaten Environmental and Public Health (2001).
42 Neil Stephens et al., Bringing Cultured Meat to Market: Technical, Socio-Political, and Regulatory Challenges in Cellular Agriculture, 78 Trends Food Sci. & Tech. 155, 158 (2018) (“When considering food waste, traditional carcass utilisation within the commercial meat industry is the single biggest problem in the context of waste management. Cultured meat provides a new opportunity, whereby the prime cut alone is produced for consumption or processing rather than the whole carcass.”); Danielle Nierenberg & Lee Recht, Cellular Agriculture May Bring Hope in Reducing Food Waste and Environmental Impact, Food Tank (Jan. 21, 2024), https://foodtank.com/news/2024/01/cellular-agriculture-may-bring-hope-in-reducing-food-waste-and-environmental-impact/ (quoting Dana Gunders, Executive Director of ReFED, as saying: “One key benefit of cultivated meat is that you only have to raise the part people want to eat, not the bones, skin, or other body parts. That essentially eliminates the ‘loss’ of needing eight pounds of feed to get just one pound of food.”); but see, e.g.,Adenise L. Woiciechowski et al., Waste Management in Cultivated Meat Production, in Cultivated Meat: Technologies, Commercialization and Challenges 267–68 (Carlos R. Soccol et al. eds., 2024) (discussing effluents generated by cultivated meat production); Gabrielle M. Meyers et al., Nutrient Recovery in Cultured Meat Systems: Impacts on Cost and Sustainability Metrics, 10 Frontiers Nutr. art. no. 1151801 (2023) (comparing waste nitrogen from spent media in cultivated meat production with waste nitrogen from traditional meat production).
43 Rachel Graham, A Reflection of New Harvest’s Achievements: Bringing Winston Churchill’s Prediction to Life, New Harvest (Jun. 27, 2014), https://new-harvest.org/winston-churchill-prediction/ [https://perma.cc/WZU4-SQAW].
44 See, e.g., Tanvir Rahman et al., Zoonotic Diseases: Etiology, Impact, and Control, 8 Microorganisms 1, 2–4 tbl. 1 (2020); Stuart Levin, Zoonoses, in Goldman’s Cecil Medicine 1964, 1965–67, tbls.1–6 (Lee Goldman & Andrew I. Schafer eds., 2012).
45 Kelley Lee, The Global Governance of Emerging Zoonotic Diseases: Challenges and Proposed Reforms 1, 1 (2023), https://www.cfr.org/report/global-governance-emerging-zoonotic-diseases [https://perma.cc/B6T4-YMEL].
46 Matthew N. Hayek, The Infectious Disease Trap of Animal Agriculture, 8 Sci. Advances art. no. eadd6681, at 1 (2022); Walter Leal Filho et al., Climate Change and Zoonoses: A Review of Concepts, Definitions, and Bibliometrics, 19 Int’l J. Environ. Rsch. & Pub. Health art no. e893, at 6, 16–17 (2022).
47 Alyssa Marchese & Alice Hovorka, Zoonoses Transfer, Factory Farms and Unsustainable Human–Animal Relations, 14 Sustainability art no. e12806, at 1 (2022).
48 Hayek, supra note 46, at 1.
49 Tae Kyung Hong et al., Current Issues and Technical Advances in Cultured Meat Production: A Review, 41 Food Sci. Animal Res. 355, 355 (2021).
50 See Jonny Anomaly et al., Flesh Without Blood: The Public Health Benefits of Lab-Grown Meat, 21 J. Bioethical Inquiry 167, 168 (2024).
51 Matthew I. Hutchings et al., Antibiotics: Past, Present, and Future, 51 Current Op. Microbio. 72, 72 (2019) (“In just over 100 years antibiotics have drastically changed modern medicine and extended the average human lifespan by 23 years.”).
52 C. Lee Ventola, The Antibiotic Resistance Crisis, 40 Pharmacy & Therapeutics 277, 277 (2015).
53 CDC, Antibiotic Resistance Threats in the United States, 2019, at ii, v (2019).
54 Nicoletta Lanese, Dangerous ‘Superbugs’ Are on the Rise. What Can Stop Them?, Sci. Am. (Oct. 13, 2023), https://www.scientificamerican.com/article/dangerous-superbugs-are-a-growing-threat-and-antibiotics-cant-stop-their-rise-what-can/.
55 Jennifer Abbasi, Infectious Disease Expert Sees Threat from Colistin-Resistant Superbug, 316 JAMA 806, 806 (2016).
56 Id. at 807.
57 Id. at 806–07.
58 Id. at 807.
59 Id.
60 Id. at 806.
61 David C. Nwobodo et al., Antibiotic Resistance: The Challenges and Some Emerging Strategies for Tackling a Global Menace, 36 J. Clinical Lab’y Analysis art. no. e24655, at 2 (2022).
