Well Done


In a historic decision, the United States Department of Agriculture (USDA) has approved two companies, Upside Foods and GOOD Meat, to market lab-grown chicken in the United States.

The final approval follows the US Food and Drug Administration’s (FDA’s) issuance of "no questions" responses to GOOD Meat and Upside Foods’ letters concluding that foods comprised of or containing cultured chicken cell material resulting from their proprietary production processes are as safe as comparable foods produced by other methods.

Notably, FDA’s responses advised the companies to ensure that foods produced using lab-grown meat continue to comply with legal and regulatory requirements, and to consult with FDA if the companies introduce new production procedures, cell lines, or substances during production.

The approval of cell-cultivated chicken follows FDA’s determination that AquAdvantage's bioengineered salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act, and reflects growing food industry interest in genetically engineered/cultivated meat and seafood products.

Regulatory Oversight: A New Pecking Order

Establishments that harvest cells for cell-cultured meat and poultry food products are dual jurisdiction establishments. FDA and USDA’s Food Safety and Inspection Service (FSIS) jointly oversee the production of cell-cultured meat and poultry food products and share information necessary to carry out their respective oversight responsibilities. Cell-cultured meat and poultry food products are subject to the same FSIS regulatory requirements and oversight authority as meat and poultry food products derived from the slaughter of live animals.

Regulatory oversight is based on the agencies’ existing jurisdiction over meat products. FDA is responsible for regulating all live animals to be used as food up until they are presented for slaughter.

For animals intended for human consumption and regulated under the Federal Meat Inspection Act (FMIA) (i.e., cattle, sheep, swine, goats, and fish of the order Siluriformes) or the Poultry Products Inspection Act (PPIA) (i.e., chicken, turkeys, duck, geese, guineas, ratites, and squab), FSIS is responsible for regulation during slaughter, processing, packaging, and labeling. For foods not regulated under FMIA or PPIA (e.g., seafood and game meat) or foods intended for animal consumption, FDA has sole jurisdiction.

In 2019, FDA and FSIS entered into an agreement to jointly oversee the production of cell-cultured meat and poultry food products and to share information necessary to carry out their respective oversight responsibilities. Under the agreement, FDA has jurisdiction over the preharvest production phase of the animal cell culture process. Jurisdiction transfers to FSIS at harvest, when the cell-culture establishment commences the process of removing the cells from the controlled environment. FSIS also oversees the postharvest processing and labeling of cell-cultured meat and poultry food products.

From Petri Dish to Plate

Lab-grown chicken, also known as cell-cultured or cell-cultivated meat, is produced by taking animal cells and growing them into tissue inside a controlled environment, such as a stainless-steel bioreactor. The production process of cultured meat involves two stages: preparation of master cell banks and cultured poultry meat production.

The first stage includes cell line isolation, generation, and banking. The second stage includes cultured media and food contact articles, cell seed train, and integral meat tissue maturation. After the cells have multiplied many times over into billions or trillions of cells, additional factors (e.g., protein growth factors, new surfaces for cell attachment, additional nutrients) are added to the controlled environment to enable the cells to differentiate into various cell types and assume characteristics of muscle, fat, or connective tissue cells.

Once the cells have differentiated into the desired type, the cellular material can be harvested from the controlled environment and prepared using conventional food processing and packaging methods. The process controls include contamination, growth environment, harvested product, and batch history controls.

The result is meat that is grown directly from animal cells, offering an alternative to traditional meat production and potentially reducing the need to raise and slaughter chicken. One of the main driving forces behind the development of lab-grown meat is its potential to reduce the environmental impact of traditional meat production. Lab-grown chicken generates significantly fewer greenhouse gas emissions, requires less land and water, and has a smaller carbon footprint than conventionally produced meat.

Key Takeaways

If consumers warm to it, FDA and USDA’s approval of cell-cultivated meat and poultry could signal a seismic shift for the industry. The approval raises questions on potential markets for cell cultivated meat.

For example, USDA has not stated whether cell-cultivated chicken will be allowed to be sold into the national school lunch program. Cultivated chicken is much more expensive than meat from whole, farmed birds and cannot yet be produced on the scale of traditional meat.

The companies plan to serve the new food first in exclusive restaurants. Upside has partnered with a San Francisco restaurant called Bar Crenn, while Good Meat dishes will be served at a Washington, DC, restaurant called China Chilcano. As the companies scale production, they expect their product to be sold in supermarkets within a few years.

FDA’s responses to Good Meat and Upside Foods’ letters indicate that food safety, compared to traditional animal meat products, was the most important consideration in greenlighting the cell-cultured meat. The companies were required to submit a detailed safety assessment for the cultured chicken cell material, as well as supporting, corroborative information in a supplemental confidential appendix to show that cell-cultivated chicken products are as safe as comparable foods produced by other methods and would not contain substances that adulterate the food.

FDA’s primary concern was the potential for bacterial contamination during the manufacturing process. As such, the companies’ assessments included a description of process controls for the prevention of bacterial contamination, safety/quality controls and testing, and an ongoing environmental monitoring plan.

Going forward, new entrants to the market will need to specify the steps and precautionary measures taken at each stage of the production process to prevent potential adulteration or safety concerns as part of their production process.