Cultivated meat approved in the US. Which country is next?

The historic approval, what happens now and the global impact

You’ve surely heard the news: cultivated meat has been approved for sale in the United States.

Everyone from NYT to WSJ and from Fox to Vox covered the story.

The US is not the first country to allow the sale of cultivated meat. That title goes to Singapore.

However, this approval is arguably even more meaningful - the United States is not only one of the world’s top meat markets but also home to many of the best-funded startups in this field.

So it is pretty clear that June 21st marks a significant milestone for the industry. And in a cool coincidence, it is also my birthday 🥳.

Still, over 85% of meat is produced outside the United States. To ensure the shift towards better protein happens on a planetary scale, other key markets must open doors to this new technology.

In my investing and my writing about alternative protein, I mainly focus on developments outside of the US. Naturally, I was curious how this decision might impact other countries and the availability of cultivated meat to consumers globally - from Asia Pacific to the European Union.

I reached out to several regulatory experts and industry insiders, typically more than one per key region. Some preferred to stay anonymous. Others agreed to be named (see footnotes for the list¹). However, given the sensitivity of this topic, specific comments should not be attributed to any particular person. Of course, even the top experts often have to do a fair amount of guesswork as they are unsure of exactly what local regulators are thinking and planning.

United States

Before we switch to a global view, let's recap what is known so far about the official approval in the US, including when and where consumers will be able to taste the products:

• Crucially, this is not a blanket approval for all meat made from cells. Rather, it is a green light for specific products from specific companies.

• Two US-based startups, UPSIDE Foods² and GOOD Meat (part of Eat Just, Inc.), obtained a so-called Grant of Inspection for their production facilities from the United States Department of Agriculture (USDA).
  

• That was the last step in the approval process. Both companies received a "No Questions Asked" letter from the US Food and Drug Administration (FDA), with UPSIDE Foods receiving their letter in November 2022 and GOOD Meat in March 2023. Just a few weeks ago, in June, both companies received approval for their labels from the USDA.

• One of my sources believes the USDA component of the approval happened much quicker thanks to the Biden administration's executive order on Advancing Biotechnology and Biomanufacturing; it supposedly gave Secretary of Agriculture Tom Vilsack a political cover to move faster.
  

• The USDA-approved term for the label is "cell-cultivated”, which may settle the long-standing naming debate (or maybe not - my source suspects some animal agriculture groups in the US are not happy; also, USDA keeps referring to the category as “cell-cultured meat” in their recently published documents)
  

• GOOD Meat and UPSIDE Foods will manufacture the approved cultivated chicken products at their respective facilities in the eastern region of the San Francisco Bay Area.

• The USDA published a directive on how facility inspections and label approvals will be conducted. They have also restricted imports of cultivated meat unless the country has a regulatory food safety inspection system that is equivalent to the United States.
  

• What will be the form factor and content of the products? According to UPSIDE, their market debut will feature "a whole-textured chicken product that is over 99% cultivated chicken cells". GOOD Meat is expected to use hybrid products similar to those currently sold in Singapore, which combine 50-70% chicken cells with plant-based protein (such as soy and/or mung bean) and plant-based fats.
  

• Where and when will it first be served? GOOD Meat will be served at chef José Andrés' Peruvian restaurant, China Chilcano, in Washington DC. UPSIDE Foods at Bar Crenn, led by three Michelin star chef Dominique Crenn, in San Francisco. At the time of writing, the launch dates have not been confirmed yet, but on June 27th, UPSIDE Foods published a photo of the first delivery with the caption: "The wait is almost over!"

Source: UPSIDE Foods

With recent USDA approvals for both startups happening nearly concurrently, each company might try to claim the title of the first to serve cultivated meat to customers in the US.

Who is more likely to win that race? At this point, hard to say:

UPSIDE Foods has a geographical advantage with the initial launch venue, Bar Crenn, located only about 11 miles from the production facility. On the other hand, GOOD Meat has more experience, having launched multiple versions of its cultivated meat at various venues in Singapore.

Updates from July 2nd and then August 3rd:

It turns out UPSIDE Food managed to be the first. The cultivated chicken dish was served by chef Dominique Crenn (quite literally - she brought the dishes to the diners) to five social media contest winners at Bar Crenn in San Francisco on July 1st. Each paid a nominal $1.

GOOD Meat product was served to invited guests a few days later, on July 5th, at China Chilcano in Washington, D.C.

As of August 3rd, both restaurants are accepting reservations from the public for a limited number of weekly/monthly tasting menus that include cultivated meat products.

Global perspective

Back to the main question: how will the full approval in the US impact regulatory processes and timelines in some key markets around the world?

