Cultivated Meat Is Pulling Food Scientists Into a Two-Agency Regulatory System

Introduction

Cultivated meat — meat grown directly from animal cells in a bioreactor rather than raised and slaughtered — moved from pilot projects to commercial sale in the United States starting in 2023, when the first cultivated chicken products cleared the regulatory process and reached restaurant menus. The science gets most of the attention, but the regulatory path these products take is just as novel, and it's creating a small, specific hiring niche for people who can work fluently across two federal agencies that don't normally share jurisdiction over the same product.

That dual-agency structure, more than any single technical hurdle, is what makes regulatory affairs work in this space distinct from a typical food or biologics role, and it's worth understanding both for people already in food or agricultural regulatory careers and for anyone curious about where this corner of the industry is headed.

Two Agencies, One Product

Conventional meat production is regulated almost entirely by the US Department of Agriculture's Food Safety and Inspection Service, or FSIS, which inspects slaughter and processing facilities and approves labels before products reach consumers. The FDA's role in conventional meat is minimal. Cultivated meat breaks that pattern because the process starts with something FDA has long-standing authority over: a cell line, grown and multiplied in a controlled bioprocess that looks more like biologics manufacturing than animal agriculture.

In 2019, FDA and USDA issued a formal interagency agreement establishing how they would split oversight of cultivated meat and poultry products. FDA oversees the cell collection, cell banks, and the growth and differentiation process up through harvest, essentially treating the early production stages the way it would evaluate the safety of a novel food production method. USDA-FSIS then takes over at the point of harvest, overseeing the processing facility itself, conducting inspections comparable to those at a conventional slaughterhouse, and approving product labels before anything can be sold.

What FDA's Pre-Market Consultation Actually Reviews

Before a company can move a cultivated meat product toward market, it goes through a pre-market consultation with FDA, which is a voluntary but effectively mandatory process given that no company has tried to skip it and reach market successfully. The company submits a dossier describing the cell line's origin and identity, how it's grown, what materials and media are used in the bioreactor, and safety data addressing whether the production process introduces any hazard that wouldn't exist in conventionally raised meat. FDA reviews this and, if satisfied, issues a letter stating it has no further questions, which isn't a formal approval in the way a drug approval works but functions as the green light the industry needs before moving to the next stage.

This is where regulatory affairs professionals with a biologics or cell therapy background often find their skills transfer directly: cell line characterization, process validation, and media and raw material qualification are all concepts that map closely onto work done in biopharmaceutical manufacturing, just applied to a food product instead of a therapeutic.

Where USDA-FSIS Picks Up

Once FDA has completed its consultation, the company needs a facility that holds a grant of inspection from USDA-FSIS, meaning FSIS inspectors are present during production the way they would be at a conventional poultry or meat plant. FSIS also has to approve the product's label, including how the product is named and described to consumers, which has been a genuinely contested area: regulators and industry groups have debated terms like "cultivated," "cell-cultured," and "lab-grown," with conventional meat and poultry trade groups pushing for labeling rules that clearly distinguish these products from traditionally raised meat.

For regulatory affairs professionals, this stage requires a different skill set than the FDA consultation: familiarity with FSIS inspection expectations, food labeling regulations under the Federal Meat Inspection Act and Poultry Products Inspection Act, and the kind of claims substantiation work that's closer to conventional food regulatory affairs than to biologics.

The State-Level Pushback

Federal clearance hasn't settled the matter at the state level. Several states, including Florida and Alabama, have passed laws banning the manufacture or sale of cultivated meat products within their borders, arguing the products need more scrutiny or that they compete unfairly with traditional agriculture. Other states have introduced similar bills without passing them, and the legal questions these bans raise — including whether a state can override a product that has cleared federal food safety review — are still being litigated in some cases.

For regulatory affairs teams, this adds a state-by-state compliance layer that doesn't exist for most conventional food products sold nationally, and tracking which states restrict sale, and how aggressively those restrictions are enforced, has become a real part of the job for companies trying to plan distribution.

What This Means for Regulatory Affairs Hiring

The companies working in this space are still small in number and the roles are correspondingly few, but the skill combination they're hiring for is specific enough that it's worth naming directly. They want people who can read and write to both FDA's novel-food and biologics-adjacent expectations and USDA-FSIS's facility inspection and labeling framework, often within the same product launch timeline. That combination is uncommon enough that companies have drawn talent from several different starting points: biologics and cell therapy regulatory affairs professionals moving over for the production-process expertise, conventional food and meat regulatory specialists moving over for the FSIS and labeling expertise, and in some cases FDA or USDA alumni who understand how the interagency agreement actually works in practice from having been on the inside of it.

How the Approvals Have Actually Gone So Far

The first companies to clear this process, in 2023, were working through it for the first time alongside the agencies themselves, since neither FDA nor USDA had a template from a prior company to follow. That first-mover position meant unusually close, iterative engagement with agency reviewers, more akin to the back-and-forth of an early clinical development program than a routine food filing. Companies that have gone through the process since have benefited from more established expectations on both sides, but the process is still far from a checklist exercise. Each submission still requires agency reviewers to evaluate a production method that may differ meaningfully from the last one they saw, whether that's a different cell line, a different growth medium formulation, or a different bioreactor scale-up approach.

That means regulatory affairs professionals in this space spend a disproportionate amount of time in direct, substantive dialogue with agency staff compared to more established food categories, where companies can often rely on established guidance documents and precedent to predict what a reviewer will ask for. Strong technical writing and the ability to anticipate and preempt agency questions before they're asked are proportionally more valuable here than they are in categories where the regulatory path is well worn.

Skills That Translate, and the Gaps That Don't

If you're weighing whether to pursue this niche, the honest assessment is that your existing regulatory background will cover roughly half of what the job needs, and you'll need to build the other half. A biologics regulatory affairs professional moving into this space will recognize cell banking, process characterization, and raw material qualification immediately, but will likely need to learn FSIS inspection culture and meat and poultry labeling rules essentially from scratch. A conventional food regulatory affairs professional will have the opposite experience: FSIS and labeling will feel familiar, but bioprocess and cell line documentation will be new territory.

Because the field is still small, companies in this space tend to value people who are explicit about which half they're starting from and genuinely curious about closing the gap, over people who claim fluency in both from the outset. Given how specific and still-evolving the interagency framework is, a demonstrated ability to read primary regulatory guidance carefully and ask good clarifying questions of agency contacts tends to matter more here than it does in more established regulatory categories.

There's also a practical entry point worth naming: the 2019 interagency agreement and the agencies' own public statements about cultivated meat oversight are both available to read directly, and working through them carefully, alongside the public FDA consultation letters and USDA label approvals that have already been issued, is a reasonable way to build real familiarity with this framework before ever applying for a role in it. Few applicants to this niche have done that homework, which makes it a genuine differentiator in a field where formal experience is, by definition, hard to come by.

Conclusion

Cultivated meat is a small niche today, constrained by both the limited number of companies in the space and an unsettled state-level legal landscape, but the two-agency regulatory structure it operates under is a genuinely distinct skill set, not just a smaller version of conventional food or biologics regulatory affairs. For regulatory affairs professionals willing to learn the half of the framework they don't already know, it's one of the more interesting places in food and agricultural regulation to build expertise right now, precisely because so few people have had to build it yet.