5 Challenges in Global Cultivated Meat Regulation

David Bell
14 minutes ago
11 min read

The cultivated meat industry is advancing but faces five major regulatory challenges that hinder its global growth:

Safety Standards: Approval processes differ across regions, forcing companies to duplicate efforts and increase costs.
Labelling Issues: Disagreements on terminology like "cultivated" or "lab-grown" complicate international marketing.
Trade Barriers: Import tariffs, inconsistent classifications, and local bans delay market access.
Intellectual Property Conflicts: Balancing transparency with protecting proprietary data is costly and slows progress.
Regulatory Gaps: Many countries lack the infrastructure and expertise to assess cultivated meat, creating uneven market readiness.

A unified regulatory framework is needed to streamline approvals, reduce costs, and ensure fair trade. Without global collaboration, these issues will continue to stall the industry's potential to provide a scalable alternative to conventional meat.

1. Different Safety Assessment Standards

The way countries regulate cultivated meat varies significantly, creating challenges for global producers. In the UK and EU, cultivated meat falls under the "novel food" category. This means companies must submit a comprehensive dossier to either the European Food Safety Authority (EFSA) or the UK's Food Standards Agency (FSA). These dossiers need to detail everything from the product's composition and production methods to toxicology and nutritional data [9].

The United States takes a different approach, involving two agencies. The FDA assesses the safety of cell lines, culture media, and manufacturing processes, while the USDA oversees inspection and labelling for meat and poultry products [9]. Meanwhile, Singapore's Food Agency (SFA) evaluates cultivated meat on a case-by-case basis, focusing on aspects like cell line origins, media components, hazard controls, and the manufacturing environment within its own novel food framework [9]. These differences highlight the need for global regulatory alignment to support industry growth.

For companies, this lack of harmonisation is a logistical headache. Even if a product passes US regulatory checks, separate dossiers must still be prepared for the UK and EU, often requiring additional studies. As of mid-2025, only a small number of products - such as cultivated chicken in Singapore, the US, and Australia, or cultivated beef in Israel - have successfully navigated these varied approval systems [9].

These divergent standards force companies to duplicate efforts, from conducting new studies to maintaining separate regulatory teams and tailoring submissions for each region. This process can add months or even years to approval timelines, while also inflating costs. Legal and scientific consulting fees pile up, and the capital required for early production increases, driving up the price per kilogram. For UK-based firms, the absence of harmonised international standards - such as those promoted by Codex Alimentarius - further complicates efforts to scale across borders [8].

To address these inefficiencies, some companies are adopting what’s known as a "global by design" regulatory strategy. This approach focuses on meeting the strictest standards from the outset, ensuring safety programmes can be applied across multiple regions. Early collaboration with key regulators - like the FSA, EFSA, and FDA - helps companies agree on study designs that generate reusable data for toxicology, allergenicity, and process validation [9]. Organisations like The Cultivarian Society are also stepping in to support this effort, offering shared resources, such as model dossiers and best-practice examples, to reduce duplication and speed up global regulatory alignment.

2. Inconsistent Labelling Requirements

The question of what to call cultivated meat is far from settled. Terms like "cultivated", "cell-based", "cell-cultured", "lab-grown", "slaughter-free", and "cultured" are all in circulation, with different countries adopting or rejecting various options [6].

This lack of agreement creates hurdles for producers aiming to sell internationally. A label that’s perfectly acceptable in one country might be rejected - or even deemed illegal - in another. This forces companies to adjust their packaging and marketing strategies for each market, adding another layer of complexity and cost [8]. The issue plays out differently depending on the region.

In the United States, for instance, the USDA's Food Safety and Inspection Service (FSIS) requires pre-approval for labels on cultivated meat and poultry. These labels must also include the USDA inspection mark [7]. However, at the state level, some states have passed or proposed laws that restrict the use of terms like "meat" or "beef" to products derived from slaughtered animals. This creates a direct conflict with federal policy, adding another layer of compliance challenges [10].

In Singapore, the Food Agency takes a different approach, carefully reviewing product names to ensure consumers understand that the product is derived from animal cells [7].

Meanwhile, in Europe and the UK, cultivated meat is regulated under the Novel Food framework, which prohibits any labelling that could mislead consumers. Discussions are ongoing about whether terms like "burger" or "steak" should be allowed on cultivated products and what qualifiers might be required [6]. In the UK, while the Food Standards Agency is currently assessing the safety of these products, detailed labelling rules have yet to be finalised. This leaves open the possibility that the UK could diverge from the EU’s more cautious stance [2].

The push for clear and neutral terms like "cultivated meat" is not just about consumer clarity - it also compels producers to create market-specific labels, which drives up legal and design costs [6][7].

To address these inconsistencies, policy bodies like the US Congressional Research Service have called for the establishment of Codex Alimentarius labelling standards to promote global uniformity [8]. Until such standards are in place, companies face the costly reality of redesigning labels for every jurisdiction they enter. These disparities not only increase expenses but also delay market access, underscoring the broader regulatory challenges facing the cultivated meat industry.

3. International Trade Barriers and Tariffs

Even when cultivated meat secures approval in one country, selling it internationally presents a whole new set of hurdles. As of mid-2025, cultivated meat has been approved for sale in Singapore, the United States, Australia, and Israel. Meanwhile, regulatory frameworks are still being developed in regions like the EU, UK, New Zealand, South Korea, and Switzerland [9]. This fragmented landscape means that approval in one country, like Singapore, doesn't automatically grant access to markets such as the EU. Companies must navigate separate regulatory requirements for each jurisdiction, including preparing unique dossiers, conducting safety assessments, and meeting labelling standards [9]. This creates a maze of trade barriers that complicates global expansion.