62 Hilary D. Marston et al., Antimicrobial Resistance, 316 JAMA 1193, 1194 (2016).
63 EU Bans the Routine Use of Antibiotics in Farmed Animals, World Animal Prot. (Jan. 28, 2022), https://www.worldanimalprotection.org/latest/news/eu-bans-antibiotic-overuse-farmed-animals [https://perma.cc/TG97-BVAV].
64 Antimicrobial Resistance, FDA (Oct. 10, 2024) https://www.fda.gov/animal-veterinary/safety-health/antimicrobial-resistance.
65 Timeline of FDA Action on Antimicrobial Resistance, FDA, https://www.fda.gov/animal-veterinary/antimicrobial-resistance/timeline-fda-action-antimicrobial-resistance (last visited July 16, 2024).
66 Bridget M. Kuehn, FDA Aims to Curb Farm Use of Antibiotics, 307 JAMA 2244, 2244 (2012).
67 See generally The National Antimicrobial Resistance Monitoring System, FDA, https://www.fda.gov/animal-veterinary/antimicrobial-resistance/national-antimicrobial-resistance-monitoring-system (last visited July 16, 2024).
68 Jay P. Graham, John J. Boland & Ellen Silbergeld, Growth Promoting Antibiotics in Food Animal Production: An Economic Analysis, 122 Pub. Health Rep. 79, 80 (2007).
69 Marston et al., supra note 62, at 1194.
70 FDA, 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, Part III: Data on Medically Important Drugs tbl.6b (2022).
71 See id.
72 Marston et al., supra note 62, at 1194.
73 See Ctr. for Vet. Med., FDA, Guidance for Indus. No. 209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals 21 (“FDA believes that some indications for prevention use are necessary and judicious as long as such use includes professional veterinary involvement.”).
74 Sabrina Tavernise, F.D.A. Restricts Antibiotics Use for Livestock, N.Y. Times (Dec. 11, 2013), https://www.nytimes.com/2013/12/12/health/fda-to-phase-out-use-of-some-antibiotics-in-animals-raised-for-meat.html.
75 UPSIDE Consultation, supra note 9, at 13; Memorandum from Katie Overbey to Administrative File, CCC 000001, at 9 (Mar. 17, 2023) [hereinafter GOOD Meat Consultation], https://www.fda.gov/media/166348/download.
76 Antimicrobial Resistance, FDA, https://www.fda.gov/animal-veterinary/safety-health/antimicrobial-resistance (last visited July 16, 2024).
77 See 86 Fed. Reg. 31317 (June 11, 2021); Ctr. for Vet. Med., FDA, Guidance for Indus. No. 263, Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available Over-the-Counter 4 (2021), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-263-recommendations-sponsors-medically-important-antimicrobial-drugs-approved-use-animals.
78 See FDA Regulated Meats and Meat Products for Human Consumption, FDA (Oct. 4, 2023), https://www.fda.gov/food/meat-guidance-documents-regulatory-information/fda-regulated-meats-and-meat-products-human-consumption (USDA has jurisdiction over slaughter, inspection, and processing of conventional (“amenable”) meats including cattle, swine, sheep, and poultry, whereas FDA has jurisdiction over game (“non-amenable”) meats); What Does FDA Regulate?, FDA (Mar. 29, 2024), https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate (FDA regulation of livestock farming is primarily limited to animal feed and vaccines); Human Food Made with Cultured Animal Cells, supra note 1 (outlining how existing FDA regulatory authority extends to cultivated meat production).
79 See What is Cultivated Meat?, McKinsey & Co. (Sept. 2023), https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-is-cultivated-meat [https://perma.cc/UX75-HW89].
80 World Food Programme, The State of Food Security and Nutrition in the World (SOFI) Report – 2023, at 8 fig.1 (2023); World Food Programme, Global Operational Response Plan 2023: Update #9, at 9 (2023).
81 See sources cited supra note 80; U.N. Secretary-General, Population, Food Security, Nutrition and Sustainable Development, ¶ 36-37, U.N. Doc. E/CN.9/2021/2 (Apr. 19–23, 2021).
82 See Peter Alexander et al., Human Appropriation of Land for Food: The Role of Diet, 41 Glob. Env’t Change 88, 90 tbl.1 (2016).
83 Mike Berners-Lee et al., Current Global Food Production Is Sufficient to Meet Human Nutritional Needs in 2050 Provided There Is Radical Societal Adaptation, 6 Elementa Sci. Anthro. art. no. 52, at 1–3 (2018).
84 Alexander et al., supra note 82, at 91 (in 2011, there were 4484 megahectares (Mha) of agricultural land used for human food production, of which 871 Mha (19%) were cropland directly purposed for human consumption); id. at 93 fig.3b. (18% of global calorie supply in 2011 was derived from animal products).
