Cultivated protein products are moving from concept to commercialization through defined regulatory approval pathways in the U.S. and several international markets, but the "rules of the road" are still evolving.

The authors are tracking these developments closely, helping clients navigate a landscape that is changing in real time. Major takeaways from recent regulations include:

• Federal regulators have implemented a joint oversight framework, clearing five cultivated protein products for entry into the U.S. market
• Several states have moved in the opposite direction, enacting restrictions on labeling or sale, some of which are already facing legal challenges
• International regulators are advancing approvals without a harmonized global standard
• As the patchwork of product regulations becomes more interconnected, regulatory strategy is becoming essential to commercial viability.

A Federal Framework Takes Shape

In the U.S., oversight of cultivated protein products is shared between the Food and Drug Administration (FDA) and the Department of Agriculture (USDA).¹ The FDA–USDA joint framework is now operational and has already cleared multiple products, establishing a defined—though still evolving—pathway to commercialization in the U.S.

FDA regulates the upstream production process, which includes everything from cell collection and banking to growth and differentiation. As production moves further down the line, USDA's Food Safety and Inspection Service (FSIS) takes the reins for meat and poultry products, overseeing harvesting, inspection, processing, packaging, and labeling under the Federal Meat Inspection Act and the Poultry Products Inspection Act.² Products outside those statutes—such as seafood—remain under FDA jurisdiction.

To date, five cultivated protein products have successfully completed the U.S. regulatory review process, demonstrating that the FDA–USDA joint framework is operational.³ Consumers can now sample certain cultivated products at select restaurants, marking a notable milestone in the transition of these products from laboratory to menu.

The Labeling Question

Few regulatory questions matter more to companies entering the cultivated protein market than what these products can be called—a deceptively simple question that regulators, industry participants, and commentators are still debating.

In September 2021, FSIS issued an Advance Notice of Proposed Rulemaking (ANPR) requesting input on how meat and poultry products made from cultured animal cells should be labeled.⁴ Stakeholders expressed a range of views on what terms should be used, whether the term "meat" is appropriate, and how clearly cultivated protein labels must distinguish themselves from conventional products.⁵ Final federal labeling rules, however, have yet to be issued.⁵

The Trump Administration has moved USDA's proposed rule on "Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology" to the agency's long-term action agenda.⁶ This placement suggests that this is not an immediate priority and that USDA is unlikely to advance the rule in the coming year.

In the meantime, stakeholders may wish to begin marketing cultivated protein products before FSIS finalizes this rulemaking. The ANPR states that stakeholders that market such products during this time must submit their labels to FSIS for pre-approval.⁶ These labels will not be eligible for generic approval. FSIS will verify that they "clearly differentiate cell-cultured product from slaughtered meat and poultry products." The ANPR also clarifies that any labels approved during this time may need to be revised to comply with future FSIS regulations.

Despite the absence of finalized federal labeling regulations, the current framework provides a workable path forward for companies entering the cultivated protein market. Although formal rulemaking may not be imminent, this interim approach allows stakeholders to begin marketing products while continuing to engage with regulators.

States Enter the Debate

At the state level, the regulatory environment is becoming increasingly complex. Recent legislative activity underscores a growing divergence in how states approach cultivated protein products, with several enacting total or temporary prohibitions. States like Mississippi, Montana, and Nebraska have enacted wholesale statutory prohibitions restricting the manufacture, sale, or distribution of cultivated protein products.⁷ Others, including Indiana, Texas, and South Dakota, have adopted temporary prohibitions or restrictions.⁸ Still others, like South Dakota, permit public purchase while restricting the use of state funding for research, production, promotion, sale, or distribution.⁹

Two cases—one in Florida and another in Texas—are currently testing these restrictions under the Dormant Commerce Clause and related constitutional theories.¹⁰ Just last month, the Eleventh Circuit ruled in Upside Foods, Inc. v. Simpson that total state bans on cultivated protein products are not preempted by the Poultry Product Inspection Act.¹¹ In Wild Type, Inc. v. Shuford, the plaintiffs' preemption arguments were similarly dismissed by the Western District of Texas and are now on appeal to the Fifth Circuit; however, their claims under the Dormant Commerce Clause survived and are progressing in the trial court.¹² As these cases progress through the legal system, they provide clarification of how much power states have to regulate the cultivated protein market.

A Global Patchwork Emerges

Regulatory developments outside of the U.S. tell a similar story: rapid innovation paired with uneven policy approaches.

Singapore has emerged as an early global leader, approving multiple cultivated protein products like cultivated quail,¹³ and positioning itself as one of the first jurisdictions where cultivated protein has moved from regulatory milestone to menu item.¹⁴

Meanwhile, the UK has launched a regulatory "sandbox" designed to help companies work through applicable requirements.¹⁵ In contrast, some countries—including Italy and Hungary—have pursued national bans.¹⁶

Taken together, these developments highlight a broader reality: the regulatory debates playing out in the U.S. are mirrored across the globe.