There are several angles to consider here:

• Direct validation of the safety of this novel food - in short, it is reassuring when a major regulator conducts a full assessment and deems products safe for human consumption.

• Political and economic pressure not to be left behind - as this new industry is built, major global powers may want to lead or at least participate.

• Food security - for some countries, especially in Asia and the Middle East, this new technology can help them become more self-reliant in protein production and rely less on imports.

While there are common threads, the specifics differ by market:

(one more general note - similar to the US, most other jurisdictions operate on the assumption that individual companies will submit their applications for authorisation of specific products - no blanket approvals expected for the whole category anytime soon)

European Union

It's worth taking some time to understand the process and timelines for EU regulations, as how fast things move in this area may have major global implications, as discussed below when looking at other regions.

According to experts I talked to, there is a decent degree of clarity about the approval procedure of cultivated meat in the European Union, mostly thanks to the novel food regulations that came into effect on Jan 1st, 2018. Those specifically mention foods originating from cell culture (if genetic engineering is used, another regulation might apply).

The process consists of two main phases:

Phase 1 is a risk assessment by European Food Safety Authority (EFSA). Generally, it can be viewed as equivalent to combined FDA + USDA agencies reviews. The process is expected to take a minimum of 9 months from receiving a food safety dossier from a cultivated meat company.

But here is a catch: unlike in the US or Singapore, no pre-submission dialogue with the agency is allowed until the application is submitted. According to my source, EFSA will likely have many questions about filed dossiers, and each time they will “stop the clock” and add another three months to the review timeline, no matter how fast the company responds. The other expert mentioned an even longer six-month “penalty” when the application is not 100% complete or has some errors. A source claims this is the main reason why none of the cultivated startups in Europe has submitted their dossiers yet - they want to be very well prepared to avoid the process dragging on.

Will the US approval have any impact on this phase? One expert says EFSA (and EU in general) like “to do things their way”. But they also believe that since the US dossiers from GOOD Meat and UPSIDE Foods are public, the EFSA team will likely review them, and possibly it can influence what safety data is required for cultivated meat and seafood.

There is one more reason to be hopeful things will move faster, according to another expert: EFSA has recently held two “stakeholder meetings“ with a group of novel food companies - the kind of dialogue unheard of.

Phase 2 is the authorisation by European Commission that comes after EFSA approval. This can take anywhere from an additional 9 to even 36 months!

The group in charge of this authorisation is called Standing Committee on Plants, Animals, Food and Feed (or PAFF committee). The members of the committee are civil servants from all 27 EU member states - mostly representatives of respective ministries of health and/or agriculture.

To authorise any particular product, like cultivated meat, at least 55% of PAFF committee members representing at least 65% of the EU population must vote “yes”. When they do, the product can be sold to consumers in all 27 EU countries, as well as Iceland, Liechtenstein, Norway, and Switzerland.

Since this committee authorisation comes after EFSA’s safety assessment, that phase is largely political in nature. This fact gives experts some hope it can happen faster now that the US has approved the first cultivated meat product. One source said they are “hearing a lot of chatter” suggesting the EU “does not want the train to leave the station without them”.

Update from August 3rd:

Several new interesting developments in the weeks after I originally posted this article. In the Netherlands, authorities approved public tastings of cultivated meat and seafood. And the first application for approval of cultivated meat in Europe has been submitted by Israeli start Aleph Farms - not in the EU however, but in Switzerland.

United Kingdom

I talked to a source claiming familiarity with the UK's pre- and post-Brexit regulatory regime. They were not mincing words, describing the current situation there as a “total shitshow”.

According to them, not a single novel food approval was granted since Brexit, and the system is clogged with applications inherited from the EU, including “about 250 for CBD products alone”.

But they also see it as an opportunity in the mid to long term - as the system gets decoupled from the EU and there is even some healthy competition with continental Europe. Apparently, a local food safety agency recently ran a project with Deloitte, receiving 14 recommendations, out of which ten are in line with what the novel food producers are hoping for. That includes pre-submission consultation and other solutions more similar to Singapore than the EU.

Another expert believes the UK’s Food Standard Agency (FSA) is considering accelerating novel food approval processes for products that have received the green light in other regions, including the US.

However, in the first source’s opinion, things are unlikely to change much in the next 12-18 months until the next election.

Israel

In my alt protein global expert prediction survey earlier this year, more than half of responders pointed to Israel as the market that is most likely to be the next one after Singapore and the US to approve cultivated meat in 2023.

It is not hard to see why they would say this - the country is known as a food tech innovation hub. High-profile politicians, including the prime minister, have publically supported the industry and participated in tastings and photo ops. And by mid-2022, Israel-based cultivated protein startups raised ~36% of the sector’s global VC funding.

