April 01, 2020

New Regulatory Frameworks for Cell-Cultured Meat

Sarah Kettenmann and Bridget Lamb

The development of cell-cultured meat—also referred to as “clean meat” or “lab-grown meat”—has quickly gained the attention of scientists, regulators, and consumers alike. While promising to be environmentally sustainable, cell-cultured meat has faced backlash from various industry stakeholders and lobbyists aiming to preserve more traditional forms of meat products. This article explores the current regulatory status of cell-cultured meat.

First, what is cell-cultured meat? It is a food product that is derived from animal cells but grown and harvested by scientists in laboratories. Cell-cultured meat can come from any animal traditionally raised for consumption including beef, poultry, swine, and fish. The process for growing cell-cultured meat is complex: cells are either collected through the biopsy of a living animal or taken from one recently slaughtered. The cells are grown in multiple stages to differentiate and mature. While differentiation allows the meat to have distinct texture and cellular form—picture the marbling of a steak—maturation is more complex and expensive. Maturation requires the cells to be placed into a type of scaffolding, and to grow in a nutrient-rich broth complex enough to sustain life. Alan Sachs & Sarah Kettenmann, A Burger by Any Other Name, 15 SciTech Lawyer 19 (Winter 2019).

Once cell-cultured meat can be produced at scale, environmental and social benefits are vast. Water consumption and land use from raising livestock could be reduced exponentially. Grain grown for animals, and the energy required to grow and harvest crops, could be used elsewhere. The uniform production could make meat products more affordable for low-income purchasers. Moreover, because the product is created in a sterilized laboratory environment, risks of animal-borne disease spreading to humans are lower.

As interest in cell-cultured meat grows, lawmakers around the globe are working to clarify which regulatory frameworks will apply to the growth and harvest of the product, and how it will be labeled and marketed to consumers. An immediate concern is that this food product implicates both livestock and non-animal rules. Although it is indisputably sourced from an animal, it is cultured in a sterile laboratory. It does not require, for example, feeding or slaughterhouse operations inspections; instead, regulatory inspections may be similar to those for biotechnology laboratories.

In the European Union (EU), cell-cultured meat most likely will be regulated under the Novel Foods Regulation. Ludivine Petetin, Frankenburgers, Risks and Approval, 5 Eur. J. Risk Reg. 168 (2014). Novel foods are those that were not consumed “to a significant degree” by humans before May 15, 1997, and may have been developed using new technologies. European Commission, EU2015/2283. The EU requires that novel foods are safe for consumers and properly labeled so as not to mislead consumers. European Commission, EU2015/2283. As of the writing of this article, the EU had not yet confirmed that cell-cultured meat will be regulated as novel foods, however. Consumers in Asian countries like China, India, Vietnam, and Thailand have expressed interest in cell-cultured meat, but regulatory bodies have not responded to lift potential regulatory barriers to the new product.

On the other hand, in March 2019 the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) issued a joint framework to regulate cell-cultured meat. See Formal Agreement between the U.S. Department of Health and Human Services Food and Drug Administration and U.S. Department of Agriculture Office of Food Safety (Mar. 7, 2019). The FDA will oversee the cell collection and maturation processes, then coordinate with FSIS when the product is harvested to determine whether it should bear the USDA mark of inspection. The agencies will work together to ensure that product labeling is consistent and transparent. In December 2019, senators from Wyoming and Montana introduced legislation to codify the terms of this formal agreement. Food Safety Modernization for Innovative Technologies Act, S. 3053, 116th Cong. (2019).

Before the joint framework, consumers, lobbyists, and legislators already had brought labeling concerns to court. Sparring between the current animal agriculture industry and alternative meat producers escalated in February 2018 when the U.S. Cattlemen’s Association (USCA) submitted a petition to FSIS. The USCA requested that FSIS establish certain meat and beef labeling requirements, including prohibiting any food product not derived from harvesting an animal from using the word “beef” in its advertisement. This petition ignited the debate on cell-cultured meat. FSIS has received over 6,000 comments regarding the USCA petition, but has not yet issued a final response.

With the possibility of cell-cultured meat production reaching scalable levels in the near future, several U.S. states have also faced regulatory pushback against its impending entry into the market. States with industries that revolve heavily around animal agriculture have experienced the most regulatory activity so far.

Missouri was the first state to take preemptive measures against potential mislabeling of cell-cultured meat. Missouri passed Senate Bill 627 in August 2018 to amend the Missouri Meat Advertising Law and address the future marketing of cell-cultured meat. The Meat Advertising Law, enacted in 1985, prohibits the misleading or deceiving advertising of meat. Mo. Rev. Stat. § 265.492. But since the law was enacted decades before recent advances in biotechnology, it did not differentiate between meat products attained through slaughtering livestock and those manufactured in a lab. Further, it did not include terms applicable to plant-based “meat” products.

