Talking heads: Uphill struggles

Nick Bradley somehow managed to squeeze eight panelists into a 60-minute webinar back in March 2024 to discuss 10 huge challenges for the alternative proteins sector. Here, he does his best to condense the content into this follow-up article with our fantastic Future of Protein Production Chicago speakers

Brimming with potential, new novel foods offer the opportunity to revolutionize our food system and address some of the most pressing global challenges. Whether environmental, such as reducing greenhouse gas emissions, deforestation, and water pollution, social such as fostering a more inclusive food system, helping to meet rising food demands, transforming health or even economic such as stimulating growth in related sectors such as agriculture and biotechnology, and more, the possibilities are exciting.

But the path is paved with hurdles that challenge even the most innovative of minds. There’s the cost conundrum, the flavor factor, the perception paradox, the regulatory maze, and the meat industry muscle to factor into the equation. And the challenges are seemingly mounting, not dissipating…

Talking points

In March 2024, eight Future of Protein Production Chicago speakers joined a Protein Production Technology International webinar as panelists to debate some of these challenges. With diverse backgrounds and specific areas of expertise, this made for a broad discussion of topics, including nomenclature, regulations, infrastructure, retail, IP, and more.

The eagle-eyed among our readers may have noticed that we had 10 challenges and only eight panelists. That’s because we placed two of our own into the melting pot.

For cultivated meat especially, the business case is currently in a state of flux, with immense potential, but significant hurdles remaining. Large-scale profitability is likely a few years down the line, contingent on overcoming production cost challenges and gaining wider consumer acceptance, so for the moment, cultivated meat appears to be focused on establishing a foothold in the premium market and building brand recognition. But will the investors have the patience to wait for profits?

As Clever Carnivore’s Kaitlin Grady explained, when it comes to business case, it needs to be carefully navigated to ensure its long-term success. By focusing on transparency, affordability, accessibility, and innovation, the industry can avoid the pitfalls and ensure cultivated meat becomes a force for good in the global food system with the ultimate potential to disrupt the entire meat industry.

Another hurdle revolves around controlling the narrative. And as we heard from Nicki Briggs, that’s not just about marketing; it’s about shaping the future of food. By engaging with consumers, policymakers, and the media, the industry can ensure its story is heard and pave the way for a more sustainable and ethical food system. Currently, though, the conversation around alternative proteins can be dominated by negative stereotypes such as ‘bland veggie burgers’ or the ‘ick’ factor associated with cell-cultivated meat. Ultimately, controlling the narrative empowers the industry to define itself and its place in the future of food – a golden opportunity to move beyond niche markets and become a mainstream force in shaping how we produce and consume protein.

Read on to hear more from Kaitlin and Nicki, as well as the thoughts of Arpad Csay from GEA Group, Kerry Rees from HGF, Eugene Wang from Sophie’s Bionutrients, Brian P. Sylvester from Perkins Coie, Panchali Chakraborty from Givaudan, and David Ziskind from Mach Global Advisors…

Arpad Csay, GEA

There’s somewhat of a bind for startups in the novel protein space, particularly cultivated meat, seafood, and precision fermentation. “Funding has dried up, creating a very difficult environment,” concedes Arpad Csay, Senior Director New Food NA at GEA Group. Furthermore, he points out, over the past few years especially, VC investors have grown impatient, feeling like many companies have overpromised and under delivered. “This has left many startups without their own infrastructure. Such a challenging funding environment also discourages investment in CapEx, making it hard for them to secure the standard equipment or facilities needed for pilot and demo production.”

For obvious reasons, this lack of infrastructure is an issue when it comes to commercialization. “Getting to commercial success requires several steps,” Csay continues. “The first crucial one is process development. Startups need access to third-party piloting facilities to validate their designs and processes for large-scale production, but this can be a big undertaking, taking anywhere from four months to a year.”

The next step is demo-scale production. And at that stage, Csay says startups need to make enough products with the right volume and functionality to excite potential customers, such as CPG or food ingredient companies, a critical factor for achieving commercial success.

What’s missing?

“The missing piece of the puzzle is the infrastructure for process development and demo production,” Csay says. “Without these facilities, startups lacking their own infrastructure face a very challenging path.”