85 Pelle Sinke & Ingrid Odegard, CE Delft, LCA of Cultivated Meat: Future Projections for Different Scenarios 31 tbl.6 (2021), https://gfieurope.org/wp-content/uploads/2022/04/CE_Delft_190107_LCA_of_cultivated_meat_Def.pdf.
86 Alexander et al., supra note 82, at 90 tbl.1.
87 Sinke & Odegard, supra note 85, at 31 tbl.6.
88 Hannah Ritchie, If the World Adopted a Plant-Based Diet, We Would Reduce Global Agricultural Land Use from 4 to 1 Billion Hectares, Our World in Data (Mar. 4, 2021), https://ourworldindata.org/land-use-diets [https://perma.cc/QL4S-2AWV].
89 Emily S. Cassidy et al., Redefining Agricultural Yields: From Tonnes to People Nourished per Hectare, 8 Env’t. Rsch. Letters art. no. e034015, at 1, 4 (2013).
90 Alexander et al., supra note 82, at 88.
91 Food Sec. Info. Network & Glob. Network Against Food Crises, 2023 Global Report on Food Crises: Mid-Year Update (2023).
92 See generally Jonathan Morris, “One Ought Not Have So Delicate a Nose”: CAFOS, Agricultural Nuisance, and the Rise of the Right to Farm, 47 Env’t L. 261, 274 (2017).
93 Awadhendra Sharan, In the City, Out of Place: Nuisance, Pollution, and Dwelling in Delhi, c. 1850-2000, at 70–116 (2014).
94 See Philip Lymbery, The Case for Lab-Grown Meat, TIME (Oct. 24, 2023, 7:00 AM), https://time.com/6327474/lab-grown-meat-defense-essay/ (discussing successful cultivation of meet in outer space and quoting Didier Toubia, chief executive of Aleph Farms, as saying: “We are proving that cultivated meat can be produced anytime, anywhere, in any condition.”).
95 WildBio, https://wildbio.org [https://perma.cc/SS9R-2JHS] (last visited July 20, 2024).
96 Slaughter Cattle Grades and Standards, USDA, https://www.ams.usda.gov/grades-standards/slaughter-cattle-grades-and-standards [https://perma.cc/2CMA-GBGA] (last visited July 20, 2024).
97 GOOD Meat FAQ, GOOD Meat, https://www.goodmeat.co/faq (last visited July 20, 2024) (choose “Our Process” and then select “How long does it take to produce cultivated chicken?”).
98 John Cumbers, This Record-Breaking Dutch Startup Just Made Cultivated Meat in 8 Days, Forbes (May 23, 2023, 11:00 AM), https://www.forbes.com/sites/johncumbers/2023/05/23/this-record-breaking-dutch-startup-just-made-cultivated-meat-in-8-days/.
99 See, e.g., Eric Schulze, UPSIDE Foods, Premarket Notice for Integral Tissue Cultured Poultry Meat 16–18 (2021), https://www.fda.gov/media/163262/download.
100 Chriki & Hocquette, supra note 1, at 2, 7.
101 See GOOD Meat, supra note 97 (choose “Nutrition Information” and then select “What is the nutritional composition of GOOD Meat?”).
102 Crafting The Future of Plant-Based Eating, Steakholder Foods, https://steakholderfoods.com/company/about [https://perma.cc/V34J-SPWR] (last visited July 21, 2024).
103 Rikako Murayama, Japanese Scientists Work Up an Appetite for Lab-Grown Wagyu Beef, Reuters (Oct. 8, 2021, 1:00 PM), https://www.reuters.com/lifestyle/science/japanese-scientists-work-up-an-appetite-lab-grown-wagyu-beef-2021-10-08/.
104 See generally FDA, New Era of Smarter Food Safety: FDA’s Blueprint for the Future (2020).
105 See e.g., Whiley, supra note 10.
106 See Sghaier Chriki et al., Is “Cultured Meat” a Viable Alternative to Slaughtering Animals and a Good Comprise Between Animal Welfare and Human Expectations?, 12 Animal Frontiers 35, 40 (2022).
107 See id. at 35.
108 Leading Shariah Scholars Rule Cultivated Meat Can Be Halal, GOOD Meat (Sept. 11, 2023), https://www.goodmeat.co/all-news/leading-shariah-scholars-rule-cultivated-meat-can-be-halal [https://perma.cc/2K8J-7YBU].
109 Luke Tress, In First, Leading Kosher Authority Orthodox Union Certifies Lab-Grown Meat, Times Israel (Sept. 6, 2023, 8:47 PM), https://www.timesofisrael.com/in-first-leading-kosher-authority-orthodox-union-certifies-lab-grown-meat/.
