Lab-grown meat doesn’t get FDA approval in the way a new drug does. Instead, the Food and Drug Administration runs a voluntary pre-market safety consultation covering the cell lines, growth media, and manufacturing process, and when it has no remaining safety concerns it issues a “no questions” letter. That letter clears the biology side. Before the product can actually be sold, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has to grant the facility inspection and sign off on labels. Both agencies must independently give the green light, and even then, a handful of states ban the product outright.
The FDA’s Role: A Consultation, Not a Formal Approval
Under a March 2019 agreement between the FDA and USDA-FSIS, the FDA has jurisdiction over the earliest stages of cultivated meat production: collecting cells from an animal, establishing and maintaining cell banks, and growing and differentiating those cells in a bioreactor.1U.S. Department of Agriculture. USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry The agency inspects the facilities and processes involved during this period.
Before moving to processing, a company goes through the FDA’s pre-market consultation. It is technically voluntary, but no company has reached the market without completing it, and FSIS will not take over oversight of a product that hasn’t cleared FDA review. In that sense, the consultation functions as a de facto gate.
What the FDA Reviews
The consultation requires extensive data. The FDA evaluates the full production process, including how cell lines and cell banks were established, every component and input used in the growth media, and the manufacturing controls in place to keep the process consistent and safe.2U.S. Food and Drug Administration. Human Food Made with Cultured Animal Cells The core concern is whether the resulting material would be adulterated under the Federal Food, Drug, and Cosmetic Act.
Cultivated meat manufacturers must also comply with current good manufacturing practice regulations and implement risk-based preventive controls, the same food safety framework that applies to other human food facilities under FDA jurisdiction.
The “No Questions” Letter
When the FDA is satisfied with the data, it issues a “no questions” letter. This signals the agency accepts the company’s conclusion that its product is safe. It is not a formal product approval. It means the FDA has reviewed the biology, the inputs, and the manufacturing and has no outstanding safety concerns. The first two companies received these letters for cultivated chicken products in late 2022 and early 2023.2U.S. Food and Drug Administration. Human Food Made with Cultured Animal Cells
Where FDA Authority Ends and USDA Takes Over
The FDA’s jurisdiction runs up to the moment cells are harvested from the bioreactor. At harvest, the two agencies coordinate a handoff. The FDA provides FSIS with the information it needs to confirm the harvested material is eligible to become a meat or poultry product bearing a USDA mark of inspection.3U.S. Food and Drug Administration. Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology From that point on, FSIS runs inspection at facilities where the cultured cells are processed, packaged, and labeled, using the same standards it applies to conventional slaughterhouses and processing plants.
Which Products Need Both Agencies
The joint framework only applies to species that already fall under FSIS statutory authority: livestock (cattle, sheep, swine, goats, horses), poultry, and catfish. Cultivated chicken, beef, and pork move through both agencies.1U.S. Department of Agriculture. USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry
Cultivated seafood other than catfish, as well as game meat, stays entirely under FDA jurisdiction through the full production cycle.2U.S. Food and Drug Administration. Human Food Made with Cultured Animal Cells A company producing cultivated salmon or shrimp deals only with the FDA and does not need a USDA grant of inspection.
What Happens After FDA Clearance
An FDA “no questions” letter alone doesn’t put product on shelves. For a species under USDA jurisdiction, the company still needs a grant of inspection from FSIS before it can process, package, or sell the product. FSIS issued the first grants of inspection for cultivated meat facilities in June 2023.
HACCP and Ongoing Inspection
Cultivated meat facilities must meet the same operational standards as traditional processing plants. The centerpiece is a Hazard Analysis and Critical Control Points (HACCP) system, in which the facility identifies every point in its process where a food safety risk could arise and develops specific controls to prevent it.3U.S. Food and Drug Administration. Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology FSIS inspectors verify that the plan is being followed, conduct sanitation checks, and perform pathogen and residue testing.4Congressional Research Service. Regulation of Cell-Cultured Meat
FSIS inspectors must be present in cultivated meat establishments during each operating shift.4Congressional Research Service. Regulation of Cell-Cultured Meat They observe harvest and processing operations in real time, verify records, and confirm that any ingredients added after harvest are safe and suitable for use in meat or poultry products. If testing reveals a problem, the facility has to take corrective action, reassess its HACCP plan, and document the reassessment.5USDA Food Safety and Inspection Service. FSIS Notice 31-23 Updated Cell-Cultured Meat and Poultry Products
Label Preapproval
For species under USDA jurisdiction, FSIS must preapprove every product label before the product enters commerce. Cultivated meat labels cannot go through the generic approval pathway that conventional meat products often use, because there is no established consumer understanding of the terminology.6USDA Food Safety and Inspection Service. FSIS Guideline for Label Approval FSIS published an advance notice of proposed rulemaking in September 2021 seeking public comment on names and disclosures, and as of 2026 has not issued a final rule.7Federal Register. Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells In the meantime, approved products have used qualifying terms such as “cell-cultivated” alongside standard meat terms.
Federal Clearance Doesn’t Override State Law
Clearing both federal agencies does not mean a product can be sold in every state. A small number of states have banned the manufacture, sale, and distribution of cultivated meat within their borders. Those bans took effect in 2024, and violations can result in criminal misdemeanor charges and suspension of food safety permits. Additional states have introduced bills to ban or restrict these products, and others have focused only on labeling.
Several states have their own labeling rules requiring a prominent qualifying term such as “cell-cultivated” or “lab-grown” near any traditional meat term on the label. Some treat the absence of a qualifier as misbranding. Companies selling across state lines have to track these separately from the FSIS label review, because state language and enforcement vary.
Products That Have Cleared the Federal Pathway
As of early 2026, five cultivated meat products have cleared the joint FDA-USDA regulatory pathway, covering chicken, salmon, pork fat, and poultry products. Clearance has not translated into wide availability. Most launches have gone through limited restaurant partnerships rather than grocery retail, and at least one company that received federal approval shut down operations in late 2025. The regulatory pathway is functional, but a “no questions” letter and a grant of inspection are the beginning of what a company has to navigate, not the end.