FDA/USDA cultivated meat regulatory framework
Law & Regulation
In Effect
June 21, 2023
Summary
On 21 June 2023, the US Department of Agriculture completed the final regulatory approvals enabling the first commercial sales of cultivated meat in the United States, granting Grants of Inspection and Label Approvals to UPSIDE Foods and GOOD Meat (a division of Eat Just, Inc.) for their cultivated chicken products. These approvals completed a regulatory sequence established by a 2019 formal agreement between USDA’s Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA), which allocated joint oversight of human food produced using animal cell culture technology from livestock and poultry species under the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA). Under the framework, FDA oversees cell collection, cell banks, and cell growth and differentiation stages; FSIS assumes oversight at the cell harvest stage through processing, inspection, and labelling. In June–July 2023, FSIS issued implementing directives (FSIS Directives 7800.1 and 5730.1 and Notice 31-23) establishing inspection, sampling, and establishment responsibilities for cell-cultured meat and poultry products. The FSIS labelling rule for such products (RIN 0583-AD89) remained under proposed rulemaking as of end-2023. The 2023 approvals marked the first time cultivated meat — meat produced from animal cells without conventional slaughter — was authorised for commercial sale in the US.
Background Context
Before 2023, no cultivated meat products were approved for commercial sale in the United States, and cultivated meat had no defined federal regulatory pathway. The foundational framework was established on 7 March 2019 when FSIS and FDA signed a formal agreement allocating shared oversight of human food from animal cell culture technology. Under the 2019 agreement, USDA-amenable species — cattle, sheep, swine, goats, poultry, and Siluriformes fish regulated under FMIA and PPIA — were assigned to FSIS oversight at and after the cell harvest stage. FDA had previously issued “no questions” conclusions on pre-market consultations from UPSIDE Foods and GOOD Meat, confirming it had no further questions regarding the companies’ safety conclusions. The first documented commercial sales of cultivated meat occurred in Singapore in December 2020 (GOOD Meat), establishing international precedent. In 2020-2021, FSIS initiated an Advance Notice of Proposed Rulemaking (ANPR) on labelling of meat and poultry products made using cell culture technology, generating public comment that indicated broad agreement that labelling should indicate production method. The 2023 US approvals are the first in the US; UPSIDE Foods made initial sales through Bar Crenn restaurant in San Francisco.
System Impact
Direction
Neutral / Administrative
Type
Alters Legal Basis
Significance
Moderate
On 21 June 2023, USDA completed approvals enabling commercial sale of cultivated chicken from UPSIDE Foods and GOOD Meat, the first such authorisations in the United States. FSIS issued Directives 7800.1 and 5730.1 and Notice 31-23 in June 2023, establishing responsibilities for inspection personnel in establishments producing cell-cultured meat and poultry products under FMIA and PPIA. Under the framework, products from USDA-amenable species must obtain FDA “no questions” conclusion, then USDA Label Approval and Grant of Inspection before commercial sale. Products not from USDA-amenable species remain under FDA oversight for both pre-market and market stages. The FSIS labelling rule (RIN 0583-AD89) remained in proposed rulemaking as of the Fall 2023 Unified Regulatory Agenda; existing FMIA/PPIA labelling and pre-approval requirements apply to cultivated meat products in the interim. UPSIDE Foods’ Engineering, Production and Innovation Center (EPIC) and GOOD Meat’s facility received Grants of Inspection, enabling small-scale commercial production. US Cattlemen’s Association publicly argued that terms such as “meat” and “beef” should be reserved for conventionally produced products, framing the labelling debate that the pending rulemaking is designed to resolve.
Anticipated Effects
If the FSIS labelling rule (RIN 0583-AD89) is finalised, standardised terminology and disclosure requirements for meat and poultry products made using animal cell culture technology would be established, clarifying how such products are represented to consumers and how they are differentiated from conventionally produced meat.
If additional companies complete FDA pre-market consultation and obtain USDA inspection and labelling approvals, the number of cultivated meat and poultry products in the US market would expand, potentially creating a larger alternative production channel alongside conventional livestock slaughter systems.
Whether commercial expansion of cultivated meat production reduces the number of animals in conventional livestock farming and slaughter systems — versus creating an additive market segment — depends on consumer substitution patterns, pricing dynamics, and production scale trajectories that are not established in available sources.
Significance Rationale
Assigned Neutral / Administrative (impact direction) because the 2023 framework and approvals establish a new regulated commercial channel for cultivated meat without documenting a measured contraction or expansion of conventional livestock exploitation. No documented change in conventional chicken, cattle, or pig numbers is attributable to the 2023 approvals; cultivated chicken products entered a nascent commercial market at minimal volume through initial restaurant launches only. Whether the cultivated meat regulatory framework will, over time, reduce conventional livestock exploitation by substituting for conventional meat production is not established in available sources and cannot be attributed to the 2023 approvals themselves.
Assigned Alters Legal Basis (impact type) because the primary mechanism is the establishment of the legal and procedural basis under which cultivated meat products from USDA-amenable species may enter US commerce — what previously lacked a defined regulatory pathway now has one. The 2023 FSIS directives and product approvals changed what is legally authorised: cultivated chicken became a permitted commercial product under FMIA/PPIA inspection.
Assigned Moderate significance because the framework enables an emerging production technology to enter regulated US commerce for the first time, establishing legal and procedural conditions for cultivated meat across the world’s largest meat market. The development does not measurably alter conventional livestock systems at national scale in 2023; its significance is structural within the emerging cultivated meat sector rather than operational within the conventional meat system.
Impact direction is Neutral / Administrative; the trajectory sentence is not applicable.
Key Actors
FDA (an agency of the Department of Health and Human Services) oversees cell collection, banking, and growth/differentiation stages and issued “no questions” conclusions for UPSIDE Foods and GOOD Meat. USDA FSIS issued FSIS Directives 7800.1 and 5730.1 and Notice 31-23, and granted Label Approvals and Grants of Inspection for UPSIDE Foods and GOOD Meat cultivated chicken products on 21 June 2023. UPSIDE Foods (California) and GOOD Meat/Eat Just, Inc. are the two companies that received 2023 commercial approvals. The US Cattlemen’s Association engaged in public comments opposing the use of conventional meat terminology for cell-cultured products. FSIS Regulations Development Staff, led by Director Melissa Hammar, managed the labelling rulemaking (RIN 0583-AD89).
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