110 Charlotte Pointing, What Is Cultivated Meat? Could It Change the Future of Food?, VegNews (Jul. 13, 2023), https://vegnews.com/vegan-news/what-is-cultivated-meat.
111 Paul Chaney, Shifting Public Attitudes to Animal Welfare? New Research Explores the Views of Civil Society Campaigners, Wales Inst. of Soc. & Econ. Rsch & Data (Aug. 2, 2023), https://wiserd.ac.uk/blog/shifting-public-attitudes-to-animal-welfare-new-research-explores-the-views-of-civil-society-campaigners/ [https://perma.cc/WY6L-NE8V].
112 FDA Modernization Act 2.0, S. 5002, 117th Cong. (2022); see also Jason J. Han, FDA Modernization Act 2.0 Allows for Alternatives to Animal Testing, 47 Artificial Organs 449, 449 (2023).Top of FormBottom of Form
113 Few Adults Are Interested in Trying Lab-Grown Meat, AP-NORC (June 21, 2023), https://apnorc.org/projects/few-adults-are-interested-in-trying-lab-grown-meat/.
114 Jonel Aleccia & Laura Ungar, US Approves Chicken Made from Cultivated Cells, the Nation’s First ‘Lab-Grown’ Meat, AP News (June 21, 2023, 11:23 AM), https://apnews.com/article/cultivated-meat-lab-grown-cell-based-a88ab8e0241712b501aa191cdbf6b39a.
115 AP-NORC, supra note 113.
116 Food & Agric. Org. of the U.N. & World Health Org., Food Safety Aspects of Cell-Based Food 76–98 & tbls. 5–8 (2022), https://doi.org/10.4060/cc4855en.
117 Id. at 76.
118 Id. at 77–98.
119 See id.
121 Food & Agric. Org. of the U.N. & World Health Org., supra note 116, at 108.
122 GOOD Meat, supra note 97 (choose “Our Process” and then select “Does GOOD Meat cultivated chicken involve antibiotics or genetic modification?”).
123 World Pat. App. Pub. No. WO 2017/124100 to Nicholas Genovese et al. (filed Jan. 17, 2017).
124 Food & Agric. Org. of the U.N. & World Health Org., supra note 116, at 108–09.
125 UPSIDE Consultation, supra note 9, at 16; see also GOOD Meat Consultation, at 10.
126 Food & Agric. Org. of the U.N. & World Health Org., supra note 116, at 108.
128 Food & Agric. Org. of the U.N. & World Health Org., supra note 116, at 99–101.
129 Id. at 88.
130 Id. at 99–106.
131 Id. at 25 tbl.3.
133 See sources cited supra note 132.
134 E.g., Joe Fassler, Lab-Grown Meat Has a P.R. Problem, The Fern (Feb. 7, 2023), https://thefern.org/impact/cell-cultured-meat-poses-questions-about-cancer/.
135 Melissa Goldin, Animal Cells Used to Create Lab-Grown Meat Are Not Cancerous, Experts Say, AP News (June 30, 2023, 12:46 PM), https://apnews.com/article/fact-check-lab-meat-cancer-animal-cells-449786524119.
136 Tammi S. Etheridge, What’s the Beef? The FDA, USDA, and Cell-Cultured Meat, 78 Wash. & Lee L. Rev. 1729, 1741 (2022).
137 Nikita Voloshin et al., Practical Use of Immortalized Cells in Medicine: Current Advances and Future Perspectives, 24 Int’l J, Molecular Scis. art. no. 12716, at 1 (2023).
138 Goldin, supra note 135 (quoting Elliot Swartz, principal scientist at the Good Food Institute).
139 Kimberly J. Ong et al., Cultured Meat Safety Research Priorities: Regulatory and Governmental Perspectives, 12 Foods art. no. 2645, at 8, 11 (2023).
140 Food & Agric. Org. of the U.N. & World Health Org., supra note 116, at 110.
141 Press Release, Jay Pritzker, Governor, Illinois, Gov. Pritzker Announces UPSIDE Foods Will Open Its First Commercial-Scale Cultivated Meat Production Plant in Glenview (Sept. 14, 2023), https://www.illinois.gov/news/press-release.27020.html, [https://perma.cc/S4J3-JWGW].
142 USDA, Poultry – Production and Value 2022 Summary 7 (2023), https://downloads.usda.library.cornell.edu/usda-esmis/files/m039k491c/wm119387d/5138kw352/plva0423.pdf.
143 See generally, e.g., Derrick Risner et al., Environmental Impacts of Cultured Meat: A Cradle-to-Gate LifeCycle Assessment, ACS Food Sci. & Tech. (Special Issue in Alternative Protein Sources for Responsible Food Consumption and Production 2024); Sinke et al., supra note 34.
