I. Introduction
This paper presents a comprehensive review of lab-grown meat (or, cultivated meat),Footnote 1 a revolutionary advancement in food science that produces animal-based meat without the need for animal slaughter. This paper will review the production process, analyzing the potential and promised benefits the technology may offer while considering its drawbacks and limitations. Though in development for several decades, lab-grown meat went from possibility to reality with the recent U.S. Food and Drug Administration (“FDA”) and U.S. Department of Agriculture (“USDA”) approvals of products from cultivated meat companies GOOD Meat and UPSIDE Foods for sale to U.S. consumers.Footnote 2
We assess the standards and procedures implemented by GOOD Meat and UPSIDE Foods prior to their approval and relate these standards and procedures to the current regulatory framework. Finally, this paper offers suggestions for FDA and USDA to consider in its approach to regulating cultivated meat products, with an emphasis on consumer safety and product quality, as these products enter the U.S. market and the global food system.
II. What is Lab-grown Meat?
Lab-grown meat is an innovative and rapidly developing technological advancement in food science.Footnote 3 These “lab-grown” products are produced through culturing and replicating living cells sourced from conventionally farmed animals.Footnote 4 In a closely monitored and controlled environment, cells are grown, cultivated, and shaped into meat ready for human consumption.Footnote 5 The result is wholesome meat that is structurally identical to meat taken from slaughtered animals, yet lab-grown meat does not require any animals to be slaughtered or even harmed.Footnote 6 Beyond these considerations for animals, lab-grown meat products also offer several potential benefits that may revolutionize the food industry.
Importantly, lab-grown meat is entirely different from the various plant-based meats that have gained popularity in recent years. Plant-based meat is a food product that mimics the taste, texture, and appearance of conventional meat but is created using plant material and plant proteins.Footnote 7 By contrast, lab-grown meat is created with and composed of animal cells and proteins.Footnote 8 Unlike lab-grown meat, plant-based meat is not meat in the traditional sense.
A. Making Chicken Without the Chicken
While different companies may have unique processes which they often keep confidential, the general process for producing cultivated meat (see Figure 1) begins with a cell sample collection taken from an animal or an animal product, such as a chicken, an egg, or a cow.Footnote 9 This is typically non-lethal and generally does not harm the animal.Footnote 11 These cell samples are then analyzed and tested so that the best cells can be selected for cultivation.Footnote 12 Cell cultivation begins when cells are placed in sterile environments containing nutrients designed for cell growth.Footnote 13 This may initially take the form of a petri dish or a test tube, but as the cells begin to replicate and grow, they are later transferred to larger and larger containers until they are finally placed in a bioreactor.Footnote 14
Figure 1. The Production Process of Cultured Meat.Footnote 10
In the bioreactor, the cells continue to multiply until they are ready for the differentiation process.Footnote 15 At this stage, specific substances — such as protein growth factors — are added to promote cell attachment and differentiation into different types of cells, such as muscle, fat, or connective tissue cells.Footnote 16 These different types of cells mirror those found in conventional meat. After differentiation, the meat products are harvested and prepared using conventional food processing methods.Footnote 17 At this stage, the product is handled and treated the same as conventional meat.Footnote 18
During every stage of this process, producers employ rigorous aseptic techniques, testing, monitoring, and other safety and control measures to ensure a high-quality final product.Footnote 19 The standards used by the most prominent cultivated meat producers today, including GOOD Meat and UPSIDE Foods, are comparable to the standards used in biopharmaceutical manufacturing.Footnote 20 While safety and quality are some of the most important considerations in the production process, these rigorous quality control standards are inherently required throughout many stages of production. Any contaminants or unintended substances, especially in the earlier stages, may cause the entire production run to fail.Footnote 21
B. The History of Cultivated Meat Development
Though cultivated meat is a novel technology and novel food product, the science that makes it possible emerged as early as 1912, when French surgeon and biologist Alexis Carrel began developing and maintaining an in vitro culture of living cells.Footnote 22 Practical uses for in vitro cell cultures in the agricultural sector remained mostly theoretical until 1995, when USDA approved and began regulating in vitro potency tests in place of animal tests for immunogenicity.Footnote 23 The first cell cultivated tissue was developed by Oron Catts and Lonat Zurr in 1996.Footnote 24 The late 1990s saw several patents related to tissue-engineered meat production filed and granted.Footnote 25 In 2002, NASA, in collaboration with Morris Benjaminson, tested the cultivation of fish muscle as a potential food source during space travel.Footnote 26
Throughout the early 2000s, research of, development of, and investment in cell cultivation technology began to increase.Footnote 27 The production of the world’s first cell-cultured, meat-based beef burger by Dutch scientist Mark Post led to another wave of interest in the technology, despite the $325,000 cost of creating the single burger patty.Footnote 28 From 2013–2022, the number of cultivated meat companies worldwide increased from 2 to 156.Footnote 29 In 2020, Singapore made history by becoming the first country to approve the sale of cell-cultured chicken for human consumption.Footnote 30 By 2020, the company Mosa Meats developed cultivation processes which did not require fetal bovine serumFootnote 31 — a development that likely reduced production costs and increased accessibility across the industry. Most recently, and perhaps most significantly, the companies UPSIDE Foods and GOOD Meat received regulatory clearance from FDA and USDA in 2023 to sell their cultivated meat products to U.S. consumers.Footnote 32 This development is a major regulatory breakthrough and is a central focus of this article.
Collectively, these developments demonstrate the exponential evolution of the cultivated meat industry. Decades of science and progress have culminated in the development of a technology that had formerly been dismissed as science fiction. However, cultivated meat has a long road ahead and must overcome several hurdles before it threatens to compete with or replace conventional meat. Nevertheless, many proponents of the cultivated meat industry are optimistic about current trends in its development.
III. The Promise of Lab-grown Meat
A. Promises of Environmental Benefits
While comparative figures cannot be truly accurate until lab-grown meat matches conventional meat production levels, there is a near consensus that production of conventional meat requires significantly more resources and causes significantly more environmental harm than the production of lab-grown meat.Footnote 33 Conventional meat production and the increasing global demand for animal-based foods are among the largest drivers of global deforestation and climate change.Footnote 34 A review of environmental impact studies comparing various protein sources found that “when compared to European conventionally produced livestock meat, cultured meat had substantially lower [greenhouse gas] emissions, land requirements and water use.”Footnote 35
The energy needed for production of cultivated meat was found to be potentially lower when compared to conventional beef but potentially higher when compared to poultry.Footnote 36 Although these results are “preliminary rough estimates” and future developments in renewable energy may allay concerns associated with energy usage, establishing relative energy efficiency will be a significant hurdle in establishing the viability of cultivated meat as a sustainable alternative to conventional meat.Footnote 37 However, available evidence suggests that cultivated meat is generally more sustainable than animal-based protein sources in all other areas of concern. A comprehensive comparison of the energy use, global warming potential, and land use of various protein sources is depicted in Figure 2.
