Sparked by the infant formula crisis, the FDA is about to undergo a major overhaul that will transform its human foods programme and regulatory affairs teams – what does this mean for alternative proteins?

In February 2022, the US Food and Drug Administration (FDA) recalled infant formula products made in an Abbott Nutrition facility in Michigan, after finding they may have been contaminated with Cronobacter sakazakii, which led to four infants being hospitalised, and two dying.

The FDA was roundly criticised for its oversight, not least because it first found out about the issue five months prior to the recall when a baby was hospitalised in September. In fact, in October, a former employee at the Abbott Nutrition facility had flagged concerns about food safety violations with senior FDA officials.

But it took a while for the government agency to take action. When it first heard about the infant being hospitalised in September, its officials were at the plant for an inspection, but didn’t find any serious problems or evidence of the bacterial contamination. In January, however, they returned to find at least five different strains of Cronobacter sakazakii in the facility.

It led to a long review process that will lead to the largest reorganisation of the FDA in history. This will mean an overhaul of the Office of Regulatory Affairs (ORA), which will be renamed and – alongside the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response – will be bridged under a newly created Human Foods Program.

It is the CFSAN’s Office of Food Additive Safety (OFAS) that is responsible for dealing with regulatory approval of alternative protein products – including cultivated meat and precision-fermented proteins – as well as handing out Generally Recognized as Safe (GRAS) notifications. So how does the reorganisation of the FDA affect alt-protein, if at all?

FDA hopes to ramp up pace and implement changes soon

The slowness and dysfunction of the FDA’s food functions is of little surprise to experts. An investigation by Politico revealed that food regulation is no longer a high priority for the agency, with drugs and medical products dominating both the budget and bandwidth. This has only been exacerbated since the pandemic.

“The food programme is on the back burner. To me, that’s problem no. 1,” Stephen Ostroff, a former FDA senior official who twice served as acting commissioner, told the publication. “There are a lot of things that languish. There’s nobody really pushing very hard to get them done in the same way that you’re pushing very hard to get the Covid vaccines out there and authorised. We don’t have that imperative and that pressure to actually make things happen on the food side of the Food and Drug Administration.”

This slow pace can also be seen in the FDA’s reorganisation itself, which was announced last January, and will still take quite a bit of time. “As a federal agency, the FDA must adhere to the required processes and notifications for reorganisations. Although the proposal has been finalised by the FDA, there are several critical steps remaining before implementation of the new structure can commence,” an FDA spokesperson told Green Queen.

“These include review by the Department of Health and Human Services and the Office of Management and Budget, providing the House and Senate Appropriations Committees with a 30-day notification period, issuing a Federal Register Notice and engaging in all necessary negotiations with Unions representing impacted staff.”

They added that the agency hopes it can begin implementing the proposed changes now, once it completes all the necessary review and approval steps. “The FDA remains committed to keeping the public up to date as the proposal continues to be developed,” said the spokesperson. (They did not respond to specific questions about the OFAS or the regulation and importance of alt-proteins.)

A focus on field-based operations

The reorganisation will see the ORA renamed as the Office of Inspections and Investigations (OII), with an emphasis on lab testing, field-based inspections, investigations, and import operations. It means about 1,500 ORA staff will be reassigned to product centres to work directly on inspections and investigations, with the goal of preventing the duplication of functions at the ORA.

At a recent webinar, outgoing FDA principal deputy commissioner Janet Woodcock said: “We’re really trying to transform different aspects of the FDA to make them more efficient, more effective, and so forth… Our mission seems to continually be broadening and we really do need to be able to meet our mission as much as our resources allow.”

This could potentially mean more frequent and more efficient inspections, which would lead to quicker resolutions and increased vigilance from companies too. In fact, businesses will need to adapt to the structure, as the FDA will likely be better equipped with investigators who are more specialised in specific product areas. In-house regulatory affairs and quality assurance staff should be well-versed with the new setup, while companies need to be aware of any updated compliance expectations and identify any new points of contact.