144 John Lynch & Raymond Pierrehumbert, Climate Impacts of Cultured Meat and Beef Cattle, 3 Sust. Food Sys. art. no. 5, at 5–8 (2019).
145 Risner et al., supra note 143, at I; Amy Quinton, Lab-Grown Meat’s Carbon Footprint Potentially Worse Than Retail Beef, UCDavis (May 22, 2023), https://www.ucdavis.edu/food/news/lab-grown-meat-carbon-footprint-worse-beef.
146 See Formal Agreement Between FDA and USDA, supra note 1.
147 Id.
148 Id.
149 Id.
150 Id.
151 See the General Biological Products Standards 21 C.F.R. Part 610 (2024), especially 21 C.F.R. § 610.10 (purity) and § 610.18 (cultures). See also Food Chemical Safety, FDA (Dec.23, 2024), https://www.fda.gov/food/food-ingredients-packaging/food-chemical-safety.
152 Formal Agreement Between FDA and USDA, supra note 1.
153 Id.
154 Inst. of Med., The Nat’l Acads., Ensuring Safe Food: From Production to Consumption 26–27 (1998). But see supra note 78 (discussing FDA jurisdiction over production of non-amenable meats).
155 Cf. Etheridge, supra note 136, at 1786 (“There is nothing that the USDA can do to help manage [the in-vitro growing] part of the process … . [T]he FDA is more than capable of inspecting these establishments and their products” in the final stage of the manufacturing process.).
156 See UPSIDE Consultation, supra note 9, at 9.
157 Formal Agreement Between FDA and USDA, supra note 1.
158 Id.
159 Id.
160 See id.
161 Id.
162 Id.
163 Federal Meat Inspection Act, 21 U.S.C. §§ 601–695.
164 Poultry Products Inspection Act, 21 U.S.C. §§ 451–473.
165 Egg Products Inspection Act, 21 U.S.C. § 1031.
166 Hazard Analysis and Critical Control Point (HACCP) Systems, 9 C.F.R. §§ 417.1–.8 (2024); see also Nat’l Advisory COMM. ON Microbiological Criteria For Foods, HACCP Principles & Application Guidelines FDA, FDA (adopted Aug. 14, 1997), https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines.
167 USDA Food & Safety Inspection Serv., FSIS Responsibilities in Establishments Producing Cell-Cultured Meat and Poultry Food Products 1 (2023), https://www.fsis.usda.gov/sites/default/files/media_file/documents/7800.1.pdf (“Cell-cultured meat and poultry food products are subject to the same FSIS regulatory requirements and oversight authority as meat and poultry food products derived from the slaughter of amenable species.”).
168 Etheridge, supra note 136, at 1756.
169 Id. at 1757.
170 See Formal Agreement Between FDA and USDA, supra note 1.
171 Etheridge, supra note 136, at 1758.
172 Id. at 1763.
173 Id. at 1764–65.
174 Id. at 1775.
175 Id. at 1756–67.
176 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(f).
177 See Substances Generally Recognized as Safe, 81 Fed. Reg. 54960, 54962–64 (Aug. 17, 2016).
178 Id. at 54965, 54982; see also Daniel G. Aaron, The Fall of FDA Review, 22 Yale J. Health Pol’y L. & Ethics 95, 153–58 (2023).
179 See discussion supra Section IV.A.
180 Etheridge, supra note 136, at 1796–97.
181 Id.
182 Inst. of Med., The Nat’l Acads., Challenges for the FDA: The Future of Drug Safety, Workshop Summary 2, 10, 15, 71 (2007).
183 U.S. Food and Drug Administration, FY 2024 Budget Summary, https://www.fda.gov/media/166050/download; U.S. Food and Drug Administration, FY 2025 Budget Summary, https://www.fda.gov/media/176923/download.
184 Dan Flynn, Food safety budgets are coming together, but not without some concerns, Food Safety News (July 15, 2024), https://www.foodsafetynews.com/2024/07/food-safety-budgets-are-coming-together-but-not-without-some-concerns/.
185 9 C.F.R. § 301.2 (2024).
186 Id.
187 See generally Penn, supra note 9.
188 See, e.g., Chriki et al., supra note 106, at 35–37 (reviewing discussion in the literature of whether cultured meat is “really meat”); id. at 41 (arguing that cultured meat should not be called “meat” until technology is “mature enough” to produce a product composed of diverse tissues that more closely resembles animal meat); see also, e.g., Mitch Perry, Florida Now Poised To Become the First State in the Nation To Ban Lab-Grown Meat, Fla. Phoenix (Mar. 6, 2024, 2:29 PM), https://floridaphoenix.com/2024/03/06/florida-now-poised-to-become-the-first-state-in-the-nation-to-ban-lab-grown-meat/ (quoting representative Dean Black of Jacksonville, Florida, as saying: “Cultured meat is not meat … [B]ecause really what it is a petri dish. It is simply a bacterial culture.”).
