Loyola University Chicago School of Law, JD 2025
Lab-grown meat, also known as cultured or cell-based meat, is recognized as a revolutionary innovation in the food industry. Lab-grown meat has garnered significant attention and investment because it offers a more sustainable alternative to traditional livestock farming. However, behind the promise of this cutting-edge technology lies a complex web of regulatory and compliance challenges that must be addressed to ensure its successful integration into the market.
The emergence of lab-grown meat
Lab-grown meat is produced by culturing animal cells in a controlled environment, which creates real meat without the need to raise and slaughter animals. To produce lab-grown meat, companies like Good Meat Inc. cultivate stem cells from an animal and grow them in vessels of varying sizes to maintain the right temperature, along with a mixture containing amino acids, sugars, and other nutrients. After a few weeks, the cells are harvested and formed into shapes that a consumer would recognize, like a chicken breast or a meatball.
This approach can potentially alleviate many ethical, environmental, and health concerns associated with traditional meat production. While the concept of lab-grown meat is relatively new and expensive, it has gained rapid traction in recent years. Recently, the Food and Drug Administration (FDA) has fully cleared cultivated chicken made by Good Meat Inc. as safe to eat. However, as this innovative industry matures, it faces many regulatory and compliance hurdles.
One concern for consumers and lawmakers alike is the regulation of lab-grown meat and the lack of a clear regulatory framework. Traditional meat production is subject to well-established regulations, but lab-grown meat blurs the lines between agriculture, biotechnology, and food production.
In the United States, regulatory authority is split between two agencies: the U.S. Department of Agriculture (USDA) and the FDA. The USDA oversees the production and labeling of meat products, while the FDA is responsible for regulating cell culture technology and ensuring the safety of the process. The Health and Human Services Food and Drug Administration (HHS-FDA) and the USDA have collaborated on an agreement concerning overseeing human-produced food using animal cell culture technology. The HHS-FDA will handle various aspects of the production process and ensure compliance with FDA regulations. Meanwhile, the USDA will take over regulatory oversight at harvest, including inspection and labeling of products. This multi-organizational oversight presents a potential source of confusion and delay for companies seeking to bring lab-grown meat to market.
Moreover, under the U.S. Federal Food, Drug, and Cosmetic Act (FD&CA), any substance intentionally added to food is considered a food additive and must undergo a premarket review and approval process by the FDA. Alternatively, substances can achieve regulatory compliance if they are widely recognized as safe for their intended use, termed “Generally Recognized as Safe” (GRAS). One of the ways to obtain recognition through GRAS includes providing scientific evidence established by qualified experts confirming the substance’s safety.
Other countries have established more streamlined regulatory pathways. Singapore is the only country to permit the sale of meat grown from cells outside of an animal to consumers. Good Meat’s cultivated chicken is already available in restaurants in Singapore, where it was approved for sale in 2020.
Labeling and consumer perception
The labeling of lab-grown meat is another contentious issue. Should it be called “meat,” or should it have a distinct label like “cultured meat” or “cell-based protein”? The choice of terminology can significantly influence consumer perception and purchasing decisions. The FDA does not recommend Good Meat Inc. adopt the term “cultured chicken cell material” as it is not an appropriate common or usual name for declaring the substance per the USDA labeling requirements. Labeling lab-grown meat may be established by regulation or common usage. But if there is no appropriate or common name, the company must follow a descriptive name that describes the basic nature of the food or its characterizing ingredients.
Lab-grown meat has the potential to reduce animal suffering and minimize the environmental impact of livestock farming. However, ethical questions remain, particularly regarding the use of the cell culture process. The FDA and USDA must pursue efforts to ensure that when the donor stem cells are obtained, it is a painless and safe process that leaves minimal scarring. Those unaware of the process may ask if the animal whose stem cell is cultured remains alive, what are their living conditions like, and if they continue to be subjected to multiple cell cultures.
Additionally, cultivated chicken is much more expensive than meat from farmed birds and cannot yet be produced on the scale of traditional beef. Replacing processed chicken breasts with processed cultured chicken breasts is not necessarily advantageous for human health. The question remains whether lab-grown chicken will pass the ethical test and become widely accepted.
What does the future of our meals look like?
Lab-grown meat is a game-changing innovation in the food industry. However, dealing with regulations and compliance in this field can be complex and is constantly evolving. Companies involved in lab-grown meat production face a complicated web of rules and regulations, the need to handle labeling issues, ensure safety, and grapple with ethical concerns.
As the lab-grown meat industry continues to grow and gain acceptance, having a clear and transparent regulatory framework will be crucial for its progress. Achieving this will require active collaboration between industry players, regulatory agencies, and consumers. Despite these promising developments, it might still be a while before you find a plate of lab-grown chicken breast as a common meal option.