What's the Beef?

As cell-cultured or “lab-grown” meat comes closer to hitting grocery store shelves, federal and state regulators are racing to develop a comprehensive regulatory scheme for these products. “Cell-cultured” meat is the technical term for what most people know as “lab-grown” meat. Labeling standards present a central, yet somewhat divisive issue for regulators to resolve. One set of stakeholders, traditional meat producers, are pushing for strict labeling requirements—they want to reserve terms like “meat” for meat made from animals. Supporters of these labeling restrictions argue that consumers are likely to be deceived by words like “burger” on alternative proteins. Alternative protein producers oppose the restrictions, claiming consumers will recognize the difference between the products. Rather, they argue that consumers are more likely to be confused about how to cook and serve the product if alternative protein producers cannot use familiar terms like “sausage” or “burger.” Additionally, alternative protein producers allege that laws and regulations restricting the use of such terms violate producers’ First Amendment right to free speech.

In recent years, several states have passed legislation on cell-cultured meat labeling, in the absence of federal regulation. However, the federal government is in the process of establishing comprehensive national standards. In early 2019, the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) agreed that FDA would have jurisdiction over the culturing process while the product is manufactured. USDA would then assume authority once the product is harvested, which includes the power to regulate the food’s labeling. In September 2021, USDA published an Advanced Notice of Proposed Rulemaking to solicit public input on how cell-cultured meat products should be labeled.

This Labels Unwrapped issue brief examines the recent cell-cultured meat labeling controversy. First, the brief provides general background on the science of cell-cultured meat production, discusses consumer trends and motivations, and introduces key stakeholder perspectives. It then explains the roles of different regulatory bodies, such as state lawmakers, Congress, federal agencies, and courts. Finally, the brief explains some of the major policy issues surrounding cell-cultured meat, such as federal preemption and consumer protection. This issue brief is intended to give consumers a better understanding of how cell-cultured meat products will likely be labeled when they hit the shelves of local grocery stores.

In 2013, food critics in London tasted the world’s first lab-grown hamburger. Although the burger cost well over $300,000 and was not ready to be marketed to consumers, the moment was decades in the making. In 1931, Winston Churchill published a predictive article called Fifty Years Hence. He predicted society would eventually “escape the absurdity” of traditional animal husbandry and instead would grow animal parts “separately under a suitable medium.” In 2022, Churchill’s prediction may be coming to fruition: lab-grown meat, also known as in-vitro meat or cell-cultured meat, is gaining momentum worldwide.

Cell-cultured meat is grown from animal stem cells. Muscle stem cells, which create new muscle tissue when an animal is injured, are extracted from a living animal and placed onto a “scaffold” in a sterile culture. The cells feed off the culture and grow in the shape of the scaffold. The cells then differentiate and eventually form myotubes, or muscle fiber. Layers of myotubes form muscle, or meat.

Many proponents of cell-cultured meat cite environmental, human health, and animal welfare costs of industrial livestock agriculture as the main drivers behind the innovation. Cell-cultured meat proponents point out that producing meat through traditional raising methods and grazing animals requires far more land and water than it would in a lab or factory. Further, industrial animal agriculture, the primary animal production method in the US, generates pollution in the form of animal waste. Health-conscious consumers may appreciate that cell-cultured meat is produced without antibiotics and can be tailored to have a lower fat content. In addition, some animal welfare advocates argue that cell-cultured meat is far more humane than traditional animal agriculture because it reduces the number of animals that are confined, put in stressful environments, or slaughtered. It remains to be seen whether any of these benefits would be derived from the widespread adoption of cell-cultured meat, as technological substitutes often do not impact the market in a predictable manner.

Uncertainty remains regarding the environmental benefits of cell-cultured meat. One early study estimated that cell-cultured meat will contribute 78–96 percent less greenhouse gas emissions, use 7–45 percent less energy, and consume 82–96 percent less water than traditional animal agriculture. But a follow-up 2015 study predicted that although cell-cultured meat production will use much less land than traditional animal agriculture, it may require substantially more energy. Animals expend a lot of energy to build muscle, so growing meat without the animal may likewise require a large amount of energy. Contributing to the initial energy input, the process requires a sterile environment because the cells are not connected to a functioning immune system, as they would be within a living animal. For example, researchers predicted that cell-cultured meat production will require sterile disposable plastic equipment and additional heat or chemical inputs to sterilize other equipment.

