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The US Approvals: What Do They Mean?

This is a milestone in cell ag’s regulatory history, but we have a long way to go to achieve cultured meat’s mission.

Published June 26, 2023 | Updated June 26, 2023 | Dwayne Holmes

This month, two U.S. companies received approval for both labeling and grants of inspection (GOI) by the USDA, allowing for the sale of their “cell-cultivated meat” products in the US.

This news has stirred excitement as a sign of progress for the field of cellular agriculture (cell ag), which holds great promise to end our dependence on intensive animal agriculture — a broken system that negatively impacts the environment, causes tremendous animal suffering, and denigrates human health.

To many, USDA approval conjures images of a transformed dinner plate, however ubiquitous adoption of cell ag is far from inevitable. And despite the hype, this is a regulatory story, not a technological one.

These approvals represent very real progress for the US’s new regulatory system — created specifically to handle cultured meat  — and a milestone in cell ag’s overall regulatory history. However, this isn’t the end of historical firsts, it’s just the beginning.

And, put simply, they don’t represent technological milestones for the field, or even that these companies are ahead of others from a technological perspective. Neither approval involves the scales of production, cost parity, and sustainability necessary to achieve the “next agricultural revolution”. In fact, contrary to public claims of having achieved culture media free from animal slaughter, at least one approval is for a process that uses fetal bovine serum (FBS), and based on FDA documents that may be true for both! This is a repeat of the playbook used in Singapore, where not-ready-for-primetime products are pushed through a regulatory system for marketing purposes rather than achieving mission goals.

To reach real mission goals – to put a dent in reducing greenhouse gas emissions, to reduce animal suffering, to ensure a just, sustainable transition for all – we need a sober assessment of what lies ahead.

This is a nascent industry trying to solve various complex bioengineering, economic and social challenges – a job that should never be left to industry alone.

As a new technology – spurring the growth of an entirely new industry – novelty is easy to come by. That’s precisely why the oft-cited figure of $5 billion in private sector funding can give the illusion that cell ag has significant resources at its disposal. Yet this funding is divided amongst 150 companies, and only a tiny fraction of cell-ag financial support has been allocated to non profit public research and academia.

What’s more, the future contours of the industry remain opaque: it may become an industry dominated by a relatively small group of private companies or one that is diverse and dynamic. It may be IP-obsessed or open. It may be indifferent to emissions and supply chain issues or it may be values-oriented.

That’s why we changed our mission in 2021 to “maximize the positive impact of cellular agriculture”; not to move blindly ahead. The current trajectory of cellular agriculture is concerning, and the latest International Panel of Experts on Sustainable Food Systems agrees: “…public investment might offer the best pathway to nudge alternative protein production away from corporate capture and toward serving the public good.”

There’s a real chance cellular agriculture will fail – yes, even despite exciting announcements about reaching major markets. And it won’t necessarily be because the science didn’t add up. Even if the technology proves true, cell ag can fail because we didn’t think through ownership, governance, intellectual property or policy… because the transformation of our food system was left to market forces alone.

This is humanity’s second chance at feeding the world in a better way.

Let’s keep the mission central as we continue forging ahead.


About the Authors
Dwayne Holmes is New Harvest's Director of Responsible Research & Innovation - EU