Figure 2. Environmental Impact of Different Protein Sources.Footnote 38
The sustainability of cultivated meat can be logically understood when considering that cultivated meat does not waste resources growing the unusable parts of an animal. Animals, even farmed animals, are not inherently designed to be meat for human consumption. To produce chicken meat products in conventional meat production, the entire chicken must be raised, including feathers, organs, and other parts unsuitable for human consumption. Uses are occasionally found for some of these inedible byproducts, but some parts have less practical use and are often disposed of.Footnote 39 An example of this is the systematic disposal of male chicks in the egg industry.Footnote 40
Additionally, animals produce large amounts of waste. This waste is often collected in lagoons and used in spray fields, both of which have been shown to seriously threaten the environment and pose public health risks.Footnote 41 For cultivated meat production, there is very little animal waste produced, as the production process only grows meat that will be consumed.Footnote 42 Per the prescient prediction of Sir Winston Churchill, “[w]e shall escape the absurdity of growing a whole chicken in order to eat the breast or wing by growing these parts separately under a suitable medium.”Footnote 43
B. Promises of health benefits
1. Zoonotic disease
Zoonotic diseases, which are diseases transmitted from animals to humans, pose a massive risk to human health and safety. COVID-19 is a recent and notable example but is joined by several other prominent public health concerns such as: H5N1 (avian) and H1N1 (swine) influenzas, Ebola, SARS, MERS, HIV, Lyme disease, Rift Valley fever, and Lassa fever.Footnote 44 Roughly sixty percent of known infectious diseases and seventy-five percent of emerging infectious diseases are zoonotic.Footnote 45
Climate change and an increasing global demand for meat have been found to be large drivers behind the increase in zoonotic diseases.Footnote 46 Conventional meat production, especially in factory farms, often serves as a breeding ground for these diseases as well as an opportunity for them to jump from animals to humans.Footnote 47 Decreasing the consumption of animal-sourced meat worldwide would theoretically help reduce the likelihood of zoonotic diseases emerging and spreading; however, this would only be one factor in a multi-pillared approach.Footnote 48
Traditionally, efforts to decrease animal-sourced meat consumption involve promoting plant-based diets or plant-based meat alternatives to reduce demand for meat.Footnote 49 Cultivated meat has potential to become a way to reduce reliance on animal-sourced meat without requiring anyone to give up meat consumption. If cultivated meat becomes a readily available alternative to conventional meat, it may lead to a significant reduction in the risk posed by zoonotic disease worldwide.Footnote 50
2. Antimicrobial Resistance
The development of antibiotics is one of the most significant advancements in modern medicine.Footnote 51 However, organisms that develop resistance to these antibiotics threaten these advancements and may lead to significant human health risks.Footnote 52 The Centers for Disease Control and Prevention (“CDC”) estimated that, in 2019, antibiotic-resistant microbes caused nearly 3 million infections and 48,700 deaths in the United States.Footnote 53 A serious concern related to antimicrobial resistance is the emergence of “superbugs,” diseases which are resistant to any available medical treatment.Footnote 54
Unfortunately, this concern is not speculative or conjectural. In 2016, a strain of E. Coli carrying a gene making it resistant to an antibiotic called colistin was found in a Pennsylvania woman.Footnote 55 This Mcr-1 gene has since been found in “livestock, meat, and people on most continents,” as well as in pig slaughterhouses in South Carolina and Illinois.Footnote 56 The emergence of this gene and the colistin-resistant strain of E. Coli were linked to the unregulated use of colistin in Chinese animal agriculture feed.Footnote 57 The gene causing the resistance to colistin has potential to conjugate and spread to other types of bacteria.Footnote 58
Infectious disease expert Dr. Barbara E. Murray said: “Colistin has become the last go-to antibiotic for some of our multidrug-resistant bacteria … . When you’re left with only one drug and now you see resistance developing to it, it’s very concerning.”Footnote 59 Dr. Murray noted that this type of drug resistant bacteria creates situations where patients and doctors have no treatment options.Footnote 60 Other researchers suggest that “we are rapidly approaching a post-antibiotic era in which common infections and minor injuries can kill again unless immediate and proactive action is taken.”Footnote 61
a . FDA’s Role
A 2016 clinical review of PubMed (2000-2016), NIH RePORTER, and ClinicalTrials.gov databases led by Dr. Anthony S. Fauci found an association between “antibiotic consumption by animals and the existence in humans of commensal organism resistant to the same antibiotic classes,” as well as “reports of resistant pathogens passing from humans to animals.”Footnote 62 Concerns relating to the use and overuse of antibiotics in conventional animal agriculture led to policies in Europe banning their use in some casesFootnote 63 and guidance from FDA encouraging similar avoidance.Footnote 64 FDA began making efforts to curb the use of antibiotics by livestock producers as early as 2012 and continues those efforts today.Footnote 65
These FDA actions are driven by “a public health imperative,” according to Michael R. Taylor, former Deputy Commissioner for Foods at FDA.Footnote 66 Yet the use of antibiotics in animal husbandry practices remains prevalent today. One practice that is a particular concern for FDA is the use of long-term low-dose antibiotics to promote the growth of farmed animals.Footnote 67 This practice was first discovered and quickly became a common industrial practice in the 1940s.Footnote 68 In 2016, FDA estimated that seventy-four percent of antibiotics used in animals were administered through feed “to promote animal growth, rather than to treat or prevent infection.”Footnote 69 In 2022, use of medically important antimicrobial drugs approved for use in food-producing animals increased slightly from 2021 but was down thirty-six percent from its 2015 peak.Footnote 70 Any reduction in antibiotic overuse and misuse is promising, yet the continued use of over six million kilograms annuallyFootnote 71 of medically important antimicrobial drugs is nevertheless concerning.
b . Potential Cultivated Meat Solutions
Antibiotic use in conventional meat production accounts for up to eighty percent of total antibiotic consumption, and an estimated sixty-two percent of the antibiotics used are considered “medically important” compounds that have a role in treating human disease.Footnote 72 Antibiotic use is necessary to prevent disease in many cases, especially in preventing the spread of diseases in concentrated animal feeding operations.Footnote 73 However, the practice of indiscriminate preventative dosing of antibiotics to entire flocks of birds or herds of cattle or pigs is being used in some farming practices in place of good sanitation techniques.Footnote 74
By stark contrast, antibiotics are rarely used in the production of cultivated meat, and in many cases are not used at all.Footnote 75 The FDA Center for Veterinary Medicine began a multi-phase action plan in 2018 called “Supporting Antimicrobial Stewardship in Veterinary Settings.”Footnote 76 The goal of this plan was to limit or reverse antibiotic resistance stemming from antibiotics used in animals over a five-year period. As part of this plan, FDA announced in June of 2023 the successful implementation of GFI #263, which requires veterinary prescriptions for any use of medically important antibiotics in animals.Footnote 77
In congruence with this plan and FDA’s ongoing concerns about antimicrobial misuse and antimicrobial resistance, FDA should consider the development of cultivated meat as a potential strategy to help curb the overuse of antibiotics in animal agriculture operations. FDA has very little authority to regulate farming practices and conventional meat production, yet the agency has significant authority over the regulation of cultivated meat.Footnote 78 While cultivated meat is not yet a readily available alternative,Footnote 79 it has potential to become a safe and reliable source of clean meat. Carefully considered regulatory policies could bolster this industry. This could include strategies to mitigate the current use of antibiotics in animals without negatively impacting the food system. FDA must play a central role in the development of the lab-grown meat industry by advancing these crucial mitigation strategies.
3. Global Food Insecurity
According to a report from the World Food Programme, as many as 783 million people are facing chronic hunger, with more than 333 million people facing acute food insecurity.Footnote 80 As populations rise, global food demand and global food insecurity are expected to increase significantly.Footnote 81 Cultivated meat has several features and benefits that could potentially ameliorate several issues related to global food insecurity. While still largely theoretical, cultivated meat produced at scale could dramatically improve many aspects of the four pillars of food security: food availability, access, utilization, and stability.
a . Food Utilization
The issue we face today with global food insecurity is less of an issue with lack of food but rather one of inefficiency in food production.Footnote 82 Current global food production is sufficient to feed more than 9.7 billion people, the projected global population in 2050, yet the majority of this food is not used for human consumption.Footnote 83 In 2011, despite using eighty-one percent of agricultural land, animal agriculture only resulted in eighteen percent of global calorie supply while the nineteen percent of agricultural land used to grow food for direct human consumption resulted in the remaining eighty-two percent of global calorie supply.Footnote 84 This is largely due to the inefficient feed conversion rates of conventional animal products.Footnote 86 As is depicted in Figure 3, cultivated meat is substantially more efficient than conventional meat in converting feed into food.Footnote 87 Assuming production rates can sufficiently increase, a global transition to cultivated meat would allow global demand for meat to be met while also substantially reducing the amounts of agricultural land required for conventional meat production. One study estimates that “if everyone shifted to a plant-based diet we would reduce global land use for agriculture by seventy-five percent.”Footnote 88 Due to its efficiency, similar results may be possible following a global shift to cultivated meat. This land could then be better utilized to grow more food for direct human consumption, further increasing access to food.
