As the alternative meat industry takes off, regulation will confront a new frontier.
Consumers are increasingly turning to alternatives to traditional meat. The sale of plant-based meat has more than doubled in the United States in recent years, rising by 148 percent from 2019 to 2020 alone. Some experts project that the plant-based meat industry will grow into a $252 billion market by the end of the decade. Unlike older market alternatives such as veggie burgers, plant-based meat is specifically designed to taste and feel like real meat.
Yet another booming industry is not merely a meat-like alternative—it is real meat. Cultured meat is meat grown in a laboratory from cells taken from living animals. It does not require any animal slaughter, and some researchers find that it could have a significantly smaller carbon footprint than traditional meat. Although cultured meat is not yet commercially available in the United States, experts project that this cell-based meat industry will achieve price parity with conventional meat by 2025. Cell-based meat may “significantly disrupt” the traditional meat market as it provides real animal meat with fewer environmental harms
In this uncharted territory of neither plant-based meat alternatives nor traditional meat, policymakers must create a regulatory framework for the soon-to-be booming cell-based meat industry.
In 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) reached an agreement to regulate cell-based meat jointly to ensure that, when it comes to market, cell-based meat is “safe and properly labeled.” FDA will oversee cell collection, banking, and growth, while USDA will conduct safety inspections and develop labeling for cell-based meat.
In this week’s Saturday Seminar, experts discuss regulatory issues to expect with an emerging alternative meat industry.
- In an article in the Maryland Law Review, Deepti A. Kulkarni of Georgetown Law argues that a “turf war” over statutory authority has hindered attempts to regulate food grown using emerging technologies, such as cultured meat. Kulkarni explains that FDA, USDA, and the U.S. Environmental Protection Agency (EPA) share statutory authority to regulate foods created through the use of biotechnology. According to Kulkarni, these agencies are only just beginning to use their authority to implement science-based policies to address cultured meat in a coordinated, efficient, predictable, and scalable way.
- The United States needs a strategy to regulate cell-based meat, argues Jennifer Penn in a UCLA Journal of Law and Policy article. Penn argues that the FDA Commissioner should introduce new regulations that define and set standards for cultured meat, rather than trying to fit it into existing categories of FDA-covered products. Once FDA certifies that cultured meat is safe, USDA should oversee the day-to-day regulations, Penn argues. She suggests that USDA should hold cultured meat to the exact same dietary regulations and quality assessments as regular meat.
- In an article in the Kentucky Journal of Equine, Agriculture, and Natural Resources Law, Brian P. Sylvester, Nathan A. Beaver, Kara Schoonover, and Jonathan I. Tietz argue that regulators should look to the examples of cloned meat and bioengineered meat when deciding the best path forward for cell-based meat. When regulating cloned meat—meat “from cloned animals or their offspring”—FDA has applied a “probabilistic and pragmatic” safety-assessment approach that relies heavily on peer-reviewed scientific data and emphasized risk-based regulations. Similarly, the approach for bioengineered meat, or meat that has been genetically modified in vitro, includes a premarket consultation process. Sylvester and his coauthors argue that a similar consultation process would foster innovation and improve consumer confidence if applied to cell-based meat. Sylvester and his coauthors urge regulators to provide proactive guidance for this new market.
- State laws prohibiting manufacturers of plant-based foods from labeling their products as “meat” violate the U.S. Constitution, according to Jareb A. Glekel of Verdict and Sherry S. Colb of the Cornell University School of Law. Gekel and Colb claim these so-called tag-gag laws violate several constitutional provisions, including the Supremacy Clause and the First Amendment. They suggest several innovative ways to challenge these restrictions, including claiming marketing materials are a form of political speech subject to heightened protection by courts. Free speech provisions in state constitutions provide another avenue for challenging restrictions on plant-based food labeling, according to Gekel and Colb.
- The U.S. Congress can and should confer additional intellectual property protections on cell-based meat using the Hatch-Waxman Act, argues attorney Sean A. Grafton in an article published in the Catholic University Journal of Law and Technology. The Hatch-Waxman Act currently allows manufacturers of generic drugs to obtain patents on their products if the brand-name version of a drug has already been proven safe. Grafton explains that cell-based meat could benefit from similar protections, given that it will likely take an extended period of time for many cell-based meat products to gain FDA approval. Granting cell-based meat products patent protection under the Hatch-Waxman Act would allow immediate competition in this rapidly growing market by speeding up the usually cumbersome patent approval process without compromising safety, Grafton argues.
- In a Frontiers for Sustainable Food Systems article, Raychel E. Santo of the John Hopkins Bloomberg School of Public Health and several coauthors outline policy issues surrounding plant-based meat, including an opaque approval process, a lack of funding for oversight, unclear labeling standards, and confusion over which agency should regulate the product. Santo and her coauthors discuss consumer advocacy concerns about the FDA approval procedure for plant-based meat, which allows manufacturers to self-certify that their products comply with safety standards. They also suggest that the current lack of congressionally appropriated funding for regulation of plant-based meat constrains FDA and USDA by limiting their ability to hire additional personnel. In addition, Santo and her coauthors note the possibility of federal legislation that could limit the marketing of plant-based products as “meat.” They claim such legislation could provide greater clarity over how the USDA and FDA should divide regulation of plant-based meat and address issues such as labeling and transparency standards.
The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.