Recognizing this critical gap, GEA recently invested US$20 million in a new Plant Technology Center in Janesville, Wisconsin, which will be home to an end-to-end process line. It includes GEA’s multifunctional fermenters or bioreactors together with high-shear mixing, sterilization, homogenization, cell separation and filtration equipment. “The center directly addresses the need for piloting and process development facilities,” Csay reveals. “We’ll be able to help startup companies in the fermentation and cultivated meat spaces develop and validate their production processes. Our team at the center brings decades of experience across the pharmaceutical, food, and beverage industries. This unique blend perfectly suits this industry, which truly merges these three sectors. With this expertise, we can ensure clean production [defining hygienic envelopes] and tackle challenges throughout the entire process, not just individual steps.”

Startups need access to third-party piloting facilities to validate their designs and processes for large-scale production, but this can be a significant undertaking

For startups in the sector wanting to advance to that next level, CDMOs, of course, are a viable alternative, although arguably a temporary fix. “Established players in pharma and biopharma are still the only option for many startups in the short term so they do address a crucial need,” Csay agrees. “Startups need to keep up the pace they promised investors. However, relying on CDMOs has drawbacks. First, it’s expensive, and their facilities are often booked far in advance. Second, their cost structures are designed for industries such as pharma, which have very different profit expectations than the food space. Despite these challenges, though, it might be the best option that they have until that much-needed dedicated infrastructure is finally built.”

The good news, according to Csay, is that things are changing, especially in fermentation. “Facilities such as ours and Liberation Labs’ demo production plant in Indiana are being built to address this gap,” he says. “By next year, I expect this new infrastructure to be up and running, significantly accelerating development for many startups.”

Panchali Chakraborty, Givaudan

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While the initial wave of plant-based products may have attracted consumers with their novelty, many fell short on taste and texture, leading to a drop in repeat purchases. And that prioritizing speed to market over quality may have hurt the plant-based segment overall, believes Panchali Chakraborty, Technical Director, Savory & Snacks at Givaudan. “This approach disappointed potential customers who were willing to give plant-based options a try,” she feels.

Chakraborty says it’s important to consider the context at the time though. “Back then, the industry was still young,” she continues. “There weren’t many experienced professionals who knew how to develop great plant-based products. While the scientists involved were brilliant, they came from diverse fields and had a lot to learn. They were essentially learning and improving as they went, with ‘Version 1.0, Version 2.0’ becoming a common way to describe product iterations.”

That may explain why some consumers – particularly those passionate about environmental and personal health – stuck with these early products despite their shortcomings. “They believed in the bigger cause,” Chakraborty says. “But for mainstream consumers looking to reduce their meat intake and incorporate plant-based options into their regular diets, the lackluster performance likely led to hesitation.”

As the plant-based sector matures and economies of scale kick in, attracting and retaining a broader customer base becomes even more critical. Producers simply can’t afford to alienate consumers anymore. That’s why Chakraborty reasons the future of plant-based alternatives lies in prioritizing quality alongside innovation. The big question, though, is, are consumers likely to give plant-based a second chance?

“There are some very positive developments happening across the food ecosystem, involving both industry and academia,” Chakraborty reports. “The pioneers raised awareness of plant-based foods, but there was a gap in knowledge about developing high-quality products with plant-based ingredients. The good news is that both industry and academic institutions are recognizing this. Several universities, such as UC Davis and Tufts, have established structured programs to address this gap. These programs are building the foundation for the next generation of scientists who will specialize in plant-based food development, driving innovation and growth. Ideally, these graduates will have a strong grasp of the fundamentals, consumer insights (learning from the shortcomings of first-gen products), and an understanding of the health benefits that are core to a plant-based diet.”

Healthy focus

The focus on health is a positive trend, Chakraborty says. “The initial marketing of plant-based foods centered around health and wellness, but concerns arose about ultra-processed products. While I disagree with judging foods solely on scary-sounding chemical names (water is a chemical!), there’s no denying that some early products were high in saturated fat and sodium. The industry now seems to be refocusing on health and getting back to basics. Leading players are also exploring incorporating plant-based ingredients into complete meal solutions, with a focus on global ethnic flavors where plant-based options naturally fit. Looking back, the industry may have rushed things a bit. We could have learned a lot from established plant-based cuisines around the world. But from what I’m seeing, things are improving. Version 2.0 products are better not just because of technological advancements, but also due to a shift in mindset about how these products can be consumed.”