As for the CFSAN, its cosmetics regulation and colour certification functions will be transferred to the Office of the Chief Scientist, a move that is said to recognise the evolution and innovation in this product space, and better align the agency’s cosmetics subject matter experts with the Chief Scientist, who is “focused on research, science, and innovation that underpins the agency’s regulatory mission”.

What this means for alt-protein

The implications for alt-protein are less clear. The FDA has previously issued GRAS notifications for UPSIDE Foods and Eat JUST’s respective cultivated chicken products, as well as ‘no questions’ letters to precision fermentation companies Perfect Day, The EVERY Co, Remilk and Imagindairy.

Shannon Cosentino-Roush, president of the Association of Meat, Poultry and Seafood (AMPS) Innovation – a US alliance dedicated to cellular agriculture – expressed hope that the reorganisation won’t lead to “delays or a departure from FDA’s leadership” in advancing novel food technologies. “The industry remains committed to supporting the agency and this transition by advocating for [the] FDA to receive the resources it needs not only to achieve its mandate, but to ensure the US stays at the forefront of innovative advancements that are critical for American competitiveness, food security, and sustainability priorities,” she told Green Queen.

“Key among this is ensuring that the cell-cultured consultative process is robustly staffed to reduce delays in the review process that could impede progress, especially when the industry is rapidly advancing from R&D to commercialisation and is fuelled by start-up companies aiming to demonstrate commercial viability for this technology. We applaud [the] FDA for making efforts to strengthen its food program, and we share the agency’s goal of providing safe products to consumers,” Cosentino-Roush added.

A spokesperson for the Precision Fermentation Alliance (PFA), the US-based industry association, said that while it’s too early to comment, they expect the agency to continue to be a global regulatory leader for novel foods.

It’s a common sentiment that the FDA is stretched for resources, given its wide remit. “We are very strong supporters of further funding the FDA,” said the PFA representative. “We would hope a significant portion of these funds would be directed to the Office of Food Additive Safety, which handles GRAS reviews for the agency so that it can continue to build its scientific teams and carry on the high-quality reviews and timelines that have made the FDA the gold standard.”

Along similar lines, Laura Braden, associate director of regulatory affairs at alt-protein think tank the Good Food Institute (GFI), added: “GFI appreciates the cooperative approach FDA has taken in working with companies in the alternative protein industry to bring their products to market safely. As the agency reorganises its food regulation structure, adequate funding for FDA that allows it to stay at the forefront of scientific research and regulatory approaches is crucial for fostering an environment where safe innovation in the food sector can thrive.”

Cosentino-Roush acknowledged that the FDA’s approval of UPSIDE Foods and Eat JUST’s cultivated meat products “sent reverberations globally”, signalling that cultured proteins moved “beyond theory and into reality”. “As [the] FDA embarks on its reorganisation and shift in leadership, AMPS Innovation underscores the importance of maintaining the momentum and prioritisation of the cell-cultured consultative process, which serves as the backbone of the regulatory pathway to market for this key, innovative, and advancing industry,” she said.

“In 2024, we hope to see additional ‘no questions’ letters issued for other cell-cultured meat and fish products, bringing a range of new choices to market.”

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Amid a flurry of proposed bans on cultivated meat in the US and around the world, two senators have now introduced a bill that would prohibit the use of cultured meat in school meals.

Just as American schoolchildren are having to fight for even soy milk under the First Amendment, two US lawmakers are hoping to introduce a wider crackdown on alternative proteins in the education sector.

Senators Mike Rounds (Republican) and Jon Tester (Democrat) have proposed a bill to amend the Richard B Russell National School Lunch Act and the Child Nutrition Act of 1966 and ban the use of cultivated meat in US school meals.

Titled the School Lunch Integrity Act of 2024, the senators seek to prohibit cell-cultured meat from being served in schools under the National School Lunch Program (NSLP) and the School Breakfast Program (SBP).

