18 Jun 2018 --- The FDA is continually evaluating new areas of food innovation and establishing guidelines on how new technology can safely advance. One such area is the development of products that are intended to resemble conventional meat, poultry and seafood. These “cultured” products are generally made from cells collected from animals that are multiplied using non-traditional food technologies. These technologies could offer specific new opportunities over conventionally developed food products.

The use of animal cell culture technology as a method of food production and manufacturing raises many important considerations from a technical and regulatory perspective. To help foster dialogue regarding these emerging food technologies, and the concerns they raise, the FDA recently announced a public meeting to discuss the opportunities and challenges of this new space to be held on July 12.

Under the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article.” Thus, as a starting point, both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to the FDA’s jurisdiction.

FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram say: “This is a dynamic space that’s gaining interest among companies for various reasons, including appealing to consumers motivated by animal welfare concerns and commercial incentives, including environmental impact, for replacing traditional animal-derived materials for non-animal derived components. At the same time, the technological considerations for these products are complex and evolving.”

A statement from Gottlieb and Abram also reads: “We expect that most or all starter cells for food applications will come from living animals for the foreseeable future for commercial and marketing reasons. While currently, animal cells can be produced from the starter cells in bioreactors (a scaled-up application of traditional cell culture techniques) businesses are also working to commercialize processes by which cells can be cultured using biocompatible scaffolding or other techniques to permit the formation of complex tissues, similar to strategies being explored for therapeutic organ or tissue replacement.”

In either case, a significant technical challenge concerning the use of animal cell culture technology to develop foods intended to resemble conventional meat, poultry and seafood products involves the development of the growth medium used to multiply the cells and ensure that they differentiate into the correct cell types.

“Finally, after creation, both suspension-cultured (unstructured) and scaffold-cultured (structured) products would be further processed using traditional food manufacturing processes that fall under FDA regulations such as the Food Safety Modernization Act’s preventive controls framework,” says Gottlieb and Abram.

The FDA has a long history of ensuring food safety and applying our statutory framework while supporting rapidly evolving areas of technological innovation in food. The agency currently evaluates microbial, algal and fungal cells generated by large-scale culture and used as direct food ingredients. The agency administers safety assessment programs for a broad array of food ingredients, including foods derived from genetically engineered plants, and also manages safety issues associated with cell culture technology in therapeutic settings.

Also, the FDA manages the potential risks associated with the processing, manufacture and packaging of many foods, including most seafood products. The FDA remains committed to using expertise in relevant scientific areas to evaluate the safety of emerging food technologies, such as foods generated by animal cell culture technology. But as mentioned, in addition to leveraging the existing expertise of our staff, the FDA is also investing in making sure they are considering all the unique attributes and challenges of this specific area.

The July 12 meeting will provide an important opportunity for the FDA to share our experiences in evaluating and ensuring the safety of novel technologies in the food sector. The FDA will share our initial thinking for how they intend to appropriately apply our existing regulatory tools and policies to the novel area of technology. The forum will also provide an opportunity to discuss with stakeholders potential benefits and challenges of developing and regulating these products.

“We intend to engage in a public discussion on this evolving technology to ensure we understand and consider all aspects as we determine the FDA’s approach to these novel products.” In addition, Gottlieb and Abram plan to leverage the expertise of the FDA Science Board during their regularly scheduled meeting in October.


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