The industry seems to be refocusing on health and getting back to basics

At Givaudan, Chakraborty says the mission goes beyond taste. “We believe in creating food experiences that are good for both you and the planet,” she says. “This philosophy drives our approach to plant-based proteins and other alternatives. We don’t just offer quick flavor or color fixes. Instead, we take a deep dive into understanding the proteins themselves. We have a robust R&D program where our scientists constantly analyze taste and texture gaps, allowing us to develop targeted solutions that truly make a difference.”

With its expertise and extensive portfolio, Givaudan feels well placed to tackle this challenge. “As someone with 10 years’ experience in this space, I can tell you that our approach mirrors Japan’s successful 20-year investment in plant-based product development. We believe in replicating these best practices to deliver impactful solutions. We’re also investing in creating a superior digital experience, developing tools to accelerate the entire product development process without sacrificing quality – quality over speed is our motto!”

Eugene Wang, Sophie's Bionutrients

For Eugene Wang, Co-Founder & CEO at Sophie’s BioNutrients, one of the big challenges for the plant-based protein sector lies in its incessant focus on ‘replicating’ the real meat experience. “Headlines scream about using plant-based ingredients or cell-based technology to achieve this, but let’s be honest, is it truly possible to perfectly mimic real meat with entirely natural, minimally processed ingredients? It’s bordering on mission impossible,” he feels.

Moreover, setting unrealistic expectations through such messaging often backfires. “Consumers are expecting a product that can’t quite be delivered, and that leads to disappointment,” he says. “And therein starts a vicious cycle. To meet those expectations, companies add more processing and ingredients, pushing the product toward the ‘ultra-processed’ category that consumers are wary of. And even with all that extra processing, the product may still fall short of the idealized ‘real meat’ experience.”

Carving out a new identity

The key to success, therefore, lies in finding a genuine identity for plant-based protein, and not simply mimicking meat. “This applies to cell-based technology as well,” says Wang. “While it may one day be possible to perfectly replicate all the components of meat (blood, muscle, bone), that technology is likely far off. Focusing on realistic solutions within the realms of possibility is crucial. Let’s set realistic expectations and focus on creating delicious, high-quality plant-based products for what they are, and not for what they’re not.”

In some ways, Wang feels the industry’s early focus on replicating the taste and texture of meat might have unintentionally neglected the vast potential for innovation in flavor profiles and utilizing these exciting new ingredients in ways that actually highlight their unique strengths. “Think about tofu,” he says. “It comes in over 10 different textures and flavors. Why can’t we achieve similar variety with pea protein, lentil flour, and all these exciting new ingredients? They don’t have to imitate meat – they just need to be delicious and have a satisfying mouthfeel. Leveraging technology in the right way is key. By focusing on creating unique flavor profiles and textures that stand on their own, we can avoid disappointing consumers who expect a ‘real meat experience’. Instead, we can create a whole new world of culinary possibilities. This shift in perspective is what the industry truly needs. When consumers aren’t comparing plant-based options to meat, but appreciating them for their own unique qualities, that’s when we’ll see a new level of success.”

Asked whether he believes, as some do, that alt proteins could one day entirely replace conventional meat, Wang remains pragmatic. “A complete shift to vegetarianism or veganism isn’t realistic for everyone,” he says. Instead, he feels the focus should be on making it more sustainable. “Similar to how the plant-based protein industry is innovating, there’s room for the conventional meat industry to explore sustainable practices. This could involve reducing its environmental footprint, for example, through practices such as improved feed production or manure management.”

Let’s set realistic expectations and focus on creating delicious, high-quality plant-based products for what they are, not what they’re not

Wang also believes that the environmental impact of some early plant-based options wasn’t entirely transparent. “The focus was often on rapid growth and brand promotion,” he says. “This sometimes led to the core mission of sustainability – which many pioneers initially championed – being neglected. Transparency wasn’t always prioritized. Limited technology for measuring environmental impact and a lack of established standards might have contributed to this. The complexity of plant-based supply chains, with ingredients sourced from various locations, were also problematic when it came to tracking environmental footprints. But the landscape is changing. Consumers are demanding more transparency, and the industry is responding.

“Consumer groups are scrutinizing company claims more than ever before, leading to a rise in industry-specific certifications,” Wang reports. “I am seeing more and more industry alliances trying to get certain certifications done and promoting their industry. This increased focus on independent verification will likely continue, ultimately benefiting consumers and creating a more trustworthy marketplace.”