Figure 3. Comparison of Various Meats’ Feed Conversion Ratios.Footnote 85
b . Food Availability
Cultivated meat could allow agricultural lands currently used for animal agriculture to be converted to lands used to grow food for direct human consumption, which could substantially increase food availability. A study on global agricultural yields of crops found that “growing food exclusively for direct human consumption could, in principle, increase available food calories by as much as seventy percent, which could feed an additional four billion people.”Footnote 89 By additionally utilizing grazing land, which currently makes up around sixty-seven percent of agricultural land,Footnote 90 even larger quantities of food could be grown for human consumption. While supply chain issues and problems with food waste are other substantial factors that must be addressed,Footnote 91 the potential increase in food production made possible by a global transition to cultivated meat could significantly reduce global food prices and increase global food availability.
c . Food Access
Although many of the potential benefits of cultivated meat are based on a comparison with conventional meat, one benefit that is unique to cultivated meat is the flexibility of production location. Cultivated meat production facilities can be built much closer to population centers, depending on zoning laws, as the facilities require much less space and are much less of a nuisance than many animal agriculture operations, especially Concentrated Animal Feeding Operations (CAFOs)Footnote 92 or slaughterhouses.Footnote 93 Further, cultivated meat production facilities can theoretically be built in areas where conventional animal agriculture may be difficult or impossible, including barren lands or areas subject to extreme weather.Footnote 94 This flexibility could significantly increase access to meat in many regions facing significant food insecurity. One South African cultivated meat company, WildBio (formerly known as Mogale Meat), plans to make affordable cultivated meat products accessible throughout Africa as a solution to food security issues.Footnote 95
d . Food Stability
There are several aspects of cultivated meat that promote stability and consistency in food production. One of the more promising — and proven — features of cultivated meat technology is the speed of the production cycle. Production of conventional meat can often take several months or even years,Footnote 96 but cultivated meat producers have reduced the production time to mere months or weeks. GOOD Meat claims that “the manufacturing process takes about a month.”Footnote 97 One Dutch company, Meatable, has refined their process and can go “from cell to sausage in only eight days.”Footnote 98 Further, the utilization of Master Cell Banks (MCB), which is common across the industry and often used in biopharmaceutical production as well, can help to guarantee consistent product quality as well as predictable and controlled nutritional makeup.Footnote 99 This includes controlling the specific ratio of fat to muscle,Footnote 100 as well as controlling nutritious components such as vitamins and minerals in the product.Footnote 101 The combination of these features supports stability in the food system — high-quality meat with a consistent and controlled nutritional makeup that can be produced more rapidly than conventional meat.
This technology can be paired with techniques such as 3-D bioprinting to control the final product’s nutritional content, including the specific ratio of fat to muscle in the final product. Companies such as Steakholder FoodsFootnote 102 and researchers at Osaka University in JapanFootnote 103 have utilized 3-D bioprinting to produce cultivated steak and wagyu beef with the marbling effect that is often associated with high quality cuts. This ability to control and monitor the production environment aligns with FDA’s aim of improving food quality and safety standards.Footnote 104
C . Promises of Ethical Benefits
For many, one of the most important benefits that cultivated meat offers is the potential to significantly reduce animal suffering.Footnote 105 Conventional meat production inherently involves the slaughter of animals that are often raised in confined spaces and inhumane conditions.Footnote 106 Cultivated meat can be produced without the need to raise, kill, or even harm any animals beyond the initial cell collection.Footnote 107 As such, some cultivated meat products have already been determined to be in accordance with various ethical and religious standards. Three Sharia law scholars determined GOOD Meat’s products can be considered halal;Footnote 108 the Orthodox Union (OU), the largest kosher certification agency, ruled that the products of Israel-based company SuperMeat were considered kosher;Footnote 109 and, although debated, many vegans consider some cultured meat products to be ethically vegan.Footnote 110
The relevant ethical considerations in cultivated meat production are often subjective, but there are strong ethical benefits offered by meat that can be cultivated in a laboratory without harming an animal compared to conventional meat produced via slaughter. Public concern over animal welfare has grown substantially in recent decades,Footnote 111 and cultivated meat may therefore offer an ethically favorable option that would not require people to change their diets. For FDA, supporting the development of cultivated meat is consistent with other recent animal-friendly policy changes such as the FDA Modernization Act 2.0, which promotes alternatives to animal testing and removes required animal testing.Footnote 112
IV. The Reality of Lab-grown Meat
A. Concerns With Safety and Quality
Due in part to the novelty of the concept and the relatively new technology used, cultivated meat has yet to earn widespread trust from consumers. In a poll conducted by the Associated Press-NORC Center for Public Affairs Research, half of U.S. adults said that they are unlikely to try meat grown using cells from animals.Footnote 113 Amy Chen, UPSIDE Foods’ Chief Operating Officer, refers to this phenomenon as the “ick factor.”Footnote 114 When asked for their reasoning, forty-eight percent of respondents said they “don’t think it would be safe” and fifty-six percent said “it just sounds weird.”Footnote 115
Although this reluctance appears to be more due to sentiment than science, there are in fact several potential health hazards that should be addressed before recognizing any cultivated meat products as safe. A 2019 analysis by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) produced an exhaustive list of fifty-three potential health hazards relevant to cultivated meat.Footnote 116 It is important to note a distinction between health hazards and health risks.Footnote 117 Further, the hazards identified were not inherent nor unique to cultivated meat.Footnote 118
The potential hazards identified can be generally grouped into concerns with the identity and source of cells, the introduction of contaminants, and the composition of the final product.Footnote 119 FDA’s review of GOOD Meat’s and UPSIDE Foods’ cultivated chicken products directly addressed these areas of concern and concluded that, “We have no questions at this time about … cultured chicken cell material resulting from the production process defined … are as safe as comparable foods produced by other methods.”Footnote 120
1. Genetically Modified Cells
The use of genetically modified animals has been approved and is currently used in conventional meat production today.Footnote 121 While companies like GOOD Meat have stated that they only use cells from unmodified chickens,Footnote 122 it is foreseeable that other companies may use genetically modified animal cells. In a similar vein, some cultivated meat companies, such as UPSIDE Foods, have used genetic modification of cell lines to improve the ability of the cells to be cultivated.Footnote 123 Concerns have been raised regarding the potential hazards associated with the use of genetically modified cells. The fear is that these cells may alter their gene expression significantly, which could potentially lead to harmful substances being present in the cells and in the final product.Footnote 124
However, the risk posed by genetically modified cells is minimal. For there to be a risk of harm, the gene expression of the cell lines used must be substantially altered, which there was no indication of in the GOOD Meat or UPSIDE Foods cell lines.Footnote 125 If the cell lines were altered, the genetic alteration must theoretically be such that the cells produce novel substances and that these substances prove toxic. These toxic substances would have to remain undetected through all stages of the safety assessment of the animal, the biopsy of the cells, and the cell selection. The toxic substances would have to survive through the cell culturing without disrupting the delicate process, without being degraded or removed, and once again without being detected. Finally, the toxic substance would need to remain undetected in the final stages of harvesting yet still be present at levels hazardous to consumers.Footnote 126 Given the unlikely nature of such a scenario, there is very little risk of genetically modified cells resulting in any harm — this is supported by the findings of the UN FAO, WHO, and FDA in their reviews of cultivated meat products.Footnote 127