“This common-sense bill will make sure our schools can serve real meat from our ranchers, not a fake substitute that’s grown in a lab,” said Tester, a third-generation farmer from Montana. “Montana ranchers grow the best meat in the world, that’s a fact – and our students ought to be getting the best in their school breakfasts and lunches every day.”

US senator promotes local beef over cultivated meat

Cultivated meat has already been approved for sale in the country, with the USDA granting clearance to Californian producers UPSIDE Foods and GOOD Meat last year. It made the US only the second nation to allow the consumption of these proteins – but Rounds’ office claimed that these actions “undermine the important work of American livestock producers”.

The USDA hasn’t yet issued any guidance over cultivated protein in the NSLP or SBP, but despite its approval of cell-based chicken from the aforementioned companies – which have also received a Generally Recognized as Safe (GRAS) certification from the FDA – Rounds questioned the safety of these products, citing a lack of research.

“It starts out with a piece of meat, a cell from an actual chicken and then it is developed artificially within the laboratory. We just want to make sure that’s not the stuff they are selling in our schools,” Rounds told local outlet Keloland.

In a statement, he said: “Our students should not be test subjects for cell-cultivated ‘meat’ experiments. South Dakota farmers and ranchers work hard to produce high-quality beef products. These products are often sold to South Dakota schools, where they provide necessary nutrition to our students.

“With high-quality, local beef readily available for our students, there’s no reason to be serving fake, lab-grown meat products in the cafeteria. I’m pleased to introduce this bipartisan legislation that benefits South Dakota producers and protects students from the unknown effects of cell-cultivated ‘meat’ products.”

Reflecting a wider disconnect between meat and climate change

It’s a rhetoric commonly used by sceptics of cultivated meat, which – as mentioned above – has been cleared as safe for human consumption by the US government. Promoting beef serves the interests of the country’s livestock industry – which receives 800 times more public funding than alternative protein companies – and encourages the consumption of a product that is proven to be the worst-emitting food.

Rounds will argue that he’s supporting local farmers and beef, which will have a lower carbon footprint than meat produced elsewhere. This is a commonly held misconception, because transport accounts for less than 1% of beef’s GHG emissions. “Eating local beef or lamb has many times the carbon footprint of most other foods. Whether they are grown locally or shipped from the other side of the world matters very little for total emissions,” explains Our World in Data’s Hannah Ritchie.

But perhaps Rounds can be forgiven for the confusion – he is, after all, a lawmaker in a country that fails to connect meat consumption with the climate crisis. One study found that 74% of Americans don’t think eating meat is bad for the environment, while another put that number at 41% for red meat. But peer-reviewed research has revealed that, when produced using renewable energy, cultivated meat can account for 92% fewer emissions, 94% less air pollution, and 90% less land use than conventional beef.

Even studies that critics routinely cite – such as a 2019 University of Oxford paper – are misinterpreted. While that research was undertaken when cultivated meat was much less developed and heavily reliant on fossil fuel power, it still found that the worst-case scenario for cultivated meat’s GHG emissions is better than the “best” conventional meat production systems for at least the next 100 years.

Livestock industry questions the safety of cultivated meat

Nevertheless, the bill was welcomed by animal agriculture groups like the US Cattlemen’s Association, R-CALF USA, National Cattlemen’s Beef Association and South Dakota Pork Producers, who seemingly ignored the implications of the safety rulings for cultivated chicken – a marker that other foods produced this way can also be regulated the same way in the future – by the USDA and FDA. In January, Israel became the first country to approve the sale of cultivated beef, after the Israeli Ministry of Health (IMOH) issued a ‘no questions’ letter for Aleph Farms.

“Science experiments belong in the classroom, not the cafeteria,” said Justin Tupper, president of the US Cattlemen’s Association. “The long-term health effects of consuming foods produced using cell-cultured technology [have] not been established. These products are too new and untested to be considered safe for our nation’s children.”