The 2018 amendments explicitly prohibit representing a product as meat “that is not derived from harvested production livestock . . . or poultry.” Mo. Rev. Stat. § 265.494(7). Violators are subject to up to one year in prison and $1,000 in fines. In support of the amendments, the Missouri Department of Agriculture (MDA) aimed “to promote transparency for consumers while balancing that with common sense to minimize the market disruptions for existing products.” MO Dept. of Agriculture, Missouri Meat Advertising Law, Public Statement—Meat Labeling (Aug. 30. 2018). After studying applicable state and federal standards, visiting stakeholders, and evaluating existing products, the MDA concluded that a product is not in violation of mislabeling, and does not misrepresent itself as meat, if its packaging clearly states that it is either made from plants or grown in a lab. This distinction must be evident directly in the product name, or prominent elsewhere on the packaging. Although the amendments have only been applied to existing products thus far, they appear to lay the framework for regulation of future products, including cell-cultured meat. The MDA plans to revisit these standards once cell-cultured meat has been introduced to the consumer market.

Alternative meat producers and animal rights activist groups were quick to show their disapproval of Missouri’s new law. Tofurky (a top producer of plant-based “meats”), the Good Food Institute, the American Civil Liberties Union of Missouri, and Animal Legal Defense Fund filed a lawsuit in federal district court in Missouri claiming that the SB 627 amendments were unconstitutional. They argued that the law “prevents the sharing of truthful information and impedes competition by plant-based and clean-meat companies in the marketplace.” See Nicole Pallotta, Missouri Passes Unconstitutional Law Restricting the Marketing of Alternative Meat Products, Animal Legal Defense Fund article (Nov. 8, 2018). The lawsuit challenged the MDA’s claim that the amendments were necessary to avoid consumer confusion. The plaintiffs argued that plant-based “meats” have been on the market for a long time, and have never confused consumers, because the ingredients were already clearly listed on each product. Instead, they suggested that the new law was enacted to protect the animal agriculture industry from the increasing consumer demand for plant-based and cell-cultured products. The lawsuit is ongoing.

Mississippi recently passed Senate Bill 2922 after the Mississippi Cattlemen’s Association voiced concerns about meat product labeling. Analogous to Missouri’s recent amendments, Mississippi’s new law bans the marketing of any plant-based or cell-cultured product as “meat.” See Miss. Code § 75-35-15 (2019). Mississippi’s law took effect in July 2019, and faced immediate objection from alternative meat producers and advocates. Upton’s Naturals, an Illinois-based manufacturer of plant-based meat products, and other plaintiffs filed a lawsuit in federal district court against Mississippi Governor Phil Bryant and Agriculture Commissioner Andy Gipson. Upton’s Naturals Co. v. Bryant, Case 3:19-cv-00462 (S.D. Miss. filed July 1, 2019). Plant-based and clean meat supporters asserted that the new law breached manufacturers’ constitutional rights and placed such manufacturers at a disadvantage in the marketplace. But advocates for tougher Mississippi labeling restrictions on alternative meat products claim that they intend to provide transparency to consumers, referring to this as a “truth-in-label” issue. See, e.g., Jeff Amy, Mississippi Lawmakers Have Real Fears About ‘Fake Meat,’ AP News (Mar. 2, 2019). Agriculture Commissioner Gipson acknowledged that the mislabeling of alternative meat products could be “detrimental to the foods they attempt to imitate, emulate, follow or profit from,” a concern shared throughout the animal agriculture industry. Id.

The lawsuit pressured the Mississippi Department of Agriculture to propose a regulation to nullify the terms of SB 2922 as to plant-based products. Those regulatory revisions were adopted in November 2019. 2 Miss. Admin. Code Pt. 1, Subpt. 4, R. 07.01, 112 (adopted Nov. 6, 2019). The revised regulation allows plant-based meat imitation products to market themselves as meat—so long as the packaging contains a statement that the product is made from plants or another comparable qualifier. The revised regulation also suggests, but does not require, that food retailers separate plant-based meat and actual meat products in different sections of their stores. These regulatory changes were considered a victory for plant-based product manufacturers, and Upton’s Naturals dropped its lawsuit. The revised Mississippi regulation does not exempt cell-cultured meat products from the restrictions imposed by SB 2922, however. Indeed, cell-cultured meat may be regulated more strictly than plant-based products in the future.

Legislation to redefine labeling terms applicable to cell-cultured meat also was proposed in Colorado in 2019. House Bill 19-1102 addressed the misbranding of foods. It would have banned any product that does not come from an animal from being labeled as meat, and would have mandated that any cell-cultured product denote its origin. Although this bill ultimately did not pass, Colorado did pass House Resolution 19-1005 in April 2019, requesting that the FDA promptly provide guidance on the labeling of cell-cultured meat.

Alabama, Arkansas, Kentucky, Louisiana, Montana, North Dakota, Oklahoma, South Dakota, South Carolina, and Wyoming have also begun to consider regulating cell-cultured meat before it even enters the marketplace. As the anticipation grows around the debut of cell-cultured meat, and without further guidance from the FDA and FSIS, it seems that more and more states will be asked to address and design regulatory frameworks for the manufacture, marketing, and labeling of cell-cultured meat. Like the meat products that are proposed, such regulatory frameworks may mature and differentiate. Perhaps the greatest risk that manufacturers, producers, and lawmakers face is the inconsistent development and application of regulations to this new product.

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Sarah Kettenmann and Bridget Lamb

Ms. Kettenmann is an associate and Ms. Lamb is a legal administrative assistant in the New York office of Beveridge & Diamond P.C. They may be reached at skettenmann@bdlaw.com and blamb@bdlaw.com, respectively.