2. Adventitious Agents and Contaminants
Although not unique to cultivated meat, the introduction of physical, chemical, or biological contaminants is a major potential hazard in food production.Footnote 128 The risks of these contaminants can include simple risks of physical harm to the mouth, teeth, or gums due to physical hazards, such as equipment or packaging materials.Footnote 129 The risks may also include risks associated with drugs, microbial toxins, antimicrobials, or other contaminants creating hazards to consumers.Footnote 130 There are risks of contaminants being introduced at any stage of production,Footnote 131 which is why strictly following relevant good practices is crucial in any food production process, but especially so in the case of cultivated meat. Nevertheless, accidents do happen, thus rigorous testing at each stage of production is also necessary to detect any adventitious agents. An assessment of these testing processes was a crucial part of FDA’s review of GOOD Meat and UPSIDE Foods.Footnote 132 There was no substance identified that raised concerns regarding their production practices or ability to detect unwanted contaminants.Footnote 133
3. Rapid Cell Multiplication
One concern raised by some critics, which has gained a certain level of popularity in the pressFootnote 134 and in social media,Footnote 135 is a fear that the use of immortalized cells in the production process could lead to harm through tumor formation. In other words, some have claimed that cultivated meat is made from cancerous cells or otherwise may significantly increase risks of cancer. The fear is based on the immortalization of cells, the rapid cell replication process necessary for cultivated meat production.Footnote 136
Immortalization is a process used both in medical researchFootnote 137 and in the production of cultivated meat to enable cells to divide beyond their natural limit — but this alone does not make such cells cancerous. According to one expert asked to debunk the myth: “[a]ll cancers are immortalized, but not all immortalized cells are cancer.”Footnote 138 The current literature suggests that there is no risk related to the use of these cells,Footnote 139 but given the novelty and limited availability, there are very few long-term studies related to the health effects of consuming cultivated meat. Nevertheless, most experts agree the risk is extremely low. Per the FAO:
“For [tumor formation] to happen, all of the following events would need to occur. First, the cells would need to be capable of remaining alive for an extended period after being removed from the environment of the bioreactor that provides a steady supply of nutrients, dissolved oxygen, and a fixed temperature. The cells would also need to survive actively adverse conditions during a series of steps following harvest. These would typically include conventional food processing, handling, and storage at cold or freezing temperatures, and consumer preparation including thermal cooking. A hypothetical cell that survived these steps and remained alive in the final food product would then need to survive gastrointestinal digestion, cross the gastrointestinal barrier layer intact, enter into the blood circulation, evade immune surveillance and attack in the body in spite of being from a non-human species, and finally proliferate in the body.”Footnote 140
Although long term studies are not yet available, there is little evidence available to suggest any notable safety concerns with the production or consumption of cultivated meat beyond the concerns found in conventional meat. Nevertheless, misunderstanding and misinformation will likely be a persistent source of distrust of these products. The cultivated meat industry must focus on education and transparency in their production processes to help align public perception with reality.
B. Unproven Benefits and Production Limitations
A relevant and related set of concerns with the development of this technology and this industry is that many of the benefits described above have yet to be successful at any significant scale. Currently, production levels of the entire cultivated meat industry combined are far from matching the current demand for meat or the current production rates of conventional meat. UPSIDE Foods has invested in a new production facility that may increase their total yearly production rates to as much as thirty million pounds of meat per year.Footnote 141 For reference, conventional chicken production produced over fifty-nine billion pounds of meat in 2022,Footnote 142 nearly two thousand times more than UPSIDE hopes to produce by 2025. Because production rates are insufficient to meet demand, it is yet to be seen if the promised benefits can be maintained as production scales up.
There are also concerns related to the purported environmental benefits of cultivated meat. Critics point out that the current production methods are already energy intensive.Footnote 143 While energy expenditures generally remain below levels required for equivalent conventional meat production, the energy requirements in the theoretical future where cultivated meat outpaces conventional meat may need to rely on unsustainable sources of energy such as fossil fuels.Footnote 144 The findings of a new study from the University of California, Davis contradict the findings of many other studies and suggest cultivated meat could be up to twenty-five times worse for the environment than pasture-raised cattle.Footnote 145 As cultivated meat scales, or attempts to scale, the impacts on the environment must be monitored closely to ascertain the validity of the claims made by both proponents and opponents.
V. Cultivated Meat and Current Regulations
A . FDA and USDA Strategic Joint Approach to Regulation
Determining what regulatory body should have jurisdiction over the regulation of cultivated meat is difficult, as cultivated meat crosses into the regulatory jurisdiction of multiple agencies. The production processes behind the cell cultivation and procurement lend more toward the expertise at FDA, but the final product — aiming to be meat sold for human consumption — falls under USDA’s area of expertise. In the case of cultivated meat, we have seen a refreshingly rational and strategic approach to this potential conflict: in 2019, FDA and USDA came to a formal agreement regarding the oversight of cultivated meat products.Footnote 146 As part of the agreement, each agency identified specific parts of the cultivated meat production process over which they will maintain jurisdiction and regulatory oversight.Footnote 147
1. FDA’s Role in Cultivated Meat Regulation
FDA oversees early stages in the production process.Footnote 148 This includes cell collection, cell banking, cell proliferation, and the differentiation of the cells.Footnote 149 The agency conducts comprehensive reviews on the sourcing of the cells, the sanitation and safety procedures implemented during these early stages, and the testing that is conducted to ensure the quality of the product.Footnote 150
A main focus area for FDA is ensuring that contaminants and adventitious agents are not present in the final product.Footnote 151 FDA also performs thorough inspections of the facilities where the cells are cultured, grown, and harvested and has discretionary authority to conduct further inspections or to impose additional requirements on the facilities responsible for these early stages.Footnote 152 At harvest, FDA helps to coordinate a seamless transfer of regulatory oversight to the USDA Food Safety and Inspection Services (“USDA-FSIS”).Footnote 153
Regulatory oversight by FDA is unique because conventional meat production processes are almost entirely under the authority of USDA-FSIS.Footnote 154 Yet FDA’s regulatory authority over cultivated meat is both important and necessary. FDA has more relevant experience with the regulation of these types of facilities and is better suited to ensure compliance with safety and sanitation standards than USDA.Footnote 155 Furthermore, these early stages of the cultivated meat production process require strict compliance with standards and procedures to consistently produce quality products. Non-sterile seed cells, the introduction of contaminants, or presence of viral agents would be detrimental to the quality of the final product and may cause entire production runs to fail.Footnote 156 FDA’s role here is twofold: their primary concern is ensuring public safety and safe products, and their regulatory oversight also inherently helps ensure consistency and quality for cultivated meat producers. Thus, FDA is expected to play a significant role in the long-term success of this industry.