Bill Bullard, CEO of R-CALF USA, added: “The claim that cell-cultivated meat grown in a laboratory is as safe and healthful as real, natural meat has not yet been definitively determined. So, subjecting children to this nascent, scientific experiment is bad public policy. We applaud Senator Rounds’ bill that will ensure our children and grandchildren will not be encouraged to consume this controversial and unnatural product while at school.”

“We just want to make sure that our livestock producers in the upper midwest aren’t ham-stringed by schools suggesting that because of liberals in the area or individuals that don’t like ag that they are suddenly then being challenged to compete with cultured meat, which we think has a long way to go and hasn’t been properly tested at this stage of the game,” added Rounds.

Joining a global trend of cultivated meat bans

The legislation is reminiscent of the amendment of France’s climate law in 2021, which banned cultivated meat in canteens, similarly calling into question the safety of the products and the threat to livestock farmers.

That wasn’t the end of France’s anti-cultivated-meat push, which last year introduced a bill to prohibit the production and sale of these novel proteins throughout the country – not just in the education sector.

It’s part of a wider trend that’s developing around the world. A month before France’s proposal, Italy became the world’s first country to officially ban cultivated meat. And one of the farming groups that lobbied prominently for the law is now in talks with Hungary to push forward similar legislation in the country.

Austria has also voiced its opinion against cultivated meat, presenting a note to the EU’s Agriculture and Fisheries Council last week alongside Italy and France. It garnered support from the Czech Republic, Cyprus, Greece, Hungary, Luxembourg, Malta, Poland, Romania, Slovakia and Spain.

Meanwhile, senators in the US have been jumping on this bandwagon as well. Before Rounds and Tester introduced their legislation to the Senate, Republican lawmakers in several states had already floated the idea of prohibiting the general production and sale of cultivated meat within state borders.

It began with Florida, where House representative Tyler Sirois proposed HB 435, which seeks to ban the production, sale, holding and distribution of cultured meat within the state, imposing criminal penalties – including facing misdemeanours of the second degree, fines of $500 to $1,000, and license suspensions or stop-sale orders – on anyone violating these rules.

Shortly after, Texas governor Greg Abbott signed a bill requiring clear labelling of plant-based and cultivated meat, seafood and egg products, while Nebraska’s Real MEAT Act would mandate the word “imitation” on alt-protein if passed.

Then, in Arizona, House representative Quang Nguyen drafted HB 2244, a bill that would make it illegal to “intentionally misbrand or misrepresent” an alternative meat product as meat, while fellow Republican David Marshall went a step further with HB 2121, attempting to ban the sale or production of cultured meat.

And just this week, Wisconsin State Assembly representative Peter Schmidt – a Republican dairy farmer – proposed two bills against alternative protein, one of which put restrictions on the labelling of cultivated meat.

Rounds said it’s too early to tell how the bill will play out in the Senate. But really, the focus should be on finding ways to safeguard the environment, not promote food production methods that destroy it. Climate activists will hope these bills stop making the rounds.

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Ministers from 13 nations are pushing back strongly against the EU’s cultivated meat policy and asking the bloc to rethink its novel foods regulatory process in the interest of safety.

Some countries are resisting the move, but the EU could now revisit its legislation. Here’s what happened at the meeting, and what could come next.

Over the last few months, there has been increased parliamentary activity in governments around the world, specifically focusing on banning the production and sale of cultivated meat. While there are multiple reasons cited, the most common ones found across the board pertain to the safeguarding of national culture, livestock farmers, and consumers’ health.

This week, things boiled over. A delegation led by Austria, France and Italy – the latter two of which have already proposed a ban or gone through with it – presented a note to the EU’s Agriculture and Fisheries (Agrifish) Council meeting calling for a radical overhaul to cultured meat regulation in the region. This was supported by the Czech Republic, Cyprus, Greece, Hungary, Luxembourg, Malta, Poland, Romania, Slovakia and Spain.

Critics, however, have highlighted false claims made by the representatives of these nations, labelling the entire exercise as unnecessary. While the note only serves to set out a position and does not trigger any formal follow-up process, some believe that the EU might be considering revisiting its novel foods regulations anyway.