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Nicki Briggs, Here/There

Accurate and well-considered nomenclature is a key factor in the success of alternative proteins, fostering consumer trust, avoiding confusion, and helping to establish a thriving market for these innovative products. “We’re seeing a lot of different approaches to positioning these novel foods in the market,” says Nicki Briggs, Founder & Principal, Here/There. “There’s no single perfect strategy – some companies highlight the technology heavily, while others completely omit it,” she says. “But for trust to build, transparency and clear communication are crucial. Consumers care about delicious food, so that’s the starting point. We need to help them understand the product through familiar aspects such as taste, and address pain points such as flavor preferences and dietary needs. Perfect Day’s use of ‘animal-free whey protein’ instead of ‘fermented whey’ is a great example of leading with familiar references.”

The bigger question for our industry, though, is how can we help retailers navigate these new categories? “The answer lies in a two-pronged approach,” Briggs suggests. “First, let’s emphasize familiar aspects like taste and how the products fit within existing categories. Second, let’s be transparent about the values these products embody, like sustainability and ethical sourcing. But remember, responsible communication is key – no unsubstantiated claims. By focusing on these areas, we can equip retailers to effectively sell these novel foods and connect with consumers.”

Retail efforts

The good news, though, is that retailers are curious about this space, even if some are not yet ready to stock the products. “They want to understand these novel foods and how best to introduce them to their shoppers,” Briggs reasons. “To build strong relationships, we need to share data and industry trends with them. Formal studies or smaller-scale surveys can show how our products meet consumer needs and taste preferences compared to conventional options. But remember, retailers need reassurance that their customers will embrace these new products, especially considering some past challenges with plant-based options.”

Briggs also says retailers need help with product placement, and that’s not just a case of branding but about fitting into existing categories. “They have limited shelf space, so they need to know how to merchandise our products alongside familiar items and use appropriate terminology,” she feels. “Equally vital is educating them on what these products aren’t. Precision fermentation isn’t plant-based, for example, so clear communication is key. Finally, to make ourselves appealing partners, we need to demonstrate how we can drive traffic to stores through PR and attract new customers. We can also leverage existing resources such as supermarket dietitians to educate shoppers. In-store demos and educational initiatives are crucial – we can’t expect retailers to shoulder the entire burden of consumer education.”

Finding a balance between clear labeling that protects consumers and allows the alt protein industry to develop its own identity is also a key challenge. So, on that note, what is Briggs’ take on the labeling debate? “I think it’s evolving, and it will continue to evolve,” she responds. “First, we need better collaboration within the industry itself. Trade associations should bring together cultivated meat, precision fermentation, and biomass companies. It’s crucial to agree on a common industry name. Right now, the abundance of terms such as ‘precision fermentation’, ‘cultured meat’, ‘molecular farming’, and ‘biomass’ creates confusion, even within the industry. So, just imagine how lost consumers must feel!”

Retailers need reassurance that their customers will embrace these new products, especially considering some past challenges with plant-based options

Briggs says we also need to build connections with stakeholders outside the industry, particularly existing commodity groups. “Reaching a consensus on terminology with their support would be beneficial,” she says. “Regulators are much more likely to listen to a unified voice from a trade association backed by these groups.”

Beyond terminology, the former VP of Corporate Communications at Perfect Day advises we need to collaborate on messaging and best practices. “Examples include non-transparent language about the technology, unsubstantiated claims, and rushing to market before regulations are in place.” Finally, she says, collaboration is essential for establishing industry-wide standards on allergen labeling and safety. “These steps will build trust and establish our reputation for responsibility, which is critical for success. After all, a big part of what we’re doing now is building trust with consumers.”

Kaitlin Grady, Clever Carnivore

As few would have failed to have noticed, the exciting field of cultivated meat is currently facing a few hurdles in the USA, with US states Florida and Arizona outlawing the production and sale of cultivated meat or seafood, and numerous others restricting the labeling of cultivated meat products.

According to Kaitlin Grady, Director of Strategic Partnerships & Public Affairs at Clever Carnivore, the ranching industry has been “lobbying aggressively” against cultivated meat as they “perceive it as a threat”. That opposition has aligned with some conservative talking points that emphasize “getting science out of foods” and supporting “real farming”, which makes it all the more crucial for cultivated meat proponents to strengthen their message for Republican legislators.