Local regulatory experts seem to be more cautious. The novel foods are regulated by the National Food Services (NFS) under the Ministry of Health (MOH). According to my source, the decisions might be influenced by approvals from regulators in the US, Canada, EU and Australia. Among those, MOH has a preference for European Union as they consider it “more strict”, as opposed to “easier procedure” in the US.

The source claims some applications have already been submitted in Israel by local cultivated meat startups. However, most of the major players also announced plans to launch internationally - Aleph Farms in Singapore and Believer Meat in the US.

This particular expert’s best guess is that the approval of cultivated meat in Israel will not happen before the EU’s.

Asia Pacific (APAC)

The main region of focus of my alt protein investing is APAC.

It is also where most of the world’s meat and seafood are made (over 40% and over 70%, respectively). While it has been the fastest-growing region regarding alt protein investments in 2022, I believe it is still underinvested compared to its share of the global market.

Overall, the experts in the region see the US approval as positive news that can “motivate” regulators in countries like Japan (MAFF and METI) and South Korea (MFDS and MAFRA). It seems to be common knowledge that local food agencies are looking at FDA and USDA for inspiration. Similar to other regions, there is also a hope that the political side of the process will be made easier by the US authorities “validating” the technology. I heard little specifics so far on how the timelines can be impacted in those two countries.

Let’s cover Singapore, Australia/NZ and China in more detail:

Singapore

Singapore Foods Agency (SFA) has famously become the first to approve cultivated meat for sale to consumers in late 2020 - a cultivated chicken product from GOOD Meat, the same California-based startup that now got a green light in the US.

Since then, SFA approved another two generations of products from GOOD Meat and the first co-manufacturing facility for cultivated meat from a local company Esco Aster. Since early 2021, GOOD Meat has been selling small quantities of cultivated chicken at selected partner restaurants in Singapore.

Not surprisingly, this resulted in a number of startups from other regions trying to secure the SFA’s approval and launch their products in Singapore: Dutch startups Mosa Meat and Meatable, Australian Vow and previously mentioned Aleph Farms from Israel.

My sources claim there are currently at least three applications already submitted to SFA - and more companies in earlier stages of talks. This amount of interest apparently overwhelmed the agency and led to some delays, with estimated timelines for approval extended from 9-12 months to 12-16 months. One source is suggesting another green light is due “any day now” (I was not able to cross-check this claim).

Is it viable that the recent US events will speed things up?

In Singapore, more so than anywhere else in the world, alternative protein and cultivated meat are an integral part of the national policy: it is called “30 by 30”, and aims to increase local food production from ~10% to 30% by 2030. Food security aside, Singapore can also benefit economically by becoming one of the hubs for this emerging industry.

So it is not hard to imagine that now that Singapore is no longer the only country where cultivated meat is available for sale, it will have an extra incentive to provide additional resources to SFA and other agencies involved in the build-up of this industry and continue to play a pioneering role.

In my previously mentioned survey, industry experts gave an 80% median probability of another company getting approved in Singapore in 2023. We will see if that is indeed going to happen in the next few months.

Australia & New Zealand

Food Standards Australia New Zealand (FSANZ) is arguably the most transparent from the global regulators. We not only know who and when submitted their application (Vow, January 2023), but also the timeline for the next steps (“The regulator expects to consult on [Vow’s] application in August and decide by March” via ABC News).

Because the process and the timeline are so public, the experts familiar with the market do not expect the US decision to have much direct impact. However, they think it may help build trust during the public consultation phase and possibly receive less political pushback when it comes to final decisions made at the Food Minister Meeting in 2024.

China

I saved the big one for last.

China is by far the largest meat and seafood market - bigger than the US and EU combined. And it continues to grow.

Cultivated meat cannot make a truly global impact without China opening its doors to it at some point.

There is no clear guideline yet from the local regulator, China National Center for Food Safety Risk Assessment (CFSA). But CFSA representatives met with USFDA peers in late 2022, after the first stage approval for UPSIDE Foods. The spokesperson for CFSA was quoted saying that “China will focus more on the food safety assessment of cell-cultivated meat in 2023” and is expecting to set up “expert working groups” this year.

There are also signs suggesting broader political support for the technology, such as its inclusion in an official five-year agricultural plan in December 2021.

However, the sources I talked to are clear: there is basically zero chance for China to approve a novel food that other major markets have not already endorsed. In fact, it would most likely require endorsement from not just one but several major markets.

In one expert’s multi-decade experience, only one drug product (and no food) was approved in China before getting the support of all or at least most of the key international regulators.