What did the note say, and how was it misleading?

The note states that cultivated meat raises many questions, including ethical, economic, social and legal concerns, as well as sustainability, public health, and transparency. It calls for a public consultation process and a “comprehensive impact assessment” to assess the development of these foods, as well as drawing guidelines based on the regulatory framework for new pharmaceutical products (including pre-clinical and clinical studies). It also touches upon labelling, urging the EU to prohibit these products from using meat-related terms.

“A transparent, science-based and comprehensive approach is necessary to assess the development of artificial cell-based meat production, which in our view does not constitute a sustainable alternative to primary farm-based production,” the ministers write in the note. They add: “We urge the Commission and all member states to take pre-emptive action against the monopolisation of food production and towards the diversification of primary farm-based food production guaranteed by European farmers.”

Alternative protein think tank the Good Food Institute (GFI) Europe has pointed out that there are many misleading claims made by the lawmakers. One of them is about cultivated meat’s environmental impact, referencing a non-peer-reviewed, UC Davis study funded by the meat industry, which is “based on incorrect assumptions” and deviates significantly from existing literature. Its findings have driven a major misinformation campaign on social media. Peer-reviewed research has shown that when produced using renewable energy, cultivated meat can account for 92% fewer emissions, 94% less air pollution, and 90% less land use than conventional beef.

The note referenced a 2019 University of Oxford paper too, when research on these novel proteins was “much less developed” and based on energy sources heavily reliant on fossil fuels. This contradicts the most recent data available, which underlines that even the worst-case scenario for cultivated meat greenhouse gas emissions is better than the “best” conventional meat production systems for at least the next 100 years.

The ministers argue that cultivated meat does not have higher animal welfare standards, referring to the use of fetal bovine serum (FBS). But FBS is being phased out by companies globally, and hundreds of animal-free media already exist. Some FBS-free formulations have been approved for sale, like Eat Just in Singapore and Aleph Farms in Israel.

Additionally, there were concerns about cultivated meat “being monopolised among a few large-scale industrial producers” and how that would affect small-scale farmers, but GFI Europe argues that these foods can be made by “companies of all shapes and sizes” (over 50 of the 160+ startups in this space are European), and can work alongside existing farming methods to diversify and strengthen our food supply.

The delegates further questioned the EU’s novel foods regulatory framework, but it is known to be the most robust in the world, which is why companies have found it challenging to file for clearance in the bloc. Other European countries – namely the UK and Switzerland – are already assessing dossiers. And as for the call to regulate cultivated meat as a pharmaceutical product, GFI Europe labels it “nonsensical”, pointing out that it’s “a food that will be made in food production facilities, so it’s essential that it is regulated as food”.

What happened at the council?

The note presented by Austria’s agriculture minister, Norbert Totschnig, made waves on the Agrifish Council floor. There was controversy even with the countries opposing cultivated meat, with Austria’s health ministry – which is responsible for food safety – noting that the move does not reflect the government’s position.

Other countries voiced their disagreement too. In the same week, the Netherlands took one step closer to becoming the first EU nation to allow public tasting events of cultivated meat, its representative stuck his neck out for the novel proteins in the EU Council as well. “We of course understand the concerns with regards to the public health and the future of livestock farmers, but also at the same time, we are talking about how do we secure the global food security, and the world population as we all know is growing fast, and so is the demand for animal proteins,” said Piet Adema, the Dutch food quality and agriculture minister.

“Therefore, we believe that it is important to support innovations that create production methods for animal proteins complementary to, and not as a substitute to, conventional sustainable production. So, more research is needed to ensure the safety and the lower energy use, and therefore, in the Netherlands, we invest in this research, and so I would plea to let’s also look at the opportunities of this development and not only see the threats.”