189 See infra Part VII.
190 Proposed Rule for Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology, RIN 0583–AD89, 89 Fed. Reg. 9310 (Feb. 9, 2024).
191 Etheridge, supra note 136, at 1790–93.
192 Id. at 1732–33.
193 Id. at 1775.
194 Mo. Rev. Stat. § 265.494 (2018); Missouri Meat Advertising Law, Mo. Dep’t of Agric. (Aug. 30, 2018), https://agriculture.mo.gov/animals/meat.php [https://perma.cc/9JKJ-6T85].
195 Cecilia Nowell, ‘Political efforts’: The Republican States Trying to Ban Lab-Grown Meat, Guardian (Apr. 9, 2024, 6:00 AM), https://www.theguardian.com/environment/2024/apr/09/us-states-republicans-banning-lab-grown-meat.
196 Turtle Island Foods, SPC v. Thompson, 725 F.Supp.3d 963 (W.D. Mo. 2024).
197 GOOD Meat, Dossier in Support of the Safety of GOOD Meat Cultured Chicken As a Human Food Ingredient 81 (2022), https://www.fda.gov/media/166346/download.
198 Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996).
199 See Turtle Island Foods, SPC v. Soman, 424 F. Supp. 3d 552 (E.D. Ark. 2019); Turtle Island Foods, SPC v. Soman, 632 F. Supp. 3d 909 (E.D. Ark. 2022).
200 Steph Tai, Legalizing the Meaning of Meat, 51 Loy. U. Chi. L.J. 743, 773 (2020).
201 Id. at 774–775.
202 Id. at 774 (citing Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of New York, 447 U.S. 557, 566 (1980)).
203 Florida Senate Bill 1084, 2024 Regular Session, Fla. Senate, https://www.flsenate.gov/Session/Bill/2024/1084 [https://perma.cc/P5BU-5D46] (last visited July 22, 2024); Fla. Stat. §§ 500.3, 500.452 (2024).
204 Alabama Senate Bill 23, 2024 Regular Session, LegiScan https://legiscan.com/AL/bill/SB23/2024 [https://perma.cc/3QPG-W6W6] (last visited July 22, 2024); Ala. Code § 20-1-8 (2024).
205 Colorado House Bill 25-1064, 75th Gen. Assemb., 1st Reg. Sess. (Colo. 2025), LEGISCAN https://legiscan.com/CO/bill/HB1064/2025 [https://perma.cc/B8QA-BDTK] (last visited February 4, 2024).
206 Illinois House Bill 5872, 103rd Gen. Assemb, 2025 Regular Session, (Ill. 2025), LEGISCAN https://legiscan.com/IL/bill/HB5872/2023.
207 Iowa Senate Bill 2391, 2024 Regular Session, LEGISCAN https://legiscan.com/IA/bill/SF2391/2023; IOWA CODE § 135.16C (2024).
208 Mississippi House Bill 1006, 2025 Reg. Sess. (Miss. 2025), LEGISCAN https://legiscan.com/MS/bill/HB1006/2025 [https://perma.cc/Q98G-69T4] (last visited January 21, 2025).
209 Missouri House Bill 808, 103rd Gen. Assemb., 1st Reg. Sess. (Mo. 2025), LEGISCAN https://legiscan.com/MO/bill/HB808/2025 [https://perma.cc/MZ8F-TFV6] (last visited January 14, 2025).
210 Nebraska Legislative Bill 246, 109th Leg., 1st Sess. (Neb. 2025), LEGISCAN https://legiscan.com/NE/bill/LB246/2025 [https://perma.cc/W9ND-9GTH] (last visited January 21, 2025).
211 North Dakota House Bill 1151, 69th Leg. Assemb. (N.D. 2025), LEGISCAN https://legiscan.com/ND/bill/HB1151/2025 [https://perma.cc/UU2G-AQP3] (last visited January 21, 2025).
212 Oklahoma Senate Bill 22, 60th Leg., 1st Sess. (Okla. 2025), LEGISCAN https://legiscan.com/OK/bill/SB22/2025 [https://perma.cc/XE4W-DVFZ] (last visited January 14, 2025).
213 South Dakota House Bill 1109, 2025 Leg. Sess. (S.D. 2025), LEGISCAN https://legiscan.com/SD/bill/HB1109/2025 [https://sdlegislature.gov/Session/Bill/25438/280332].
214 Texas Senate Bill 261, Leg., R.S. (Tex. 2025), LEGISCAN https://legiscan.com/TX/bill/SB261/2025 [https://perma.cc/D4VB-X6W9] (last visited January 21, 2025).