2. USDA-FSIS Role in Cultivated Meat Regulation
For USDA, regulatory oversight is conducted via USDA-FSIS.Footnote 157 During the harvest stage immediately following transfer of oversight from FDA, USDA-FSIS conducts a thorough inspection equivalent to the inspection conducted on any other meat product bearing the USDA mark of inspection.Footnote 158 The agency reviews necessary information on the harvested cells to determine if they are eligible to be processed into meat products.Footnote 159 Upon grant of eligibility, these cultivated meat products will bear the same USDA mark of inspection as conventional meat products.Footnote 160
USDA has regulatory authority over the labeling of these cultivated meat products,Footnote 161 but specific requirements remain unclear at this time. USDA is also responsible for conducting inspections of the facilities in which these products are harvested, processed, packed, and labeled.Footnote 162 Cultivated meat products and facilities must meet the standards imposed by the Federal Meat Inspection Act,Footnote 163 the Poultry Products Inspection Act,Footnote 164 and the Egg Products Inspection Act.Footnote 165
These facilities must also comply with all Hazard Analysis Critical Control Point (“HACCP”) verification, appropriate production testing, and record reviews.Footnote 166 These standards are mostly comparable to the standards USDA requires for conventional meat production. However, the considerations of the regulatory inspections and reviews differ slightly due to the inherent differences between the production processes. Once cultivated meat products comply with the necessary USDA standards and receive the mark of inspection, the products are then regulated and treated no differently than conventional meat with regard to requirements for storage, transportation, and shelf-life.Footnote 167
The joint approach between FDA and USDA appears to be a well-reasoned and innovative approach to regulating an otherwise difficult-to-regulate novel product. However, not all agree with this assessment. Some scholars, like Tammi Etheridge, have suggested that USDA’s role in cultivated meat regulation is inappropriate and unnecessary.Footnote 168 Etheridge argues that the inclusion of USDA in cultivated meat’s regulation is unnecessary due to the cell-culturing process being more applicable to FDA’s expertise, as the process has much more in common with drug development than conventional meat processing.Footnote 169 While USDA’s role may not be completely necessary, their expertise in handling meat post-processing can and should be utilized, which is essentially the procedure under the current joint agreement.Footnote 170 Etheridge’s argument for FDA to have sole authority of the regulation would thus place significant obligations on FDA in realms where USDA has greater relevant experience in regulating.
The argument for USDA’s inappropriateness is based on an understandable fear that USDA will prioritize the interests of the conventional meat industry over the cultivated meat industry if forced to choose between the two,Footnote 171 as well as a concern that USDA will prioritize its mandate of supporting industry over its mandate to promote nutrition.Footnote 172 Etheridge argues that USDA has already put industry interests over public interests in the case of milk, citing to times when USDA recommended that Americans avoid dairy products while simultaneously pushing the “Got Milk?” campaign to sell surplus dairy products purchased from farmers.Footnote 173 Etheridge raises concerns that USDA will operate in bad faith when it comes to deciding the labeling requirements for cultivated meat.Footnote 174 That said, USDA did not interfere with or delay the approvals of GOOD Meat and UPSIDE Foods.
Though the joint approach to regulation may not be explicitly necessary, it does not yet feel appropriate to extricate USDA from the regulation of cultivated meat products. USDA and FDA have a long history of overlaps in food regulation, and agencies often split regulation of products such as soup or sandwiches without issues.Footnote 175 The mutually agreed-upon guidelines and framework in the joint agreement adequately address the unique nuances of regulating cultivated meat products while simultaneously acknowledging each agency’s strengths and weaknesses. This regulatory approach, although more stringent in some ways when compared to regulation of conventional meat, should ensure safe and reliable food. As cultivated meat progresses, ongoing coordination between these regulatory bodies will be essential in ensuring safety, transparency, and public trust. The benefits of this joint approach can be seen through a review of FDA and USDA’s approval processes for GOOD Meat and UPSIDE Foods for sale to U.S. consumers.
B. Difficulties with Regulation of Cultivated Meat
1. Classification
The development of cultivated meat poses unique challenges for FDA and USDA when it comes to deciding who should regulate it and how. A major initial hurdle is the difficulty in classifying cultivated meat under currently available definitions. While cultivated meat is appropriately considered “food” under the definition provided in Section 201 of the federal Food, Drug, and Cosmetic Act,Footnote 176 it does not neatly fit into any of the existing subcategories of food.
Cultivated meat should not be regulated under the FDA’s Generally Recognized as Safe (“GRAS”) process. Classification of products as GRAS is most typically used for food additives rather than food products and would subject cultivated meat to less stringent regulatory review.Footnote 177 An independent panel of experts could theoretically determine that cultivated meat products are safe and award a GRAS classification, which could then allow for cultivated meat producers to circumvent pre-market review.Footnote 178 But due to the potential for hazards in the production processes, the lack of long-term studies available, and the current public sentiment surrounding these products,Footnote 179 classification of cultivated meat as GRAS is likely not a viable strategy. Further, GRAS status would likely require FDA to take more authority, if not sole authority, over this industry.Footnote 180 While some authors have suggested GRAS classification for cultivated meat, they typically also suggest that FDA should have complete control over cellular agriculture.Footnote 181
Importantly, such a regulatory regime would run contrary to FDA and USDA’s agreement on regulating cultivated meat and would drastically increase FDA’s obligations in their oversight of food products — oversight which is already hampered by understaffing and underfunding.Footnote 182 Less attention and resources within FDA are devoted to food safety, though more has been allocated for the fiscal year 2024 and 2025 FDA budgets.Footnote 183 Of the $22 billion USDA budget for 2025, $1.24 billion is allocated to the Food Safety and Inspection Service (“USDA-FSIS”).Footnote 184 Taken together, FDA and USDA resources make joint regulation a better option—at least in the short-term.
Further, cultured meat does not match FDA’s definition of “meat,” as it is not grown or produced from “[t]he edible part of the muscle of an animal.”Footnote 185 “Meat by-product” is a similarly unfit descriptor, as cultivated meat is not “derived or prepared in whole or in substantial and definite part, from any portion of any animal.”Footnote 186 FDA could consider the cells taken to begin cultivation to fit within the “substantial and definite part” requirement, but the definitional fit is not ideal. Discussion of these definitions and their relation to cultivated meat is more aptly described by Jennifer Penn’s analysis of regulation strategies for lab-grown meat.Footnote 187
Ultimately, attempting to force cultivated meat into one of these existing definitions may lead to more difficulties in regulating it. While this paper does argue, contrary to some prior literature,Footnote 188 that the final product produced by the cultivation process is meat rather than a meat alternative, a new category of food classification must still be created and defined for these types of products to be properly regulated. A suggestion for a better classification and definition of this new type of product is discussed more thoroughly in the Policy Recommendations section of this paper.Footnote 189
2. Labeling
USDA-FSIS has proposed new requirements for the labeling of cultivated meat products. The proposed rules call for the “display [of] unique labeling terminology that enables consumers to accurately identify the nature and source of such products.”Footnote 190 However, the exact requirements are not yet clear, and the rule has not yet been finalized.
As referenced earlier, some have expressed serious concern with USDA’s oversight and control over the labeling of cultivated meat.Footnote 191 USDA has developed a reputation for serving the animal agriculture industry,Footnote 192 causing some to suggest that USDA would not act in good faith in regulating the labeling of cultivated meat.Footnote 193
Others have insisted upon distinctive labels for lab-grown meat that would alert consumers to the “true nature” of those products. In 2018 — five years before the GOOD Meat and UPSIDE Foods approvals — the state of Missouri passed a law requiring special labels for lab-grown meat.Footnote 194 Since then, several states have followed suit, including Alabama, Arkansas, Georgia, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, North Dakota, Oklahoma, South Carolina, South Dakota, Texas, and Wyoming.Footnote 195 In 2024, a Missouri district court upheld the state’s labeling law against a challenge from plant-based meat producer Tofurky.Footnote 196
While this paper takes the position that cultivated meat is meat, there is understandable resistance to the labeling of cultivated meat products as merely “meat” without qualification. People may have multiple reasons to want to avoid cultivated meat products and should have the right to be informed that a product is cultivated if desired. The current approach for cultivated meat producers has been to draw a deliberate distinction between their products and conventional meat products. GOOD Meat proposed a label of “Cultured Chicken” for their products in their dossier in support of the safety of their product.Footnote 197 However, past mandatory labeling requirements have been found to be in violation of the First Amendment, such as the labeling requirement at issue in the case of International Dairy Foods Association v. Amestoy. Footnote 198 Similarly, in a more recent case, a federal district court enjoined the enforcement of Arkansas’ restrictive labeling laws prohibiting the use of “meat” terminology for plant-based or cultivated meat products.Footnote 199 Labeling requirements for cultivated meat must be carefully considered. Requirements which are too lax may cause consumer confusion, while overly strict requirements could raise questions about compelled speech and may detrimentally impact the business interests of cultivated meat companies.
