FDA concludes first premarket consultation for meat cultured from animal cells

Technology for growing meat brings cultivated chicken one step closer to U.S. markets

The Food and Drug Administration’s Center for Food Safety and Applied Nutrition announced in mid-November that it has completed its first premarket consultation for a human food made from cultured animal cells. Upside Foods will take living cells from chickens and grow the cells in a controlled environment to make the cultured meat.

The FDA stated that “the voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm’s safety conclusion.”

This voluntary premarket consultation process evaluates the safety of food made from cultured animal cells before it enters the market. The process allows developers to work with the FDA on a product-by-product basis and informs them of issues they must consider when producing safe food that does not violate the requirements of the Federal Food, Drug and Cosmetic Act. Human food made with cultured animal cells must meet the same requirements as all other food for humans. There is currently no food made from cultured animal cells available for sale in the U.S. market.

Dinner plate with cultured chicken slices and vegetable side
The cells from a single chicken allow Upside Foods to cultivate the same amount of poultry that ordinarily would come from hundreds of thousands of traditionally farmed birds. (Photos courtesy of Upside Foods)

Manufacturing chicken

Founded in 2015, Upside Foods says that the cells obtained from a single chicken enables the company to cultivate the same amount of poultry that ordinarily would come from hundreds of thousands of traditionally farmed birds.

According to the company, the production process starts by taking a sample of cells from a chicken or fertilized egg. From this sample, the team selects ideal cells for developing a commercial cell line based on their ability to produce high-quality meat grown predictably and consistently.

Once a cell line is established, the team is able to draw from that line for years to come, reducing the need to take additional animal cell samples.

The cells and cell feed are put into a cultivator, which maintains the optimal temperature and oxygen concentration for the cells to multiply. The cells are gradually scaled up to larger cultivators as the volume of tissues increases.

After about three weeks, the tissue is ready for harvest. Once harvested, the meat is ready to be inspected, prepared, packed, shipped, sold, and consumed.

Clearing regulatory hurdles

The recent regulatory decision means that the FDA has accepted Upside Foods’ safety conclusion, and the company’s cultivated chicken will be available to consumers pending inspection and label approval by the U.S. Department of Agriculture Food Safety and Inspection Service.

In March 2019, the FDA and FSIS signed a formal agreement to jointly oversee the production of cultured meat. The FDA oversees the collection, growth, and differentiation of livestock and poultry cells until cell harvest.

Then the FSIS and the FDA work together to transition oversight, in this case, as Upside Foods removes cells from the active growth environment to be prepared for traditional food processing.

Next, Upside Foods will work with the FSIS to obtain a grant of inspection for the company’s Engineering, Production, and Innovation Center and to approve the label for the company’s cultivated chicken. Once those steps are complete, Upside Foods plans to begin commercial production and sales.

Upside Foods’ transition room
Upside Foods’ Engineering, Production, and Innovation Center was designed to produce any type of meat and is capable of producing 50,000 pounds of finished meat products per year, with a future capacity of over 400,000 pounds.

Challenges ahead

A remaining issue is the labeling of cultured meat. In 2019, at least 13 states had proposed legislation that would exclude plant and cell culture products from the definition of “meat.”

The National Cattlemen’s Beef Association is leading efforts in Washington, D.C., to make sure that both current plant-based products and potential lab-produced products in the future are properly marketed and regulated. It has listed combating what the organization calls “fake meat” among its five main policy priorities in 2022.

NCBA supported a bill called Real Marketing Edible Artificials Truthfully Act of 2019—or Real MEAT Act—in October 2019. It would establish a federal definition of beef, clarify the imitation nature of these alternative protein products, and enhance the federal government’s ability to enforce the law of misbranded imitation meat. However, the bill has since not been reintroduced.

In addition, scientific and practical barriers to the commercialization of cultured beef remain. For example, further research is still needed to determine optimal methods for obtaining the starting material for production, and to select the best donor cattle based on factors such as age, gender, breed, and known muscle composition, according to an article published in the January 2021 issue of Journal of The Science of Food and Agriculture.

“As cultured meat is considered a novel food, novel regulations and regulatory oversight systems may have to be developed in parallel with the technology to ensure its consistent quality and safety,” the authors of the article, “Cultured beef: from small biopsy to substantial quantity” state.

At this time, FSIS says it does not intend to establish new food safety inspection regulations governing cell-cultured meat or poultry, given its current regulations are already applicable. However, FSIS does intend to publish new labeling regulations for such products. The agency, in an advance notice of proposed rulemaking published in September 2021, requested comments “pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act.”

Most importantly, it’s up to consumers on whether cultured meat will find its way onto dinner tables. The results of a 2020 study of 272 Brazilian veterinarians and animal scientists suggest that women, veterinarians, vegetarians, and vegans were more supportive of cell-based meat. The resistance expressed by the other respondents seemed related to the association of cultivated meat with artificiality.

This point of view is mirrored in a February 2020 Frontiers in Nutrition article that stresses, “Consumer acceptance will be strongly influenced by many factors and consumers seem to dislike unnatural food.”

Demand for meat

Global meat production has more than tripled over the past 50 years, according to data from the United Nations Food and Agriculture Organization in a report from Our World in Data. In 2020, production was about 337 million tons, compared with about 99 million tons in 1970.

Animal farming is expanding worldwide to meet the demand for meat and other animal products as the world’s population continues to grow. About 33 billion chickens were kept globally in 2020, compared with 14 billion in 2000, according to FAO data in a report from the Federal Statistical Office of Germany.

Further, the increasing prosperity in many emerging and developing countries is changing nutrition patterns, according to the report from Our World in Data. Per capita meat consumption for beef and veal, pork, and poultry has grown around 3% annually in developing and emerging economies since the mid-1990s, according to the USDA Economic Research Service, while growth of meat consumption has been only about 0.4% for developed countries.