The United Nation’s forecast of the world population reached eight billion last week.[1] Many mouths to feed. Just twelve years ago, the world became a community of seven billion people.
Population doomsayers have made portentous claims about overpopulation and starvation for some time. “In 1798, Rev. Thomas Robert Malthus predicted that population would outrun food supply on the assumption that human numbers would increase at a geometric rate while food would be limited to arithmetic increases. Then, in 1968, Stanford University professor Paul R. Ehrlich issued a similar warning in his book [The Population Bomb], in which he predicted that hundreds of millions of people would die of starvation in the 1970s and 1980s.”[2] Thankfully, these apocalyptic predictions have proven unfounded. To call them patently untrue, however, would not be entirely correct. According to a 2020 joint-report by the Food and Agriculture Organization of the United Nations and others, almost nine percent (nearly 700 million people) were hungry.[3] The problem of feeding the word will “only become more difficult, as the world will need to produce about 70 percent more food by 2050 to feed an estimated 9 billion people.”[4]
Enter lab-grown meat.[5]
Private industry has furiously jumped onto this idea. For those who absolutely abhor the idea of eating a product[6] made of one thing, be it plant-based or other ingredients, but made to look like another, lab-grown meat presents an alternative situation. It is, after all, actual meat.
One startup, Upside Foods, has just taken a large, intermediate step forward in this industry and received approval through a pre-market consultation with the Food and Drug Administration (FDA). The FDA, on November 16, 2022, “evaluated the information submitted by UPSIDE Foods as part of a pre-market consultation for their food made from cultured chicken cells and has no further questions at this time about the firm’s safety conclusion.”[7] This marks the “first time [the FDA has] cleared a meat product grown from animal cells for human consumption.”[8]
This first approval is momentous and recognizes the governing agencies’ (FDA and the U.S. Department of Agriculture jointly regulate the production of cell-cultured meat[9]) commitments to “supporting innovation in the food supply”[10] to feed the world’s population and combat climate change.[11]
The regulatory-approval hurdle is a significant feat. Upside Foods submitted a hundred-plus page report to the FDA when seeking approval over a year ago.[12] The report described the process of cultivating the lab-grown chicken, safety and quality control procedures, composition reports, and risk assessments. Pursuant to the agreement between the U.S. Department of Agriculture (USDA) and the FDA[13], “the FDA regulates the cell collection, banking, growth and differentiation of the cells, with a regulatory transition to [USDA] . . . at harvest through processing and labeling.”[14] The FDA conducts the premarket approval process by “evaluat[ing] the production process and the cultured cell material made by the production process, . . . manufacturing controls, and all components and inputs.”[15] The lab-grown meat must still satisfy the requirements of the Food, Drug and Cosmetic Act, which prohibits the “adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.”[16] The FDA’s finding of “no further questions”[17] regarding the safe production of the lab-grown meat turned in large part on the fact that the Agency did not “identify a basis for concluding that the production process . . . would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food.”[18]
This premarket review of Upside Foods’ slaughter-free poultry, while significant, is one of several major necessary elements to be completed. Once the company’s “manufacturing establishment” receives “a grant of inspection from USDA-Food Safety and Inspection Service (FSIS)” and the “product itself [receives] a USDA mark of inspection,”[19] then Upside Foods must ensure they label their product correctly. In 2016, Congress passed the National Bioengineered Food Disclosure Law, described as “comprehensive legislation to govern the labeling of bioengineered foods.”[20] The Law requires comprehensive labeling and disclosures of product composition. “Bioengineered foods” have been defined through regulation, the National Bioengineered Food Disclosure Standard, 7 C.F.R. § 66.1.[21] Upside Foods’ lab-grown poultry products fall within this standard of “bioengineered”[22] and must therefore follow the “mandatory system for disclosing the presence of bioengineered material in human food.”[23] Once a label is approved, the product will be allowed to “enter the U.S. market” for sale and consumption.[24]
Moving forward, the FDA and USDA may be expected to issue further guidance outlining the process for lab-grown meat producers to receive approval and successfully market their sustainably-farmed meat products.
[1] https://www.un.org/en/dayof8billion
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1280423/
[3] https://www.fao.org/3/ca9692en/online/ca9692en.html#chapter-Key_message
[4] https://www.worldbank.org/en/topic/climate-smart-agriculture
[5] See https://upsidefoods.com/our-science/ for a brief description of the production process of cell-cultured meat.
[6] https://www.beyondmeat.com/en-US/products/the-beyond-burger
[7] https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology
[8] https://www.reuters.com/business/healthcare-pharmaceuticals/lab-grown-meat-cleared-human-consumption-by-us-regulator-2022-11-16/
[9] https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell
[10] https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology
[11] Agriculture is a large part of the ongoing climate crisis, with 19%-29% of total greenhouse gas emissions being the result of the agriculture industry. See https://www.worldbank.org/en/topic/climate-smart-agriculture.
[12] To read the Upside Foods’ report submitted October 1, 2021, see https://www.fda.gov/media/163262/download.
[13] https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell
[14] https://www.fda.gov/food/food-ingredients-packaging/human-food-made-cultured-animal-cells
[15] https://www.fda.gov/food/food-ingredients-packaging/human-food-made-cultured-animal-cells
[16] 21 U.S.C. § 331.
[17] https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology
[18] https://www.fda.gov/media/163260/download
[19] https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology
[20] https://crsreports.congress.gov/product/pdf/R/R46183#:~:text=The%20Standard%20guides%20the%20mandatory,begins%20on%20January%201%2C%202022.&text=Bioengineered%20Foods%20(List).
[21] Bioengineered foods are:
(1) Subject to the factors, conditions, and limitations in paragraph (2) of this definition:
(i) A food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature; provided that
(ii) Such a food does not contain modified genetic material if the genetic material is not detectable pursuant to § 66.9.
(2) A food that meets one of the following factors and conditions is not a bioengineered food.
(i) An incidental additive present in food at an insignificant level and that does not have any technical or functional effect in the food, as described in 21 CFR 101.100(a)(3).
(ii) [Reserved]
Bioengineered substance means substance that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
[22] 7 C.F.R. § 66.1.
[23] https://www.fda.gov/media/163260/download
[24] https://www.law360.com/technology/articles/1550684/fda-greenlights-calif-co-s-lab-grown-chicken