A meaty issue: is the U.S. prepared to place lab-grown meat on the market?

Posted 23 May, 2019

Once again, science has advanced beyond all expectations and has achieved an extraordinary milestone: creating meat without killing an animal. This phenomenon, which is obtained by the in vitro cultivation of animal muscle cells, is commonly referred to as lab-grown meat (or laboratory, clean or cultured meat) and, if all goes to plan, the U.S. may be the first country to legalise and commercialise it.

Definition of ‘meat’

Even though lab-grown meat shares many of the nutritional and physical characteristics with regular farmed meat, it does not fit into the definition of meat and meat products set in CFR Title 9 §301.2 and Title 21 §601(j), respectively.

  • Definition 1 – refers to the muscle of animals with or without bone or fat tissue (Title 9 Animals and animal products).
  • Definition 2 – states that meat products are obtained from animal carcasses (Chapter I of the Title regulating food products: Title 21).

So where does this leave cultured meat?

The development of a new framework will be necessary to avoid creating a disadvantageous market for traditional meat. In an attempt to anticipate the scenario where cultured meat is legalised, the State of Nebraska, has published their Legislative Bill 14 where the term “meat” has been restricted to products derived from livestock. The local authorities aim to give clear advertising guidelines to limit a possible misinterpretation of the definition and product label and protect the identity of (non-cultured) meat products. The impact of cultured meat on the market does not only imply a change in the definition of “meat”, but also the introduction (or modification) of labelling requirements to ensure a clear and reliable identification of such products, in order not to mislead the consumer.

FDA & USDA evaluation

The jurisdiction of these new cultured meat products has been uncertain for some time. While the USDA (and their agency of Food Safety and Inspection Service or FSIS) traditionally takes over the inspection and control of meat products, the FDA is usually responsible for processed meat products. However, how the food sector is split between the FDA and USDA is far more complex and, therefore, this new legal scenario requires an extensive and profound evaluation by the two entities.

The responsibilities and jurisdiction were discussed in a meeting held by the FDA and USDA’s representatives in October 2018. On 7th March 2019, the FDA released a press release where they announced a formal agreement on joining efforts to construct a regulatory framework around cultured meat. In summary, the FDA will be responsible for overseeing the process from cell collection to cell differentiation, and the USDA-FSIS will supervise the next steps of the manufacturing process and product labelling. This decision is aligned with the areas of knowledge and prior experience of each of these two entities as the FDA have already dealt with cell-based ingredients and culture technologies brought through GRAS Notification (e.g. Dried biomass of Chlamydomonas reinhardtii), whereas the USDA-FSIS has broad experience in the correct handling and labelling of meat products.

A positive alternative to traditional meat?

Considering the ethical implications of animal production, this innovative method of producing meat would offer an alternative to the current farming situation. However, it is important to note that the production of lab-grown meat has commonly involved the use of fetal bovine serum (FBS) and other animal-derived products. Nevertheless, some lab-grown producers have claimed that their manufacturing – although relying on products of animal origin – does not involve animal slaughter. The system of enrichment and selection of lab-grown meat is still not optimised and may take years before completely breaking its dependence on animal production.

If it were possible for the growth medium not to be of animal origin, this could be a step towards a more environmentally conscious food chain. Livestock production systems are responsible for 14.5% of greenhouse gas emitted by human activity. Moreover, cattle farming accounts for approximately 65% of those emissions, not to mention that the livestock sector is also one of biggest consumers of natural resources (water, soil, etc.) which can ultimately lead to deforestation and water scarcity (FAO, 2013).

It is still unclear whether an industrial-scale laboratory cultured meat system would have a reduced impact on the environment, though some scientists have pointed out that it could easily drop water and land use by two orders of magnitude (Tuomisto, H. & Roy, A.; 2012). Furthermore, the use of antibiotics will not be needed in the production process, hence a reduction in antibiotic resistance. Lab-grown meat could contribute to food security by producing an animal protein source with shorter production periods and less resources when compared to traditional animal production systems.

Nutritional and safety considerations

If lab-grown meat becomes an alternative to traditional meat, it may not easily replace traditional meat due to its lower nutritional value. While traditional food is produced through in vivo processes in which the metabolism of diverse systems and organs is involved, lab-grown meat is produced by culture growth in an enriched fermentation medium. Thus, many of the metabolic routes present in vivo will not take place in lab-grown meat, suggesting it could be nutritionally disadvantageous when compared to the traditional option. Nevertheless, this unbalanced nutritional profile could be easily addressed by fortifying the product with the missing essential nutrients. Additionally, genetic engineering could be also used to modify the metabolism of cell culture to incorporate genes to further improve the nutritional value of the product.

The safety of this new product has also been questioned. Although a manufacturing process based on cell cultivation may not be attractive to consumers, the lab-grown production system is closer to food processing than to the animal livestock systems (or primary sector). Food safety systems can monitor all safety variables and quality parameters in a more controlled way than animal production. Therefore, the safety degree of lab-grown meat can be compared to that of beverages or ready-to-eat food.


At first glance, lab-grown meat could be a safe and environmentally friendly alternative to traditional meat, especially for the vegetarian and vegan community. For now, the regulatory landscape and manufacturing costs associated with the production of lab-grown meat represent some of the main challenges facing the food industry before “clean meat” becomes a major player in the US and global markets.


  • FDA (2019). “USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry”, Press Announcement, 7 March 2019. Available from: [https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632916.htm];
  • https://www.natlawreview.com (2019). “Nebraska Bill Defines Meat as Derived from Livestock or Poultry”, The National Law Review, 15 January 2019. Available from: [https://www.natlawreview.com/article/nebraska-bill-defines-meat-derived-livestock-or-poultry]
  • USDA. Mandatory meat and poultry production inspection and voluntary inspection and certification: Terminology, adulteration and misbranding standards, C.F.R. Title 9 §301.2 (1970).
  • FDA. Meat inspection: Inspection requirements, adulteration and misbranding. C.F.R. Title 21 §601(2014).
  • FAO (2013). Key facts and findings. Available from: [http://www.fao.org/news/story/es/item/197623/icode]
  • Tuomisto, H. & Roy, A. (2012). Could cultured meat reduce environmental impact of agriculture in Europe? Available from: [https://www.researchgate.net/publication/255179690_Could_cultured_meat_reduce_environmental_impact_of_agriculture_in_Europe]