A more recent study used climate modeling to compare the impacts of cell-culture production to contemporary beef production. The study concluded that contemporary beef production contributed significantly more methane than cell-cultured meat, but cell-cultured meat had a higher carbon footprint. Methane has a greater warming effect than carbon, but the warming effect of carbon lasts much longer than methane. Therefore, unless energy is decarbonized, cell-cultured meat may not be better for the climate than traditional beef production in the long term. The researchers did note that cell-cultured meat likely used significantly less land and (depending on production method) contributed less water pollution. Ultimately, according to the study, the impacts of current and increasing beef consumption are incompatible with climate goals, whether that beef is produced through industrial animal agriculture or in cell cultures.

Though the ultimate benefits or risks of a cell-cultured meat market are still speculative, some in the beef industry are concerned about the cell-cultured meat industry’s potential growth and have begun preparing for serious market competition. For example, the beef industry is already working to prevent meat analogues from being used on cell-cultured meat labels, arguing that they could deceive or confuse consumers. Producers of meat alternatives, on the other hand, reject the consumer confusion argument and instead claim that the First Amendment protects their labeling choices. While cell-cultured meat is not yet readily available to consumers, both producers and their potential competitors are anxious for a comprehensive regulatory scheme, with labeling concerns at the forefront.

Two groups of stakeholders are driving the debate on whether and how to regulate alternative protein labeling, like cell-cultured meat products. One set of stakeholders—in favor of regulation—includes farmers using traditional animal agriculture to raise animals, trade associations, meat companies, and governments where a significant number of constituents are employed in animal agriculture or meat production. These stakeholders feel wary about allowing cell-cultured meat to be labeled with terms like “meat,” citing consumer confusion and the potential economic effect on the meat industry. These stakeholders are proponents of laws that prohibit using terms traditionally associated with animal-based protein on plant-based or cell-cultured products.

On the other side of the debate, stakeholders in competing industries, like producers of plant-based proteins and cell-cultured meat, are arguing against restrictive labeling laws. These alternative protein producers are concerned about the ability to competitively market meat-alternative products without meat analogue terms and descriptors on labels. The producers insist that consumers will not confuse animal-based meat with meat alternatives. Alternative protein producers argue that by prohibiting terms familiar to consumers, like “burger” or “roast,” consumers are more confused and may not understand how to cook and serve the food. These alternative protein producers oppose labeling laws that would restrict the use of meat analogues.

The guiding legal principle of food label regulation is the prohibition of misbranding and deception, to ensure transparency and accuracy for consumers. This issue is particularly salient for cell-cultured meat. Fitting cell-cultured meat into the existing legal framework is difficult because meat is regulated to account for the risks that come with slaughtering live animals. Cell-cultured meat is substantially the same product as meat from a slaughtered animal, but cell-cultured meat poses new and different risks. One of the major legal challenges for regulating cell-cultured meat is developing a legal framework that can address the safety risks presented by both products, including how to accurately label each product.

The Federal Regulatory Framework
The Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) are the two primary federal agencies relevant to the labeling, marketing, and sale of cell-cultured products. Within USDA, the Food Safety Inspection Service (FSIS) regulates most meat and poultry products. FDA is responsible for regulating the remainder of food products. After some debate over regulatory responsibility, FDA and USDA announced in 2019 that they would share regulatory authority over cell-cultured products.

Federal authority for regulating food labels is primarily split between USDA and FDA. USDA, through the FSIS, is responsible for regulation and inspection of meat, poultry, and some egg products, under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), respectively. Most other foods fall under FDA’s authority. FDA is charged with ensuring food safety through the Federal Food, Drug, and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), and the Fair Packaging and Labeling Act (FPLA). Each agency is responsible for preventing misbranding and adulteration.

There is substantial regulatory overlap between the agencies. USDA-FSIS has exclusive jurisdiction over certain products and facilities, but FDA regulates several food ingredients that are used in the production of food which may also include meat, poultry, or egg ingredients. For instance, FDA regulates frozen cheese pizza, but FSIS regulates frozen pepperoni pizza depending on the percentage of meat.