Similarly, Jacob Jensen, the agrifood minister for Denmark – a leader in protein diversification – said: “We understand the concerns that have been raised under this item, but Denmark remains very positive towards the development of new innovative biotechnological solutions that could lead to new sustainable proteins. And, like the Netherlands, we believe that we must also focus on the upside, and therefore, we look forward to the biotech initiative from the Commission that will look into the opportunities.

“We already have EU regulation on novel food in place. This sets a clear legal framework that is solidly based on science. Denmark sees no reason for hindering the development and marketing of cell-based products, as long as such products are safe and fulfil the legal requirements and as long as they are labelled in a way which is not misleading to consumers. If these requirements are met, it must then be up to consumers if they want to buy these products.”

Meanwhile, Stella Kyriakides, the EU’s health and food safety commissioner explained that the bloc’s existing regulatory framework for novel foods ensures that human health and consumer interests are well protected in a functioning internal market.

What happens next?

EU Commission vice-president Maroš Šefčovič had separately spoken about the need for a strategic dialogue on the future of agriculture, which was outlined by GFI Europe’s senior policy manager, Alex Holst. “As Commission vice president Šefčovič said, we need to ensure our food system is ‘fit for the future’, remains competitive and can respond to issues such as climate change, biodiversity loss and resource scarcity,” he said. “Cultivated meat can play a vital role in achieving these goals, and it’s a positive step that policymakers are becoming interested in developing a better understanding of this food.”

Holst noted how EU countries have already made strides in cellular agriculture, questioning the point of this debate altogether. “The EU’s Horizon Europe programme and countries like Germany, Spain and the Netherlands have already invested in cultivated meat R&D, recognising its potential to improve food security, reduce emissions, and satisfy [the] growing demand for meat,” he explained.

It’s curious that despite investing in cultivated meat, Spain was a part of the note’s supporters. There will be a focus on France and Romania too, as both have proposed bans on cultivated meat. But it’s unclear whether France’s bill will be debated or not, as it’s one of many such bills proposed by opposition parties. As for Romania, the proposal had been voted through by the Senate but is yet to be passed by the Chamber of Deputies.

But Romanians have mulled over the subject, with the Economic and Social Affairs Council of the Senate publishing an opinion on it. Its report on the proposed legislation stated: “The statement of reasons does not explain why synthetic meat should be banned. It is not clear why it could be dangerous to consume this product for the health of the consumers. Moreover, it is not clear why lab-grown meat is considered lower quality than ‘natural’ meat, considering the benefits of meat outlined in the statement of reasons. Therefore, the ban added through Article 5 is excessive, and it is necessary to eliminate it or provide further justifications.”

Meanwhile, Italy’s move to be the world’s first country to ban cultivated meat has been flagged as a violation of EU law, as the bloc is required to be notified to the EU Commission for comments by other member states. Plus, the country will not be able to prohibit the sale of cultivated meat produced outside Italy but within the EU, whose common single market enables the free movement of goods and services.

But changes may be afoot for Italy’s ban. “The Italian Government has committed to updating the law based on any feedback received from the European Commission, meaning there is a legal and political requirement to make changes to the cultivated meat ban if needed,” Francesca Gallelli, Italy policy consultant for GFI Europe, told Green Queen. “We also trust that Italy’s scientific community and civil society groups will play a vital role in holding the government responsible and making decisions based on evidence-based research rather than misinformation.”

Striking a similar tone, Julia Martin, cellular agriculture lead at ProVeg International, told Green Queen: “We hope it will be overturned. But we also hope that Italy will come round to seeing the huge benefits that Europe stands to gain from cultivated meat. The EU needs to support cultivated meat if it wants to bring down greenhouse gas emissions from the food system.”

Austria’s representative eventually tabled the note, which will not lead to any direct legislative changes. But ProVeg said the EU Commission “has the intention to revisit the guidance for novel food applicants”, with Martin further noting how the bloc recently funded FEASTS, the first Horizon Europe project on the impact of cultivated meat and seafood: “These actions should serve to reassure member states that these foods will be safe for consumers and will serve a significant role in addressing the environmental challenges with intensive animal agriculture.”

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