Pathway to Market is Complicated for Cell-Cultivated Protein cover art

Pathway to Market is Complicated for Cell-Cultivated Protein

Pathway to Market is Complicated for Cell-Cultivated Protein

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 As global demand for meat grows, this episode of Duke University's Leading Voices in Food podcast examines cell-cultivated protein—real meat grown from animal cells—and the evolving U.S. policy landscape shaping its future. Host Norbert Wilson (Duke World Food Policy Center) speaks with postdoctoral researchers Kate Consavage Stanley (Duke/Bezos Center for Sustainable Proteins) and Katariina Koivusaari (NC State/Bezos Center) about their article in Trends in Food Science and Technology on U.S. regulatory and legislative activity. The conversation explains the joint FDA–USDA regulatory approach for cell-cultivated meat (FDA oversight through cell cultivation; USDA oversight from harvest through processing, packaging, and labeling) and FDA oversight for cell-cultivated seafood (except catfish). They discuss timelines companies report for approval (often two to three years), the lack of federal public guidance on naming and labeling so far, and how USDA label approvals are currently handled case by case (e.g., "cell-cultivated chicken" and "cell-cultivated pork"). The episode also covers state-level labeling laws and the likelihood of federal preemption if state requirements conflict with federal statutes, as well as a growing wave of state restrictions and bans—Florida and Alabama in 2024, followed by Indiana, Mississippi, Montana, Nebraska, and Texas in 2025—plus funding restrictions in South Dakota and Iowa. The guests explore implications for consumers, interstate commerce, innovation, investment, and U.S. leadership, noting ongoing lawsuits in Florida and Texas and continued legislative activity such as a proposed ban in Georgia. Interview Transcript Kate, let's begin with you. In the paper, you write about the regulatory frameworks that have been developed for cell-cultivated meat and seafood products in the US. To start, let's talk about what's unique about cell-cultivated products from a regulatory standpoint and how the US Department of Agriculture and US Food and Drug Administration have decided to handle cell-cultivated protein products. Kate - Yes, so as you mentioned in the introduction, Norbert, cell-cultivation is a new technology for use of the food supply. So, the US government had to adapt its existing legal frameworks for food safety regulation. As your listeners may already know seafood is regulated by the FDA, so it was within their scope to also regulate cell-cultivated seafood. The FDA therefore regulates all cell-cultivated seafood products with the exception of catfish. When it came to determining the regulatory approach for cell-cultivated products from livestock, poultry, and catfish, it was a bit more nuanced as the processes and components evolved fell under both USDA and FDA purview. In 2019, the FDA and USDA therefore agreed on a joint regulatory approach where the FDA regulates the early stages of the cell cultivation process, including when those cells are taken from the animal, grown in the bioreactor, and matured into specific cell types such as muscle or fat cells. At the point where those cells are ready to be harvested from the bioreactor to use in a food product, oversight transfers to USDA who oversees that harvesting process as well as food processing, packaging, and labeling. I know this joint regulatory approach may sound complicated, but it's important to note that USDA and FDA already coordinate oversight over other foods in the food supply. I'll give you an example that we all love pizza. A frozen cheese pizza is regulated by the FDA, whereas a frozen pizza with meat toppings like pepperoni is regulated by the USDA. It is therefore not unprecedented that FDA and USDA would agree to jointly regulate cell-cultivated products. And while the process is new, the products go through the same safety checks as other foods in the food supply. In the past few years, we've seen four cell-cultivated meat products go through the joint USDA-FDA regulatory process, meaning they can be sold in the US food supply. And one cell-cultivated seafood product has gone through the FDA regulatory process. Kate, thank you for sharing this. And I've used a pizza example in my class, and it is super complex this regulatory maze that we're talking about. It seems like there has been a lot of collaboration between these two agencies, and so that's important to hear. But it is also the case that it seems challenging for cell-cultivated protein companies to get through this process. Is this a fair assessment and would you elaborate? Kate - Yes, absolutely. We've heard from cell-cultivated companies that it can take two to three years to get through this process. And there certainly is a lot of back and forth between the companies and FDA and USDA. Great, thank you. Katariina, now let's turn to you. How do these regulations extend to labeling and what do we know about the federal government's approach to labeling the sale of cultivated products thus far? Katariina – So, ...
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