Fitting lab-grown meat into this regulatory framework is a complex issue. USDA-FSIS is set up to regulate most meat products. The FMIA, which gives USDA-FSIS the authority to regulate meat, defines “meat food products” in relevant part as:

This definition complicates the question of which agency is responsible for cell-cultured meat regulation. Is cell-cultured meat a “meat food product” within the meaning of the definition above? The initial cells needed to grow the meat came from an animal, but not specifically the carcass of the animal, as the cells are harvested from living animals. Nevertheless, the end product of cell-cultured meat is molecularly identical to meat produced by an animal. It may make sense that the two products should be regulated by the same agency because they are nearly the same product.

At the same time, FDA has substantial regulatory authority over manufactured food products, as well as drugs, devices, and cosmetics. For example, FDA issues regulations and provides technical support for food manufacturers to ensure that production methods comply with food safety standards. Cell-cultured meat is manufactured in a lab using processes traditionally under FDA control. Accordingly, FDA may be better suited to ensure cell-cultured meat processes are safe.
Additionally, the technology needed to produce cell-cultured meat may rely on devices under FDA’s authority. In fact, FDA has regulated animal cell culturing technologies as “devices” since 1980. The FDCA, which grants FDA regulatory authority, defines “device” as:

FDA and USDA-FSIS Regulatory Agreement
In March 2019, FDA published the Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species. The agreement commits the agencies to developing a “more detailed joint framework or standard operating procedure to facilitate coordination of shared regulatory oversight related to the harvest of biological material.” The agreement delegates authority to oversee cell collection and differentiation to FDA, as well as the authority to ensure that facilities conducting these practices comply with FDA food safety requirements. For meat from animals under the FMIA and PPIA, FSIS will take over responsibility after the harvest of cells. Most fish, seafood, and game meat will stay under FDA jurisdiction. USDA-FSIS will be primarily responsible for the regulation of labels, ensuring the “safety and accurate labeling of human food products derived from the cultured cells of livestock and poultry subject to the FMIA and PPIA.” However, the agencies have agreed to “develop joint principles for product labeling and claims to ensure that products are labeled consistently and transparently.”

On September 3, 2021, USDA-FSIS published an advance notice of proposed rulemaking (ANPRM), a formal statement from the agency requesting public input. In the ANPRM, the agency requested public input on a potential labeling requirement for cell-cultured meat food products. USDA-FSIS is considering several issues, including whether to establish a standard of identity for cell-cultured meat foods or change the regulatory definition of “meat” to exclude cell-cultured products.

The ANPRM was issued partially in response to two petitions for rulemaking: one from the Harvard Animal Law & Policy Clinic and the other from The US Cattlemen’s Association. The Harvard petition requested that USDA-FSIS adopt a regulatory approach to cell-cultured meat products that respects First Amendment commercial speech protections. More specifically, the Harvard petition urged the agency to “not ban the use of common or usual meat and poultry terms or product names on cell-based meat products and … only require disclosures when necessary to protect consumers … from an increased food safety risk or material compositional difference.” The US Cattlemen’s petition requested that USDA-FSIS “limit the definition of beef to product from cattle born, raised, and harvested in the traditional manner, … rather than coming from alternative sources such as a synthetic product from plant, insects, or other non-animal components and any product grown in labs from animal cells.”

On September 16, 2021, USDA-FSIS responded to both petitions. The agency cited its ANPRM in response to the petitions, saying, the “petition[s] [are] a topic of discussion in the ANPRM. Comments submitted in response to the ANPRM will expand FSIS’ understanding of cell-based products and help inform future rulemaking to establish labeling requirements and will help inform FSIS’ approach to the issues [] raised in [the] petition[s].” While USDA-FSIS agreed to move forward on evaluating cell-cultured meat labeling, the agency denied the Cattlemen’s petition to add formal definitions for meat products to the FSIS Food Standards and Labeling Policy Book. Adding these definitions would “effectively prohibit the labels of products made using animal cell culture technology … from displaying the terms ‘meat’ or ‘beef.’” Further, the agency denied the Cattlemen’s petition to regulate food labeling for all other products mentioned in the petition, including plant-based products. The agency does not have authority over these foods and refers non-animal product labeling issues to FDA.