Strategic Implications for Industry

The cultivated protein sector is entering a transitional phase. Federal approval pathways in the U.S. are now functioning, but state-level restrictions and ongoing litigation continue to introduce geographic uncertainty. International regulatory approaches remain fragmented, with some jurisdictions encouraging innovation while others move toward prohibition.

For companies evaluating opportunities in this sector, regulatory strategy is quickly becoming as critical as technological capability. Early planning around regulatory pathways, labeling strategy, and distribution considerations may help companies position themselves effectively as the sector continues its transition from concept to commercialization.

References

1. U.S. Food and Drug Administration (FDA). Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species. Current as of March 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. 
2. Federal Meat Inspection Act, 21 U.S.C. §§ 601–695; Poultry Products Inspection Act, 21 U.S.C. §§ 451–472.
3. UPSIDE Foods cultured chicken cell material approved November 16, 2022; GOOD Meat cultured chicken cell material approved March 20, 2023; Mission Barns cultured pork fat cells approved March 7, 2025; Believer Meats cultured chicken cell material approved July 24, 2025; Wildtype Salmon cultured salmon cell material approved May 28, 2025. See: FDA. "Inventory of Completed Pre‑market Consultations for Human Food Made Using Cultured Animal Cells." Current as of March 7, 2025. https://www.fda.gov/food/human-food-made-cultured-animal-cells/inventory-completed-pre-market-consultations-human-food-made-cultured-animal-cells and FDA. "Human Food Made with Cultured Animal Cells Inventory." https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=AnimalCellCultureFoods. 
4. U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS). Labeling of Meat and Poultry Products Comprised of or Containing Cultured Animal Cells. September 3, 2021. https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules/labeling-meat-or-poultry-products. 
5. Poinski, M. "Tracking the comments on cell-based meat labeling." Food Dive. May 31, 2022. https://www.fooddive.com/news/cell-based-cultivated-meat-comments-tracker-usda/623608/. 
6. USDA-FSIS. Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology. September 3, 2021. https://www.federalregister.gov/documents/2021/09/03/2021-19057/labeling-of-meat-or-poultry-products-comprised-of-or-containing-cultured-animal-cells. 
7. H.B. 1006, 2025 Leg., Reg. Sess. (Miss. 2025); H.B. 401, 69th Leg., Reg. Sess. (Mont. 2025); L.B. 246, 109th Leg., Reg. Sess. (Neb. 2025).
8. H.B. 1425, Pub. L. No. 229, 124th Gen. Assemb., 1st Reg. Sess. (Ind. 2025); S.B. 261, 89th Leg., Reg. Sess. (Tex. 2025).
9. H.B. 1118, 100th Leg., Reg. Sess. (S.D. 2025).
10. Upside Foods, Inc. v. Simpson, No. 4:24‑cv‑00319 (N.D. Fla.); Wild Type, Inc. v. Shuford, No. 1:25‑cv‑01408 (W.D. Tex.).
11. Upside Foods, Inc. v. Simpson, No. 24-13640, slip op. (11th Cir. 2026) (ruling preemption does not apply "[b]ecause Florida's ban on lab-grown meat does not regulate Upside's ingredients, premises, facilities, or operations").
12. Wild Type, Inc. v. Shuford, No. 1:25-cv-01408, slip op. (W.D. Tex. 2026).
13. Tan, C. "Forging Ahead with Forged Parfait." Men's Folio. June 26, 2024. https://www.mens-folio.com/lifestyle/forging-ahead-with-forged-parfait/. 
14. Singapore Food Agency. Requirements for the Safety Assessment of Novel Foods and Novel Food Ingredients. Updated March 17, 2025. https://www.sfa.gov.sg/docs/default-source/regulatory-standards-frameworks-and-guidelines/requirements-for-the-safety-assessment-of-novel-foods-and-novel-food-ingredients_17032025.pdf.
15. UK Department for Science, Innovation, and Technology. Guidance: Engineering Biology Sandbox Fund. Updated November 18, 2025. https://www.gov.uk/government/publications/engineering-biology-sandbox-fund and UK Food Standards Agency. "FSA launches pioneering regulatory programme for cell-cultivated products." Updated March 10, 2025. https://www.food.gov.uk/news-alerts/news/fsa-launches-pioneering-regulatory-programme-for-cell-cultivated-products. 
16. "Legge 1 dicembre 2023." Gazzetta Ufficiale della Repubblica Italiana 172 (2023). Italy. https://www.gazzettaufficiale.it/eli/id/2023/12/01/23G00188/sg; and "T/11151: On the ban on the production and marketing of artificial meat." Hungary. https://www.parlament.hu/web/guest/napirend?p_p_id=hu_parlament_cms_pair_portlet_PairProxy_INSTANCE_9xd2Wc9jP4z8&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&p_auth=Lq2C0UMo&_hu_parlament_cms_pair_portlet_PairProxy_INSTANCE_9xd2Wc9jP4z8_pairAction=%2Finternet%2Fcwap%2Fogy_irom.irom_adat%3Fp_ckl%3D42%26p_izon%3D11151. 2022. (Prohibition on cell-cultivated protein products went into effect on November 28, 2025.)