As discussed in Legalizing the Meaning of Meat, a review of meat alternative labeling laws, there is a mix of legislative opinions on the labeling of any meat replacement or alternative.Footnote 200 However, consumers who enjoy the taste, nutritional makeup, and caloric density of meat may still have a variety of vastly different feelings about different “meats.” All else being equal, one consumer can have valid reasons to avoid a burger produced via animal slaughter, while others may wish to have a burger produced the traditional way or to avoid burgers produced using insects or plants.
A burger is merely the shape of the chosen product. Meat replacements should be required to use certain qualifiers to distinguish their products but should not be banned from using common food terms. The regulatory line between consumer protection and government restriction on economic speech must be carefully drawn. As Steph Tai notes, “to limit or compel certain food labels, regulators must either establish that certain labels are misleading in some way, or craft requirements that advance a substantial state interest in a manner that directly advances that interest without being more restrictive than necessary.”Footnote 201 The relevant four-part Supreme Court test was established in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York:
“In this test, courts must evaluate (1) whether the speech is unlawful or misleading, (2) whether there is “a substantial interest to be achieved by restrictions on commercial speech,” (3) whether the restriction “directly advance[s] the state interest involved,” and (4) whether “the governmental interest could be served as well by a more limited restriction on commercial speech…”Footnote 202
Labeling of cultivated meat is thus a crucial aspect of the regulatory approach and must be carefully considered so that both consumer and business interests are adequately protected. However, like the varied approaches to the labeling of meat alternatives, there is a growing regulatory split among several states related to whether cultivated meat may be produced or sold at all, notwithstanding the existence of federal regulations allowing their sale.
3. Politicization of Cultivated Meat
In the United States, there is an alarming trend of states introducing bills to restrict the sale and production of cultivated meat products. Some of these bills focus mostly on strict labeling requirements. As described in the previous section, labeling of cultivated meat is an important consideration. While overly strict labeling requirements may not be good for the industry, they may be justified somewhat by understandable policy goals to protect consumers from an unproven product. However, the legislative trend spreading across the states goes well beyond any reasonable policy goals. Several of these bills intend to completely ban cultivated meat products, and a few criminalize the production or sale of cultivated meat.
One of the first of these bills was signed into law in May 2024 by Florida Governor Ron DeSantis. Florida’s new law makes it a criminal offense to sell or produce cultivated meat in the state.Footnote 203 A week later, Alabama Governor Kay Ivey signed a similar bill prohibiting the manufacture, sale, or distribution of cultivated meat products in the state.Footnote 204 Since then, laws have been signed or bills have been introduced in several more states to ban, not regulate, cultivated meat. So far, these include but will likely not be limited to: ColoradoFootnote 205, IllinoisFootnote 206, IowaFootnote 207, MississippiFootnote 208, MissouriFootnote 209, NebraskaFootnote 210, North DakotaFootnote 211, OklahomaFootnote 212, South DakotaFootnote 213, and TexasFootnote 214. By stark contrast, California in 2022 became the first State to support cultivated meat, investing five million dollars into its research and development.Footnote 215 Of note, both GOOD Meat and UPSIDE Foods are headquartered in California.Footnote 216
Generally, the driving force behind cultivated meat bans is a perceived need to ensure consumer safety and the product safety of cultivated meat.Footnote 217 Critics like Florida State Senator Tina Polsky argue that such measures mischaracterize cellular agriculture as a threat to conventional agriculture, dubbing it a “political boogeyman.”Footnote 218 Some have suggested these bans are merely motivated by political partisanship rather than consumer protection or constituent demand.Footnote 219 Others have suggested that lobbying from the farm industry was a primary driver of the legislation.Footnote 220 Notably, Florida’s bill was strongly supported by the Florida Farm Bureau, the Florida Poultry Federation, and the Florida Cattlemen’s Association.Footnote 221
The majority of politicians pushing for state-based labeling requirements and product bans are Republicans,Footnote 222 and there are some politicians who have pushed for banning cultivated meat products for less legitimate reasons. For example, Florida State Representative Tyler Sirois claimed cultivated meat products are an “affront to nature and creation” and are part of the “ESG agenda,”Footnote 223 alluding to environmental, social, and corporate governance reporting requirements promulgated by the United States Securities and Exchange Commission.Footnote 224
Nevertheless, cultivated meat may raise legitimate concerns for states whose economies depend significantly on animal agriculture. The text of a bill introduced in Arizona to ban cultivated meat contains a provision stating that “cattle are one of the five foundational pillars that have driven Arizona’s economy since territorial days” and that “the production and sale of lab-grown, cell-cultured animal product threatens to harm Arizona’s trust land beneficiaries and the highest and best use of state trust land.”Footnote 225 This memorializes in writing the fears coming from the animal agriculture industry and those connected to it.
The cultivated meat industry could challenge the conventional meat industry in a big way, which could lead to substantial economic consequences. Whether these consequences are good or bad for the greater economy depends heavily on how these products are regulated. In the event that cultivated meat advances to the level many are hoping for, the animal agriculture industry and the states whose economies rely on it may need to adapt quickly to avoid major economic harm. While regulators should plan for the potential economic consequences of cultivated meat’s development, an outright ban is reactionary. The success of cultivated meat does not equate to an economic disaster for states or industries. Most cultivated meat companies — although often based on values of helping the environment, health, or animals — are seeking to be profitable.Footnote 226 The profit potential for cultivated meat seems apparent when considering the several conventional meat industry leaders who have invested in cultivated meat’s development, such as: Tyson, JBS and Cargill.Footnote 227 There is ample opportunity for cultivated meat to create jobs and other economic benefits, even for states that now heavily depend on animal agriculture.
Cultivated meat has sparked a political debate on the safety of the products, the potential economic impacts, and its place in our culture. Proponents of cultivated meat, including UPSIDE Foods, assert that cultivated meat products are safe and are already subject to rigorous regulatory processes by federal agencies.Footnote 228 They argue that cultivated meat is an innovative solution that can complement conventional meat production while also addressing ethical concerns and environmental challenges.Footnote 229 Some research suggests that the cultivated meat industry may have positive impacts on the economy and can create new jobs.Footnote 230 Nevertheless, critics remain focused on the unproven benefits, the potential for economic harm, and the potential for negative social or cultural impacts.
While regulation is necessary, outright bans on cultivated meat, especially on its research and development, are cause for alarm. This approach to regulation risks unnecessary delays or complete blockades to scientific advancements which may provide substantial benefits to all. As discussed in subsequent sections of this article, cultivated meat is safe and can be regulated in a way that ensures its safety. By pre-emptively banning, or criminalizing, an entire industry without good cause, these laws are offensive to the ideas of free market, scientific development, and consumer freedom. Only time will tell if cultivated meat can live up to the many promises the industry has made, however these bans, if successful, will do nothing but unnecessarily remove potentially beneficial markets from our grocery stores.
VI. The Approvals Heard ‘Round the World
The recent approvals for sale to U.S. consumers for GOOD Meat and UPSIDE Foods by FDA and USDAFootnote 231 represent a major historical milestone for cellular agriculture and the cultivated meat industry. These approvals are acknowledgments of the safety of these products and may help to spark global development of the industry. A global explosion in discussion, interest, investment, and research of the technology and these products has followed FDA and USDA approvals. The following sections explore the considerations behind each company’s approval and explain some of the stringent safety measures these companies have implemented.
A . FDA and USDA Approvals
Both GOOD Meat and UPSIDE Foods had to navigate a complex regulatory landscape to secure FDA and USDA approvals for the sale of their cultivated chicken products in the United States. Although this is a major victory for these companies and the industry as a whole, there is still significant work to be done. Notably, these approvals are not general approvals for the companies but are instead approvals of one specific product that the companies sell. For each new product that these companies cultivate and wish to sell, they will be required to navigate the complex and lengthy process again to certify that each and every product they plan to sell is safe for human consumption.