While there is currently no clear federal agency guidance on cell-cultured meat labeling, the ANPRM and responses to petition indicate that USDA-FSIS is considering rulemaking in the near future. In the meantime, how the agency will address cell-cultured products using terms like “beef” remains unclear.

State Labeling Laws
Several states have proactively addressed the issue of whether the term “meat” can be used on a cell-cultured meat product. Missouri was the first state to pass legislation on the issue. In 2018, the state amended its Meat Advertising Law of 1985 to specifically prohibit misrepresentation of meat-like products. The amended section prohibits “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.”

The law affects both plant-based meat alternatives and cell-cultured meat. In a 2018 memorandum, Missouri’s Department of Agriculture (MDA) acknowledged that the guidance may need to be revisited once cell-cultured meat is on the market. Cell-cultured meat, MDA said, will likely have a greater risk of misrepresentation than plant-based products because “they are expected to have more similarity to products derived from harvested production livestock or poultry.” Accordingly, the MDA stated that it would not prosecute producers where the food’s label contains a “prominent statement … that the product is ‘plant-based,’ ‘veggie,’ ‘lab-grown,’ ‘lab-created,’ or a comparable qualifier,” including “made from plants” or “grown in a lab.”

As of May 2022, at least 14 other states have followed Missouri’s lead by passing laws amending the statutory definition of “meat” to preclude cell-cultured products from using the term. There is some variation of applicability of the state laws. South Carolina’s 2019 law explicitly targets cell-cultured meat, prohibiting the product from being labeled as “meat.” This differs from the Missouri law, which affected plant-based alternatives as well. Washington State may take the most aggressive stance on cell-cultured meat. In January 2019, Representatives Matt Shea (R), Bob McCaslin (R), Brian Blake (D), and Bruce Chandler (R) introduced the Natural Meat Protection Act to the House. If passed, the act would prohibit the advertising and sale of cell-cultured products. Other states have embraced alternative protein development. Minnesota, for example, introduced a bill that would allocate two million dollars for “research and development projects to accelerate the scaleup and commercialization of industry-advancing plant-based food products.”

Conflicts arise where both the states and the federal government seek to regulate meat labeling. The federal government has well-established statutes and regulations for national uniform meat labeling, inspections, and safety. These laws often preempt state laws to ensure uniform food safety standards throughout the country. However, states have a long history of regulating consumer protection, including prosecuting false and misleading labeling. This tension results in two primary policy concerns: (1) do states have the authority to regulate cell-cultured meat; and (2) how should regulators, whether state or federal, prevent consumer confusion around cell-cultured meat labeling?

Federal Preemption
Federal preemption is a legislative tool that prevents individual states from regulating topics under exclusive federal control. Federal statutes may expressly preempt state laws dealing with inherently national issues or topics that require national uniformity, such as immigration, airline and flight regulation, and ocean fishing. USDA-FSIS and FDA have committed to developing national principles for consistent and transparent labeling. The federal government has exclusive jurisdiction over many aspects of meat production through the Federal Meat Inspection Act (FMIA). The FMIA contains a provision to explicitly preempt state labeling standards. The provision reads:

National Meat Association v. Harris is one of the most influential cases dealing with state meat regulations. The case addresses a California law enacted after an investigation revealed that slaughterhouse workers were attempting to move non-ambulatory cattle by “dragging, kicking, and electro-shocking [the] sick and disabled cows.” The California law imposed additional requirements to those in the FMIA, such as preventing slaughterhouses from purchasing non-ambulatory cattle, prohibiting slaughterhouses from selling meat from non-ambulatory cattle, and requiring slaughterhouses to immediately euthanize any non-ambulatory animals they receive.

In National Meat Association v. Harris, the Supreme Court upheld the FMIA’s preemption clause, interpreting the clause broadly. The court held that the FMIA preempted the state law because the FMIA’s preemption clause “change to ‘”sweeps widely … precluding States from imposing requirements that are ‘within the scope’ of the FMIA.” The court also reasoned that animal type (ambulatory or non-ambulatory) was within the scope of FMIA’s regulation. Accordingly, the court held that the California law imposed additional requirements on slaughterhouses that were within the scope of the FMIA, which is not permitted due to the broad preemption provision in the FMIA.