Cultivated meat advocates are therefore focusing on talking points that resonate with Republican values. They argue cultivated meat simply aims to “meet the demand” for meat, which is projected to “nearly double by 2050”, as Grady highlights. Bans on cultivated meat, they suggest, “hinder research, innovation and economic growth”. A ban in Florida, for instance, would impact the University of Florida’s ongoing research in this field.

Cultivated meat companies also often rely on established industries for essential materials. For instance, many companies incorporate sugarcane into their cell culture media. Grady believes that a ban in Florida, a major sugarcane producer, would disrupt these vital partnerships and potentially harm the state’s economy. Most importantly, proponents argue, banning cultivated meat is “anti-free market” and government overreach. It “limits consumer choice”, Grady says, and “denies consumers access to potentially desired food options”.

As we know, the USA and Israel are leaders in cultivated meat research and share a “critical biotechnology partnership” that includes this technology. Bans could therefore send a “strong signal against Israel” and weaken this important collaboration, Grady believes.

Politics aside, though, why do we even need cultivated meat? “It’s a critical question,” Grady says. “By 2050, we’ll need to feed 10 billion people, requiring at least double the current meat production. However, continuing our present methods is unsustainable due to land and resource limitations. Cattle are the worst agricultural greenhouse gas culprit. Our current production is highly inefficient – for example, it takes nine calories of grain to produce one calorie of chicken (the most efficient meat animal), while beef requires a staggering 20 calories to one. Consumers recognize the downsides of conventional meat production, yet per-capita consumption hit a record high in 2022 and is expected to rise further.”  

Moving to our Chicago facility with significantly larger bioreactors allows us to scale up production dramatically

In the face of such stats, simply asking people to eat less meat isn’t the answer. “The solution lies in creating more efficient meat alternatives,” continues Grady. “We can biomimic meat with plants, develop meat via fermentation, or cultivate meat directly from cells. According to research by SPINS and GFI, consumer priorities for alternative meat are clear: taste, price, and convenience. Therefore, our focus should be on creating products that taste as good or better, and cost the same or less as conventional meat. We also recognize that some consumers – even when plant-based options reach price and taste parity – will still prefer meat from animals. This is where cultivated meat comes in.”

Market focus

The market for cultivated meat is projected to reach a significant size in the coming decades, with estimates ranging from US$30 billion to over US$500 billion by 2050. But the industry is still in its early stages. Companies still need to refine production processes and achieve greater economies of scale to reach price parity with conventional meat.

And with the leading lights such as Upside Foods and Good Meat – the first two to obtain approvals in the USA – recently adjusting their scaling timelines and strategy, could it be that the business case for cultivated meat is even more challenging than the technical and regulatory hurdles? “At Clever Carnivore, we are leading the charge in affordable cultivated meat,” Grady responds. “Moving to our Chicago facility with significantly larger bioreactors allows us to scale up production dramatically. Our approach – using low-cost, highly optimized cell culture media, robust, non-GM methods for cell-line development, and innovations in bioreactor design – position us to scale accessible, affordable, delicious consumer meat products.”

Kerry Rees, HGF

The biggest challenge of bringing cultivated meat to market lies in the immense scale required, believes Kerry Rees, Partner & Patent Attorney at HGF. “We have a successful F&B group comprising patent attorney, trademark attorneys and IP solicitors who work with a wide variety of food-tech companies on their IP strategy,” says Rees, whose own background is in biochemistry. “I have been in the IP profession for more than 20 years, working primarily with SMEs on all aspects of their IP strategy, and also with investors on IP due diligence matters. For about the past 10 years, I have worked increasingly with alternative protein companies, ranging from those in the cell agriculture space to precision fermentation and plant-based proteins.

“Traditional cell culture, designed for therapies, operates on a small scale (less than a cubic meter) with low cell density,” adds Rees, highlighting the challenge of scaling cultivated meat specifically. “To meet food production demands, we need to shift to large-scale production (tons) with high cell density. That transition from grams to tons is a huge hurdle. Scaling up cell growth density, designing bioreactors for efficient nutrient delivery at high cell concentrations, and optimizing media for large-scale production are all crucial steps we need to overcome. Bridging the gap between scientific feasibility and large-scale food production is a major obstacle, but with continued innovation in bioreactor design, media optimization, and advanced manufacturing techniques, I really believe that we can bring cultivated meat to the mainstream market in meaningful and impactful way.”