1. Analysis of Production Processes and Safety Measures
While the products both companies obtained approval for are chicken products cultured from Gallus gallus cell material (chicken cells), their production processes and the specifics of their products differ slightly. Both companies implement rigorous safety measures throughout their production processes.Footnote 232 Both companies utilize manufacturing programs consistent with Federal Current Good Manufacturing Practice:Footnote 233 traceability of raw materials and finished products; batch record review; a product release system; environmental sanitation and monitoring program; and hazard control and prevention plans.Footnote 234 Some of the main considerations for FDA in reviewing these companies’ products are the source of the animal cells, the environmental controls, the identification of potential contamination risks and plans to mitigate, the use of testing throughout all stages of production, and the information the companies relied upon to conclude that their products are safe.Footnote 235
One key focus of review was the cell culture media used to grow the products.Footnote 236 These media provide the cells with the nutrients necessary to survive and grow.Footnote 237 The specifics of the media used are a relevant consideration in determining the risk of unintended and/or unsafe contaminants. Both companies use their own formulation of a basal medium, which includes amino acids, vitamins, salts, antioxidants, and other nutritional components.Footnote 238 Although both companies kept their exact formulas confidential, they provided FDA with the full detailed list of the substances used.Footnote 239 In FDA’s memorandums to the companies, they affirm the companies’ conclusions that the ingredients in the media used are largely removed from the final product during a washing phase and that all are substances commonly found in food.Footnote 240
The companies’ successful regulatory compliance and the subsequent approval of GOOD Meat’s and UPSIDE Foods’ products are due in large part to close interactions with FDA for several years prior to these approvals.Footnote 241 FDA strongly encourages other companies seeking approval for sale in the United States to begin engaging with regulators very early in their product development timeline and to maintain high levels of engagement throughout development.Footnote 242 GOOD Meat and UPSIDE Foods have both committed to meeting and exceeding safety and quality standards, though a recent story in WIRED titled Insiders Reveal Major Problems at Lab-Grown-Meat Startup Upside Foods may tell a different story.Footnote 243
2. Impact of Approval
The approval for these companies to sell to U.S. consumers has had and will have major effects for these companies. Primarily, this allows them to begin profiting from their products in the highly sought-after U.S. market, incentivizing them to make these products more affordable and to expand production within the United States. Following regulatory approval of its product, GOOD Meat announced that they immediately began production of the first batches of cultivated chicken, which will be made available in more than 30 locations across the country.Footnote 244 Meanwhile, UPSIDE Foods began increasing their investments in development and are building a new production facility in Illinois to massively increase their production capacity.Footnote 245
This demonstrates the immense power that FDA and USDA hold over this industry. Approval for sale, especially in the early days of this burgeoning industry, can dramatically change the strategy and potential for success for a cultivated meat producer. FDA must recognize this and wield its regulatory authority in a way that meaningfully advances the industry. While regulation thus far has been well implemented, there is still much progress that can be made through carefully considered industry guidance documents and other policies.
VII. Policy Recommendations
A. New Regulatory Definition for Cultivated Meat
A seemingly insignificant but potentially very important consideration that should be addressed before further decisions are made related to the regulation of cultivated meat is the establishment of a mutually agreed-upon definition of what is, and what is not, cultivated meat. Given issues related to the classification and labeling requirements of cultivated meat, some state governments have already attempted to regulate cultivated meat.Footnote 246 One trend observed in some of these regulation attempts is the confusion or conflation of cultivated meat with plant-based meat.Footnote 247 These are completely different products, and a clear definition for cultivated meat that draws a distinction between these products will help with regulation.
Additionally, as cultivated meat gains popularity, it is not unreasonable to see how a plant-based meat producer may wish to portray their product as cultivated meat. A standard regulatory definition will also help prevent this from occurring. The formal agreement for regulation between FDA and USDA offers the clearest effort at a regulatory definition: “human food produced using animal cell culture technology derived from cell lines of USDA-amenable species.”Footnote 248 While this definition is serviceable, an improved one should be considered as these products are likely here to stay.
Our proposal for a broader definition of cultivated meat is as follows:
“Cultured Meat” or “Cultivated Meat” refers to animal-originated tissue products that have been grown or cultured from animal cells in a controlled environment, outside of the traditional animal husbandry context, for the purpose of food or food products for human consumption that resemble meat or meat food products (as defined by 9 C.F.R. § 301.2). This production process involves the use of cell culture technology, including, but not limited to, cell line selection and maintenance, cell proliferation, tissue engineering, and bioreactor cultivation.
Adopting this or a similar definition would be a forward-thinking step that would prepare FDA, USDA, and any other relevant agencies for the rapidly developing nature of this technology. This definition, or any similarly specific definition for these types of products, will ensure that regulatory frameworks remain relevant and effective.
B. Strict Regulatory Framework for Cultivated Meat Facilities
FDA, in collaboration with USDA, must adopt a strict and comprehensive regulatory framework with the primary purpose of safeguarding public health and enhancing consumer confidence in cultivated meat products. Our proposed framework, discussed in detail below, requires intense review of cell line selection and maintenance, frequent testing of master and working cell banks, stringent aseptic techniques and contamination control at each stage of the production process and for any equipment used, and strictly monitored and controlled cleanroom environments.
Well-defined standards for growth media and raw materials are also vital. Such standards would ideally require that all inputs meet safety and quality benchmarks, as verified by continuous testing. The use of both regular and random testing for contaminants must be implemented to ensure consistent product safety. Generally, the regulatory framework should match the standards that are required for biopharmaceutical productions. The standards used by both GOOD Meat and UPSIDE Foods, detailed in their respective submissions to FDA,Footnote 249 represent good models for such regulatory requirements.
While outside of FDA’s current regulatory scope,Footnote 250 the framework must also include efficient harvesting and washing techniques. Standards should be defined for what materials and substances are appropriate to use for washing. Thorough analysis, testing, and review of the final products is necessary. Current regulations under USDA at the harvest stage are comparable to the standards for conventional meat.Footnote 251 While these standards are adequate, higher standards for review would not overburden the industry due to the inherently high standards required for quality production. This may help with public trust and perception while avoiding any concerns arising from USDA’s reputation for relaxed standards in their inspections of meat production facilities.Footnote 252
Furthermore, at every stage of production, it is crucial to ensure that company personnel are all adequately trained in aseptic techniques, safety protocols, and emergency procedures, with training programs regularly updated to reflect current best practices and technological advancements. This is largely in line with the current standards.Footnote 253 However, the rapid development of this industry requires a particular focus on maintaining updated standards. As an example, only a few years have passed since the publication of Etheridge’s article What’s The Beef? The FDA, USDA, and Cell-Cultured Meat,Footnote 254 but many of the safety concerns cited throughout the piece are less relevant to current manufacturing practices. Several companies are moving away from the use of artificial food coloringFootnote 255 and fetal bovine serum,Footnote 256 and antibiotics and fungicides which were previously required to avoid contamination are not used by several companies today.Footnote 257
Ideally, a general policy would demand continuous improvement and encourage routine internal and external inspections. Cultivation processes across the industry should be regularly reviewed for the purpose of updating processes and procedures based on new scientific findings, technological improvements, and regulatory changes. Finally, FDA and USDA should be prepared and willing to strictly enforce recalls or closures of production facilities.
This comprehensive and stringent regulatory framework, while ensuring product safety and quality, would also promote continuous improvement and innovation in the cultivated meat industry. These frameworks will help shift public perceptions of these products as well as promote safe and sustainable development of the industry.