215 Larissa Zimberoff, California Just Invested Millions in Lab-Grown Meat, Becoming the First State to Back the Unproven Industry, S.F. Chron. (July 22, 2022, 7:22 AM), https://www.sfchronicle.com/food/article/California-lab-grown-meat-17318619.php.
216 Id.
217 Jacob Ogles, Senate Committee Advances Total Ban on Cultivated Meat, Fla. Pol. (Feb. 8, 2024), https://floridapolitics.com/archives/658259-senate-committee-advances-total-ban-on-cultivated-meat/ [https://perma.cc/Y2RN-VDDF].
218 Id.
219 Katherine Tangalakis-Lippert, The GOP’s Got a Growing Beef with Lab-Made Meat, Bus. Insider (Apr. 21, 2024, 5:17 PM), https://www.businessinsider.com/politicians-dragging-lab-grown-cultured-meat-into-culture-wars-2024-4; Thai, supra note 198, at 752 (describing meat labeling laws as a “battle for … what meat ‘represents’ to us in our diets”); Paul Krugman, What MAGA’s Beef with Lab-Grown Meat Says About the G.O.P (May 15, 2024), https://www.nytimes.com/2024/05/15/opinion/lab-meat-maga-florida.html.
220 Perry, supra note 188.
221 Id.
222 Tangalakis-Lippert, supra note 219.
223 Bruce Ritchie, The Steaks Are High: Florida Republican Wants to Ban Lab-Grown Meat, Politico (Nov. 15, 2023, 6:25 PM), https://www.politico.com/news/2023/11/15/florida-republican-lab-grown-meat-ban-00127447.
224 See Climate-Related Disclosures/ESG Investing, SEC (archived June 28, 2024) [https://web.archive.org/web/20240628110716/https://www.sec.gov/securities-topics/climate-esg].
225 An Act Relating to the Sale of Meat, H.B. 2121, 56th Leg., 2d Reg. Sess. (Ariz. 2024), https://www.azleg.gov/legtext/56leg/2R/bills/HB2121H.pdf.
226 See, e.g., The Big Names Investing in Cultivated Meat, Believer (Mar. 29, 2023), https://www.believermeats.com/blog/investing-in-cultivated-meat [https://perma.cc/NR86-NTND].
227 Id.
228 UPSIDE Is Approved for Sale in the US! Here’s What You Need to Know, UPSIDE Foods (June 21, 2023), https://upsidefoods.com/blog/upside-is-approved-for-sale-in-the-us-heres-what-you-need-to-know [https://perma.cc/VFP2-6BT4].
229 Samuel Gregory-Manning, Mark Post: ‘The Future of Lab-Grown Meat Is Promising,’ Eur. Sci.-Media Hub (Feb. 21, 2024), https://sciencemediahub.eu/2024/02/21/mark-post-the-future-of-lab-grown-meat-is-promising/ [https://perma.cc/P9KM-WPWB].
230 Rodrigo Luiz Morais-da-Silva et al., The Expected Impact of Cultivated and Plant-Based Meats on Jobs: The Views of Experts from Brazil, the United States and Europe, 9 Humans. & Soc. Sci. Commc’ns art. no. e297, at 2, 12 (2022).
231 See Good Food Inst., supra note 33.
233 See Current Good Manufacturing Practice, 21 C.F.R. §§ 117.10–.110 (2024).
235 See GOOD Meat Consultation, supra note 75, at 12 (“The primary focus of FDA’s evaluation is the information on which the firm relies to conclude that the harvested cell material is safe for use as food and does not contain substances or microorganisms that would adulterate the food”); see also generally id.; UPSIDE Consultation, supra note 9; 21 C.F.R. § 117.80 (Processes and Controls).
238 Id.
239 GOOD Meat Consultation, supra note 75, at 17–20; UPSIDE Consultation, at 12–15.
240 GOOD Meat Consultation, supra note 75, at 9, 13–14, 17; UPSIDE Consultation, at 11–12, 17–19.
241 See Krissa Welshans, Companies Approved to Sell Lab-Grown Chicken in the U.S., Feedstuffs (June 22, 2023), https://www.feedstuffs.com/agribusiness-news/companies-approved-to-sell-lab-grown-chicken-in-the-u-s- (UPSIDE began “working diligently” with FDA and USDA in 2018 after the formal joint regulatory agreement).
242 Human Food Made with Cultured Animal Cells, supra note 1.
243 Matt Reynolds, Insiders Reveal Major Problems at Lab-Grown Meat Startup Upside Foods, WIRED (Sept. 15, 2023), https://www.wired.com/story/upside-foods-lab-grown-chicken/ (citing setbacks and regulatory obstacles that may limit the technology from becoming commercially viable).
244 GOOD Meat Gets Full Approval in the U.S. for Cultivated Meat, GOOD Meat (June 21, 2023), https://www.goodmeat.co/all-news/good-meat-gets-full-approval-in-the-us-for-cultivated-meat [https://perma.cc/6GJR-DQYT].