The IP factor

From an intellectual property (IP) standpoint, Rees says the relationship between scaling cultivated meat production and IP is complex and intertwined. He also says it’s important to understand that groundbreaking inventions aren’t the only path to patenting. Cultured meat products, and the technology required to make them, have great potential for protectable IP – patents for culture media, cell lines, bioreactors, culture methods and downstream processing of the cells to form the meat product, for instance.

“Even incremental innovations can be patentable if they’re new, non-obvious, and address scaling challenges,” Rees suggests. “Think improvements in bioreactor design, even if the benefits seem small. Similarly, new culture conditions such as temperature or media composition – or even using gene editing techniques to speed up cell division while maintaining their integrity – could all be patentable.”

Having your own IP strengthens your position for cross-licensing deals with other companies in the field

The key, Rees stresses, lies in a strategic approach to IP. “Existing patents might not restrict things such as bioreactor size or specific reaction conditions. So, careful analysis is crucial to avoid infringing on others’ patents. Having your own IP strengthens your position for cross-licensing deals with other companies in the field.”

Cell line stability is also critical, he notes. “Techniques for ensuring stable and potentially immortal cell lines are essential for consistent production and safety,” he continues. “By focusing on these areas – incremental innovation, strategic IP protection, and cell line stability – the cultivated meat industry can overcome scaling hurdles and bring this exciting technology to the market.”

Some developments won’t be patentable however. They might be obvious developments, for example, in which case alternative protection by way of trade secrets might be more appropriate. “In any case, for a valuable company asset to qualify for trade secret protection requires active management of a company’s trade secret register and protective procedures should be put in place,” advises Rees. “There may be important branding associated with the company and the product which adds value to the company and may be protectable with trademarks. There might be registered design rights associated with the look of the product, its packaging or apparatus that are used in its manufacture. It may be possible to protect the cultured meat product itself, together with cultured fats and other ingredients, for example, but thought will need to be given by companies whose commercial product is the cultured meat and the regulatory approval for the product on the one hand, and patent protection on the other. Regulatory approval for ‘novel’ foods might face more hurdles whereas novelty is fundamental requirement for patent protection.”

David Ziskind, Mach Global Advisors

According to David Ziskind, Managing Partner at Mach Global Advisors, the real challenge in cultivated meat lies in building the infrastructure and manufacturing capacity to truly make a difference. Pilot programs and lab prototypes are valuable proofs of concept, but to feed a growing global population, large-scale production is a must. “The key issue, then, is scaling up our capability to manufacture these new food sources,” he says.

If you’re going to succeed, though, Ziskind says you need a plan, and that plan needs a lot of detail. “It’s not just about the exciting parts; it’s the nitty-gritty aspects such as utilities, location, logistics, labor, transportation – everything that goes into building a facility. You need to understand what your capital costs will be upfront to build this facility, as well as the ongoing operational costs to keep it running. And certainly, with today’s focus on sustainability, companies are increasingly aware of the environmental impact – both during construction and in ongoing operations.”

The biggest mistake Ziskind sees is skipping upfront planning. “In this fast-paced industry, especially for startups, the urge is to ‘move fast and break things’,” he says. “However, taking the time to develop a well-defined plan is crucial. This plan should outline costs, potential cost increases, and anticipated challenges. Another hurdle arises with new technologies. Here, companies might design a factory while still scaling up the production process. This creates a balancing act: figuring out what’s needed to move forward without waiting for every detail, but also avoiding costly mistakes due to a lack of planning.”

The risk business

Ziskind also cites risk management as critical – there’s always something that could go wrong. “That’s why it’s vital to have a risk management plan in place,” he suggests. “This plan should identify all the potential risks that a company might face.”

In the cultivated meat sector, especially, there are some specific risks to consider. There are bound to be uncertainties involved with new technologies used in cultivated meat production. Scaling up a process from a small lab setting to a large-scale production facility can be challenging and lead to unforeseen issues. Financially speaking, this industry is still young, and there’s a chance that financial projections might not be met. And let’s not forget that building and operating a cultivated meat facility requires specific infrastructure, and there could be challenges related to its availability or functionality.