C. Streamlined Approval Processes
The above-outlined regulatory framework requires high levels of compliance and adherence to strict guidelines. These frameworks may appear to be somewhat burdensome to the industry. However, as mentioned previously, the production process of cultivated meat inherently requires adherence to strict guidelines. As evidence of this, one could review the Standard Operating Procedures (SOPs) implemented by JOINN Biologics, the company contracted to perform GOOD Meat’s cell culturing processes.Footnote 258 These SOPs are very strict by design, emphasizing that any contaminants, unintended substances, or variation from the cultivation process would “negatively affect the production capacity of the cell culture system” and may cause a production run to completely fail.Footnote 259 Thus, the implementation of the above-proposed guidelines and strictly enforced adherence to them should not burden these companies or this industry.
1. Benefits of Streamlined Approval
Given the extremely sensitive nature of the biochemical production process,Footnote 260 cultivated meat producers inherently must comply with their own strict protocols without regard to what regulations are imposed, FDA and USDA could develop policies and strategies that expedite the approval process to encourage and promote development of the industry. As seen in the examples of GOOD Meat and UPSIDE Foods, approval led directly to increased production and investment. A streamlined approval process that still requires companies and producers to meet the frameworks outlined above will allow U.S. consumers to enjoy the many benefits of cultivated meat much sooner while simultaneously promoting several of the pragmatic and self-serving interests of the general public, FDA, and USDA.
2. What a Streamlined Process May Look Like
The development and implementation of a streamlined approval process for high-quality cultivated meat products must prioritize both industry innovation and unwavering commitment to public health and safety. The successful implementation of a streamlined process will depend heavily on several regulatory decisions that must be made by FDA, USDA, Congress, and state governments related to the regulation of the industry, such as the clear regulatory definition described earlier.
The following are some suggested strategies and policies for FDA and USDA that may help to facilitate the regulatory approval process for cultivated meat producers to receive clearance to sell their products in the United States. Given the uncertain legal and political landscape currently surrounding cultivated meat,Footnote 261 these suggestions will likely need consistent refinement and review as new state and federal regulations are developed and implemented.
a . Inspectors and Accreditation Bodies
By embracing a framework akin to FDA’s Accredited Third-Party Certification Program, the regulatory agencies could strategically engage esteemed third-party organizations to perform thorough audits and evaluations of cultivated meat production operations.Footnote 262 This approach would improve FDA and USDA’s regulatory reach, ensuring that production facilities uphold the rigorous safety standards necessary for consumer protection while minimizing costs related to the inspections. To safeguard the credibility and reliability of this process, it is crucial that the third-party entities are carefully selected and continuously scrutinized to preserve the integrity of the approval process. By utilizing third-party inspectors and accreditation bodies, FDA and USDA could focus their time and resources on overseeing a select group of trusted specialists rather than attempting to monitor each individual cultivation facility.
Considering the already understaffed and underfunded nature of FDA,Footnote 263 USDA inspectors could be appointed to meet the need for cultivated meat inspections. Under the Federal Meat Inspection Act, the Secretary of Agriculture has authority to appoint inspectors to enter into and examine “establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce.”Footnote 264 Additionally, USDA regularly places its own FSIS inspectors in meat processing plants to identify potential food safety risks.Footnote 265 This is one clear benefit of the joint approach taken by FDA and USDA. However, “[u]nlike the FDA’s inspections, which seek to determine compliance, the USDA takes a stricter, constant-presence approach.”Footnote 266 Importantly, FDA and USDA inspection processes are also in need of reform, as discussed in a separate article that points to the Boar’s Head listeria contamination as evidence of a flawed process for meat inspection.Footnote 267 Making USDA-FSIS and FDA inspection reports publicly available provides one opportunity to shame companies into compliance.Footnote 268
b . Standardized Documentation Templates
Inspired by the success of the FDA’s Food Safety Modernization Act (“FSMA”)Footnote 269 in improving food safety, the creation of standardized documentation templates specifically designed for cultivated meat producers could significantly streamline the regulatory submission process. These templates would outline the essential information required from producers in a clear and organized manner, facilitating completion by manufacturers and faster review by regulatory authorities.
Despite standardized documentation, quality and safety standards should still be closely scrutinized to ensure that companies which are not able to meet the highest safety and quality standards do not receive approval. Because many cultivated meat producers already self-impose extremely rigorous quality standards, this approach is likely to aid producers in achieving compliance while also enhancing the efficiency of the approval process and without substantially increasing costs to the industry.
c . Pre-Approval Consultations
Building on FDA’s established processes for early engagement with pharmaceutical entities,Footnote 270 the introduction of pre-approval consultations for cultivated meat producers should also be considered. These types of consultations are designed to serve as forums for helping companies navigate complex regulations. Early engagement also serves as an opportunity for dialogue that not only anticipates and resolves potential regulatory hurdles prior to formal application submissions but also provides producers with a smoother, more efficient review process. By identifying and addressing areas of concern early in the process, this strategy will significantly reduce barriers to approval. This approach will enable producers to be better prepared to pass rigorous regulatory reviews.
d . Digital Compliance and Monitoring Tools
In an increasingly digital world with substantial recent developments in technology, the implementation of sophisticated digital compliance and monitoring tools could redefine the landscape of regulatory oversight. By integrating digital platforms and electronic systems to enable real-time, continuous monitoring, regulatory agencies can maintain detailed and accurate monitoring of production processes. This could reduce the time and resources necessary to conduct in-person reviews without sacrificing quality or safety. This could also improve current compliance monitoring via 24/7 monitoring and recording of the entire production process. For example, a bioreactor could be constantly monitored for contaminants rather than relying only on routine testing of samples.
This approach will depend on the sophistication of the available technology and the willingness of regulatory agencies and industry actors to utilize said technology. Assuming the relevant technology is accessible, this approach could be offered as a voluntary pathway for producers to accelerate their inspection and approval processes. Because this approach would be voluntary, there would not be issues with privacy concerns, as the tradeoff between the privacy interests of cultivated meat producers would be offset by the economic interests of shorter approval times. Additionally, many cultivated meat companies acknowledge the need to be more transparent in their production processes as a way to build public trust in their products,Footnote 271 though commercial secrets (e.g., in basal medium formulation) may be necessary for manufacturers to establish market share.Footnote 272 This strategy ensures that compliance with stringent safety standards is not just a periodic checkpoint, but rather a continuous, integral part of daily operations, enhancing the reliability and safety of cultivated meat products on the market.
Implementation of these strategies requires careful consideration of existing regulations, may require federal legislative action, and will need to be transparent to build and maintain public trust. By engaging in a public consultation process, FDA and USDA can ensure that these streamlined approaches balance the input of consumers, industry experts, and other interested parties to build a strong regulatory framework for cultivated meat.
The success of a streamlined approval process will hinge on its ability to encourage industry growth while maintaining the highest safety standards. As this novel industry evolves, so too must our regulatory approaches, ensuring that they are both effective in protecting public health and conducive to innovation.
VIII. Conclusion
Cultivated meat products represent transformative and potentially revolutionary advancements in food science. Cultivated meat and the technology behind it carries much promise, including environmental, health, and ethical benefits. However, many of these benefits are theoretical and cannot be demonstrated until production rates and development increase substantially. The landmark FDA and USDA approvals of GOOD Meat’s and UPSIDE Foods’ cultivated chicken products were pivotal historical moments for both the cultivated meat industry and the U.S. food sector.
As more companies cultivate new meat products, regulatory frameworks must be thoroughly reviewed and updated. Depending on their actions, FDA and USDA could make or break the success of this industry as a whole. This paper highlights several key aspects to regulation that must be considered to ensure consumer safety, product quality, and sustainable development of this new industrial sector and provides a comprehensive roadmap for navigating the complex, yet promising, landscape of cultivated meat. GOOD Meat and UPSIDE Foods are privileged to be the first companies permitted to sell cultivated meat products to U.S. consumers. Only time, and perhaps FDA and USDA, will determine how many more companies will join them.