245 Reshaping the Future of Food Production: UPSIDE Foods Announces Cultivated Meat Production Plant in Chicagoland, UPSIDE Foods (Sept. 14, 2023), https://upsidefoods.com/blog/reshaping-the-future-of-food-production-upside-foods-announces-cultivated-meat-production-plant-in-chicagoland [https://perma.cc/YQP5-8759].
246 See discussion supra Section V.B.3.
247 See supra text accompanying note 197.
248 Formal Agreement Between FDA and USDA, supra note 1.
250 Formal Agreement Between FDA and USDA, supra note 1.
251 See id.
252 Bernice Young et al., America’s Food Safety System Failed to Stop a Salmonella Epidemic. It’s Still Making People Sick, ProPublica (Oct. 29, 2021, 8:00 AM), https://www.propublica.org/article/salmonella-chicken-usda-food-safety [https://perma.cc/3ZF5-HKWY]; Eric Katz, Federal Pork Inspectors Are Sounding the Alarm Over USDA’s Plan to Give Industry More Control, Gov’t Exec. (Mar. 6, 2020), https://www.govexec.com/management/2020/03/federal-pork-inspectors-are-sounding-alarm-over-usdas-plan-give-industry-more-control/163527/ [https://perma.cc/U9Q8-DV9D]; Rachel Fobar, USDA Accused of Ignoring Animal Welfare Violations in Favor of Business Interests, Nat’l Geo. (Oct. 13, 2021), https://www.nationalgeographic.com/animals/article/usda-accused-of-ignoring-animal-welfare-for-business-interests [https://perma.cc/QW3F-76G7].
253 See, e,g., Laboratory Sampling Program for Imported Meat, Poultry, and Egg Products - Revision 1, USDA (Oct. 4, 2024), https://www.fsis.usda.gov/policy/fsis-directives/9900.6 [https://perma.cc/59AP-9JR2].
254 See Etheridge, supra note 136.
255 See Ermie Mariano Jr. et al., The Color-Developing Methods for Cultivated Meat and Meat Analogues: A Mini-Review, 44 Food Sci. Animal Res. 356 (2024).
256 See, e.g., Cultivating Fat without Fetal Bovine Serum, Mosa Meat (Jan. 17, 2024), https://mosameat.com/blog/cultivating-fat-without-fetal-bovine-serum.
257 Compare Etheridge, supra note 136, at 1740, with discussion supra Section II.B.2.b.
258 Who Are We?, JOINN Biologics, https://www.joinnbio.com/about-us/ [https://perma.cc/5EA2-2RMP] (last visited July 23, 2024).
259 See UPSIDE Consultation, supra note 9, at 9.
260 See Reynolds, supra note 243 (Describing “an approach that is expensive and requires many hours of labor to produce even a small amount of meat.”).
261 See discussion supra Section V.B.3.
262 Accredited Third-Party Certification System, USDA, https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program (last visited Nov. 4, 2024).
263 See supra text accompanying note 182.
264 Federal Meat Inspection Act, Pub. L. No. 59-382, 34 Stat. 669, 674 (1906) (codified as amended at 21 U.S.C. § 608).
265 Etheridge, supra note 136, at 1778.
266 Id. at 1789.
267 See Abigail Schneider, Benjamin Kelly & Michael S. Sinha, Food Inspections: Searching for Contamination (and Solutions) In a Haystack, 21 J. Food L. & Pol’y (forthcoming 2025), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5122039.
268 Id. at 15.
269 FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011).
270 FDA’s Fast Track, Accelerated Approval, and Breakthrough Therapy designations all enable a company to engage in early meetings with FDA to discuss clinical trial development. See generally U.S. Food & Drug Admin., Expedited Programs for Serious Conditions – Drugs and Biologics: Guidance for Industry (2014); Id. at 9 (e.g., The Fast Track Designation includes “meetings with FDA, including pre-IND meetings, end-of-phase 1 meetings, and end-of-phase 2 meetings to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers.”).
271 Both GOOD Meat and UPSIDE Foods emphasize transparency on their respective websites. See GOOD Meat, Inc., https://goodmeatproject.org/ [https://perma.cc/KX64-U97C] (Transparency is listed as one of its 5 core values: “We insist that people have easy access to clear and accurate information about the meat they are buying.”); see also UPSIDE Foods, Meat Reimagined: No Harm, No Fowl (Sept. 24, 2024), https://upsidefoods.com/blog/meat-reimagined-no-farm-no-fowl [https://perma.cc/J2G6-FNYH] (“we’re participating in a pivotal shift towards a more ethical, sustainable, and transparent food system.”).
272 See supra Section VI.A.1.