Scholars discuss challenges and opportunities in lab-grown meat regulation.
In 2023, federal food regulators approved two companies to sell cultivated chicken in the United States—that is, chicken produced by growing chicken cells in a laboratory setting. Experts predict that the market for cultivated chicken and other cultivated meats will grow in the coming years, and some scholars worry about whether the current regulatory structures will be sufficient to ensure safe production and distribution of lab-grown meat products.
In a recent article, Joseph DaVault and Michael Sinha analyze challenges in current lab-grown meat regulation. They propose regulatory reforms that would streamline future regulation of cultivated meat by clarifying definitional terms, introducing standardized safety procedures, and reducing inefficiencies in the regulatory approval process.
The production of lab-grown meat begins when scientists extract small cell samples from animals and place them in sterile laboratory environments to promote cell growth, DaVault and Sinha explain. Once cells multiply, scientists add substances that promote differentiation into muscle, fat, and other tissue types found in traditional meat. Scientists then harvest the meat and prepare it for distribution using conventional food processing methods.
Although cultivated meat production helps decrease animal suffering and is associated with less environmental harm than conventional meat production is, DaVault and Sinha argue that adoption of cultivated meat still presents challenges. They are concerned with potential contamination during the production process, because failure to identify contaminants early in a production can ruin full batches of cultivated meat. These safety concerns contribute to consumer distrust in lab-grown meat, DaVault and Sinha emphasize.
To realize the benefits of lab-grown meat while avoiding the risks, DaVault and Sinha advocate a strong regulatory framework. They praise the shared approach between the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA), articulated in a 2019 agreement. Under the agreement, FDA oversees the early stages of lab-grown meat production, including animal cell sampling and cultivation. USDA oversight begins after harvesting, and such oversight includes checking products, inspecting facilities, and approving labels.
DaVault and Sinha characterize the FDA–USDA regulatory approach as well-reasoned, building on the agencies’ existing capabilities. They argue that granting sole oversight to FDA would place significant burdens on the agency in a meat production realm that USDA has more experience regulating. They also explain that a long history of collaboration between USDA and FDA on food regulation facilitates a cross-agency regulatory approach.
According to DaVault and Sinha, however, FDA and USDA face significant hurdles in overseeing the production and distribution of lab-grown meat. DaVault and Sinha warn that classification of the products will be a challenge, because cultivated meat does not fit within FDA’s definition of meat or other statutory definitions. They explain that establishing a definition for lab-grown meat is important—it will influence the extent and scope of regulatory oversight.
Labeling requirements present another regulatory challenge, DaVault and Sinha argue. They note that USDA released a proposed rule that would require clear labels on all lab-grown meat products to indicate cultivated sources. They emphasize that lax standards could confuse consumers, while strict ones may raise free speech issues and burden businesses.
DaVault and Sinha are also concerned with politicization as a barrier to effective regulation. Although federal regulators have approved the sale of cultivated meat, some states have passed bills restricting or banning it. The authors attribute these bans to consumer safety concerns and lobbying efforts by traditional meat producers.
DaVault and Sinha introduce policy recommendations to address these regulatory challenges.
They contend that FDA, USDA, and other regulatory authorities should develop a streamlined definition for cultivated meat. They propose a definition of cultivated meat that builds on the one that FDA and USDA outlined in their formal agreement: “animal-originated tissue products that have been grown or cultured from animal cells in a controlled environment, outside of the traditional animal husbandry context, for the purpose of food or food products for human consumption.”
A uniform, yet specific definition would promote greater regulatory consistency as lab-grown meat technologies develop, DaVault and Sinha emphasize. They argue that a shared definition would also reduce confusion among consumers about the differences between cultivated and plant-based meat.
DaVault and Sinha argue that FDA and USDA should also establish a strict regulatory framework for all cultivated meat facilities that is modeled on FDA’s existing regulation of biopharmaceutical producers. They recommend that the regulatory scheme includes contamination control and testing procedures at each stage of production, strict monitoring of laboratory and packaging environments, and standardized harvesting and washing techniques. DaVault and Sinha suggest that FDA and USDA should ensure cultivated meat producers are using proper sanitation and safety training procedures for workers.
Finally, DaVault and Sinha recommend that regulators create a more streamlined federal approval process for lab-grown meat producers. They suggest that FDA and USDA engage third parties to perform inspections of safety procedures, which would reduce costs associated with agency-executed inspections. DaVault and Sinha also urge regulators to adopt standardized documentation templates and pre-approval consultations. And they propose that FDA and USDA integrate digital platforms to expedite inspections, including continuous monitoring of contaminants released during the production process.
DaVault and Sinha claim that these resources would help manufacturers better understand application requirements and reduce the costs to agencies associated with inspections, leading to faster approvals. They stress that faster, more predictable approvals would allow cultivated meat companies to bring products to market while maintaining consumer safety.
A comprehensive regulatory scheme that incorporates these suggestions, according to DeVault and Sinha, would ensure product safety, promote continuous improvement, and build consumer confidence in cultivated meat products.
