Disruptive innovation in cell-based foods face significant hurdles as regulatory and technological challenges begin to mount

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Credit: Aleph Farms
Credit: Aleph Farms

Of the major markets across the world, the US and EU arguably have the most well-defined regulatory pathways [for implementing cell-cultured meat.] In the EU, the Novel Food Regulation explicitly mentions foods derived from cell and tissue culture and outlines a path to approval that could take as little as 18 months to complete.

In the US, the road ahead is less clear. However, in 2019 the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a joint agreement for the regulatory pathway for meat products derived from cultured cells, other than cultured fish, which is likely to be regulated solely by the FDA. 

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Whether or not cultured meat products contain GMOs (and some suggest that it will be difficult to create a commercially viable product without some form of genetic modification), [Europe’s historic GMO opposition] is perhaps a worrying precedent for companies hoping to release products in the EU.

This is less likely to be an issue in the US, although approval involves interacting with two separate regulatory bodies — the FDA and USDA — which may complicate the process. Each body may have different data requirements and timescales, and the exact roles played by each body are not yet clear. Nevertheless, IDTechEx believes that the US is the more likely of the two regions to see the first approvals of cultured meat.

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