However, in the absence of existing comprehensive national standards, several states have proactively enacted meat-labeling standards. As discussed above, cell-culture facilities will be inspected by FDA, not USDA-FSIS under the FMIA. However, USDA-FSIS and FDA will collaborate on the regulation of this product. It is unclear whether a preemption challenge will stand, but one is almost certain to be brought. National Meat Association may indicate a court’s likelihood to rule in favor of federal authority in this arena.

Consumer Protection
State and federal lawmakers work to balance the interests of the consumer and producer. Industries often rely on governments to regulate certain aspects of the consumer market. In the case of cell-cultured meat, the United States Cattlemen’s Association is advocating for federal action, in the hopes that the federal government will enforce strict standards with regards to the term “meat” or meat analogues on labels.

However, alternative protein producers argue that any state or federal law prohibiting them from using meat analogues to describe their product is unconstitutional, and the labeling restrictions are just pretense to protect traditional animal-based meat producers. Alternative protein stakeholders are already in litigation against state labeling standards, claiming First Amendment violations. The American Civil Liberties Union (ACLU), alongside Tofurky, the Good Food Institute, and the Animal Legal Defense Fund, have brought suit against Arkansas over Act 501, which prevents plant- or cell-based meat alternatives from bearing names like “meat,” “roast,” or “sausage.”

Following the Missouri amendment discussed above, which prohibits food producers from “misrepresenting a product as meat that is not derived from harvested production livestock or poultry,” the Good Food Institute and Tofurky sued the state seeking a preliminary injunction—a court order that temporarily prevents the state from enforcing the new labeling restrictions while the case is being argued. The plaintiffs, led by the Missouri ACLU, allege that the statute violates plaintiff’s First Amendment rights and the Dormant Commerce Clause. The court did not issue the preliminary injunction, and this decision was upheld by the Eighth Circuit in March 2021. Neither court has issued a decision on the constitutional issues, effectively allowing Missouri to enforce its meat labeling law.

Going forward, there will be a lot of controversy, and likely a lot of litigation, around the topic of labeling cell-cultured meat. Congress may attempt to settle these disputes through legislation. But with federal legislation, federal agencies like USDA and FDA will play a bigger role in how the nation regulates cell-cultured meat. Similarly, states may continue trying to reserve labeling and marketing control over the meat sold in their state, for consumers and to protect their agricultural sector. Additionally, as with any legislation, the courts are empowered to interpret whether the law is constitutionally sound. It remains unsettled how the government will address alternative protein labeling issues; the issue can potentially be resolved through federal legislation, state legislation, agency regulation, through the courts, or some combination of government acts.

As cell-cultured meat gets closer to market, decision-makers will inevitably need to balance conflicting interests. Emerging technologies like cell-cultured meat do not cleanly fit into existing regulatory frameworks. At the federal level, agencies are attempting to decide which agencies have jurisdiction over cell-cultured meat and at what points in the production process. States are considering how new technologies will shape their economies, especially in places where animal agriculture is a significant industry. States are also attempting to preserve authority over consumer protection in light of strong preemption precedent from the Supreme Court.

Producers and consumers both have a lot on the line in the labeling debate. Animal-based meat producers argue they are unfairly being forced to compete against other producers that use similar terms, despite marketing different products, and that consumers may not be able to tell what they are choosing to eat. Cell-cultured meat producers argue that prohibiting them from using accurate language unfairly disadvantages them and misleads consumers. Whether cell-cultured meat is regulated at the federal or state level, and whether their burger is from a lab or a cow, consumers should know where their food comes from. Without clear and honest labeling, consumers cannot make informed decisions about the food they purchase and consume.

Cell-cultured meat is just one example of many in novel labeling issues. States are increasingly introducing legislation that also prevents plant-based protein producers from using meat analogues in their packaging. The labeling debate brings to light other broader questions about innovation and technology in food production. Will this innovative technology solve ethical, environmental, and human health concerns about traditional meat production? Or will lab-grown meat be the next margarine: another instance where the “development of substitutes for a particular resource does not always lead to reductions of use of that resource”? Without acknowledging the unpredictable nature of complex systems, societies and economies included, new technologies rarely result in their intended consequences.