Taking the time to develop a well-defined plan is crucial. This plan should outline costs, potential cost increases, and anticipated challenges

“The key thing is to identify these risks, figure out a plan to address them, and then balance the risk with the cost and flexibility of your approach,” Ziskind says. “Not every risk needs to be completely eliminated. Some can be managed or tolerated, but it’s important to understand the potential cost and time impact of each decision.”

When asked what advice he would have for startups in the sector, Ziskind says his core belief – backed by experience – lies in the immense value of upfront planning. “The groundwork you lay in a project’s early stages has a far greater influence on the final outcome than scrambling later on,” he says. “Plan early, iterate as needed, and develop a well-defined plan – these are the hallmarks of a project with a higher chance of success.”

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Brian P Sylvester, Perkins Cole

The mid-2023 triumphs of GOOD Meat and UPSIDE Foods receiving their green lights from the USDA seem a lifetime ago, given the travails the cultivated meat sector has faced since, most notably the pushback from a number of US states.

The support for a nationwide ban on cultivated meat seems limited, albeit it’s remains a hot-button issue in some areas. Public opinion likely varies regionally, and more data is needed to understand the national landscape. Of course, the cultivated meat industry is actively opposing bans, and federal oversight may be the best path forward to ensure safety, clear labeling, and responsible development of this new technology.

At the time of press, Florida and Alabama have banned the sale, production, and distribution of cultivated meat, while other states – including Tennessee and Arizona – have considered similar bans although they haven’t passed them. Iowa even has a restriction on schools buying cultivated meat.

“Any new technology faces scrutiny, and cultivated meat is no exception,” says Brian P. Sylvester, Partner at Perkins Coie, who is one of the world’s leading regulatory experts in food tech.

“That’s why scrutiny and legislative activity to ban these products at the state level isn’t surprising,” he continues. “Since cultivated meat became part of the public discourse at the FDA, USDA, Capitol Hill and beyond several years ago, there have been continued attempts at both the federal and state levels to limit the reach of this product either by way of restrictive labeling rules and more recently outright bans.

“The Florida bill specifically has potential fines of up to US$500 and 60 days in prison. It’s unclear how this Florida bill may influence legislative activity on other states, but it’s not inconceivable that a number of other states may at least attempt to pass similar laws.”

Clearly there are political motivations afoot, and other states such as Alabama, Arizona, Kentucky, and Tennessee are considering similar bans, but it’s concern enough for The Good Food Institute to be actively monitoring the developments, to the extent that it is tracking proposed bills in a spreadsheet.

Media relations

Whatever the motivations, though, the media coverage has not been helpful, nor does it send out the right signals to would-be investors.

But regulatory hurdles could also be playing a role – and not just in terms of approvals. “When you submit your safety dossier to the FDA for cultivated meat, it’s very important the manufacturing information and all safety information match the process you plan to commercialize,” Sylvester says. “In other words, if you optimize the process later – which is expected – then it is prudent to consider whether the change merits an update to your submission, and this is the type of conversation you’d have with your regulatory counsel or advisor and ultimately, in certain cases, with the FDA itself.”

More certainty around the cultivated meat approval process would definitely boost innovation

A conundrum for the US cultivated meat industry right now is the lack of clear rules. The FDA hasn’t published its final guidance yet, which Sylvester says would be a huge help. A lack of clear timelines could have several negative impacts. Without a clear understanding of how long the approval process takes, companies might be hesitant to invest in R&D for cultivated meat products, which could stifle innovation in the field. Uncertain timelines can also lead to inefficiencies for companies, which might be spending resources preparing applications that don’t meet the (yet unknown) requirements. Investors may also be less willing to fund startups due to the uncertain regulatory landscape and timelines. Potentially, we are already seeing this play out, given the closure of SCiFi Foods (announced in June 2024).

“At present, there’s currently no set timeline for how long the FDA will take to review a cultivated meat submission through the Cell Culture Consultation premarket review process,” Sylvester explains. “When FDA publishes guidance in the future, we anticipate it will provide more clarity regarding the mechanics of the process and information needed to facilitate a streamlined review. More certainty around the cultivated meat review process would definitely boost innovation.”

If you’re a statup, that makes it even more vital that when it comes to regulatory strategy you engage with the right advisors early enough so you can ensure your submissions are meeting the expectations of the regulators. And that’s where Brian Sylvester and his food regulatory team come in.

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