And which ones are considered “key” in this case? Historically China looked into the US, the EU and Japan. The source believes the European Union has the heaviest “weight” among those. Apparently, there were situations where the regulator specifically waited for official EU approval, even after positively completing its own safety assessment.

China considers the United States' approval to be less significant, largely due to the self-reported nature of the GRAS (Generally Recognized as Safe) designation by the USFDA. Technically, the FDA issues a "no questions" letter instead of a formal "stamp of approval" like the EU or Singapore.

According to the sources, it is unlikely that the current US + Singapore combination of cultivated meat authorisations will be enough for China to make a move. They believe EU approval might be necessary, or at minimum, another major jurisdiction like Japan.

Things may still move faster if China’s authorities decide to set a precedent and adopt a more progressive approach - which they might do, as long as they believe it can improve its food security and/or help them play a significant role in the global cultivated meat industry.

Hong Kong & Macau (HKSAR and MSAR)

I mentioned several times that cultivated meat can only be sold to consumers in Singapore and the United States.

But it might not be totally correct - it can be argued that some cultivated products could also be sold without additional authorisation in Hong Kong and Macau.

Both HK and Macau currently have food safety regulations that are different from those in mainland China. And according to some experts I talked to, no pre-market approval is required in either location. If a particular novel food product gets the green light from a major regulator (i.e. from the US, EU, Japan or mainland China), it is automatically recognised in HK and Macau.

This is how Impossible Foods has been able to launch in HK as the first international market as early as 2018. Its plant-based burger has a novel ingredient (soy leghemoglobin, or heme) - but USFDA has granted it GRAS status, and that was enough for HK debut. My sources close to Impossible Foods confirmed that the company did not apply for any extra approvals other than a food import licence.

So at least in theory, GOOD Meat or UPSIDE Foods should now be allowed to sell their products in Hong Kong and Macau.

There’s a small catch: local authorities still reserve the right to post-market inspections and can pull the product from the market if deemed unsafe for consumption.

Closing thoughts

I contacted two startups that have received initial approvals in the US for comments. Not surprisingly, both said they believe this will help spread the technology globally.

Rachel Pickel, UPSIDE’s director of international regulatory affairs, told me:

“We think that FDA and USDA approval is an important milestone that will give other countries confidence in the safety of cultivated meat and enable them to accelerate their respective approval processes.”

And Andrew Noyes, GOOD Meat’s VP of global communications & public affairs, shared this:

“The rigorous and thoughtful review by the FDA and USDA undoubtedly sends a signal to regulators and policymakers around the globe. We are hopeful that other countries follow suit because feeding our growing population in a way that is better for people and the planet is mission critical.”

Learning about the approaches of various novel food regulatory agencies in major markets has been fascinating. Although these agencies are independent, their decisions influence each other to varying degrees.

The European Union’s regulators seem to have an outsized influence. The approval of the first cultivated meat product by EFSA and the European Commission is likely to accelerate processes in Asia and other parts of the world.

I hope this happens soon, as there is no time to waste. We need all possible solutions to combat the climate crisis and improve the global food system.

Let me know what you think - in the comments below or on LinkedIn.

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🎟️ Events I recommend, attend or speak at

• SYNC: Climate Tech by Tech in Asia (Singapore, August 2023)

  • Apply for an invite here

• Good Food Conference by GFI (San Francisco, September 2023)

  • Register here (early bird rates till Jun 30th)

• AltProteins 2023 by Food Frontier (Melbourne, October 2023)

  • Register here (likely to sell out)

• Asia-Pacific Agri-Food Innovation Summit (Singapore, Oct/Nov 2023)

  • Asia’s flagship agri and food tech conference by Rethink Events

  • Part of Singapore International Agri-Food Week

  • Register here (early bird rates till Aug 17th)

1. Here are some of the folks that shared their perspective with me (thank you!):

• Hannah Lester, a food tech and alt protein regulatory consultant, CEO at ATOVA (and head of regulatory at Gourmey)

• Robert E. Jones, a president of the Cellular Agriculture Europe coalition (and head of public affairs at Mosa Meat)

• Mirit Zmiry, an international regulation manager at Sher Consulting

• Peter Yu, a program director at the APAC Society for Cellular Agriculture

• Wilfred Feng, an international food law expert and a senior counsel at Dentons Shanghai

• Megumi Avigail Yoshitomi, a director at the Japan Association for Cellular Agriculture (JACA)

• Sam Perkins, CEO of Cellular Agriculture Australia

2. Disclaimer: I have invested, directly or via Better Bite Ventures, in some of the companies mentioned in this article.