On top of varying approval timelines, cultivated meat encounters trade challenges that conventional meat does not. These include import tariffs, sanitary and phytosanitary (SPS) measures, and technical barriers to trade (TBT), such as differing safety and production standards [9]. Because cultivated meat is often classified as a novel food or biotechnology product, it is subject to stricter pre-market authorisations, facility inspections, and additional documentation requirements at borders. In some cases, even after national regulators approve the product, state-level bans or moratoria can act as unofficial barriers, blocking distribution [2].

These obstacles hit early-stage producers particularly hard. Cultivated meat production is already expensive, largely due to the high costs of culture media and growth factors [12]. Adding import tariffs and compliance expenses only pushes retail prices higher, making it harder for cultivated meat to compete with conventional options and slowing its adoption [2].

The World Trade Organization (WTO) framework does provide some potential remedies. Under WTO rules, cultivated meat would likely fall under the General Agreement on Tariffs and Trade (GATT), the SPS Agreement, and the TBT Agreement. These agreements require that trade measures be non-discriminatory, science-based, and not overly restrictive [9]. However, uncertainties remain about how cultivated meat should be classified - whether as meat, a novel food, or something entirely distinct - and whether it should be treated differently from conventional meat [9]. If a country allows domestic cultivated meat but imposes excessive restrictions on imports, such actions could be seen as protectionist and may lead to trade disputes [9].

To ease these challenges, policymakers could explore mutual recognition agreements or equivalence determinations, enabling countries to accept each other's safety assessments and inspection processes. This would reduce the need for redundant reviews [9]. International organisations like the FAO/WHO and Codex Alimentarius could also play a role by establishing unified, science-driven guidelines for areas such as cell sourcing, culture media, and production hygiene. Additionally, creating clear and harmonised customs codes and legal definitions for cultivated meat would help streamline border procedures and reduce delays. Until global alignment is achieved, companies will continue to face fragmented supply chains and higher compliance costs.

4. Intellectual Property and Data Protection Conflicts

Intellectual property is a cornerstone of the cultivated meat industry. Companies pour significant resources into developing proprietary cell lines, growth media, scaffold materials, and bioreactor designs, relying on patents and trade secrets to recoup their research investments. However, a major tension exists: regulatory transparency demands clash with the need for confidentiality to safeguard competitive advantages. Both regulators and consumers are calling for detailed safety data, but companies must keep critical process information under wraps. This conflict becomes even more pronounced when navigating international borders, where inconsistent data protection rules complicate approval processes.

The disparity in global standards for confidential business information adds to the complexity. For instance, under EU and UK Novel Food Regulation, applicants benefit from five years of data protection, during which regulators cannot reuse proprietary safety data without permission. While this offers protection, it also creates temporary monopolies, potentially delaying the market entry of competing products by several years. In contrast, the U.S. employs a more flexible approach through the FDA and USDA, requiring repeated trials for multinational approvals. This lack of alignment can increase approval costs by as much as 30% for companies operating across multiple markets [3][6].

Patent disputes further complicate matters. Overlapping claims on technologies like serum-free media and scaffolds risk creating a "patent thicket" - a tangled web of conflicting patents that raises costs and discourages new players from entering the field. A prominent example is Aleph Farms' 2023 submission in Switzerland, where approval was delayed due to disputes over proprietary cell-culturing data with U.S. partners. This case highlighted the friction between Israel's intellectual property-friendly policies and Switzerland's stricter data exclusivity rules [9][6]. Such conflicts have contributed to a 25% decline in cross-border investments since 2023, with 75% of companies identifying data protection as a key obstacle to scaling [4].

The challenge extends to cross-border collaboration, where differing data-sharing regulations create additional hurdles. While GDPR in the EU mandates explicit consent for data sharing, U.S. frameworks are more lenient, leaving companies to navigate a maze of rules about what can be disclosed and what must remain protected in each jurisdiction.

Some experts suggest adopting global patent pools, similar to those used during the COVID-19 vaccine rollout. These pools would allow shared access to non-core intellectual property, such as safety data, while safeguarding innovative processes. This model could streamline approvals in the nine-plus countries currently reviewing cultivated meat regulations [9]. In the UK, the Intellectual Property Office adheres to European Patent Convention rules, which permit patents on isolated cell lines and engineered scaffolds but exclude certain biological materials. When submitting novel food dossiers to the Food Standards Agency, companies must carefully distinguish between safety-related disclosures and proprietary information, explicitly requesting data exclusivity protections where applicable.

Without greater international cooperation on these issues, the cultivated meat industry risks replicating the same concentration of power seen in conventional agriculture - only this time, through the control of intellectual property rather than farmland.

5. Gaps in Regulatory Infrastructure

While many countries express support for cultivated meat, most still rely on outdated food safety laws designed for traditional agriculture. This leaves regulators without the tools, expertise, or frameworks needed to properly evaluate cell-cultured meat. The lack of specialised testing facilities, clear guidelines, and technical knowledge creates a significant challenge for the industry.

Singapore stands out as a leader in this space, becoming the first country to approve a cultivated meat product in 2020 after establishing a structured review process. Similarly, the United States introduced a joint FDA–USDA oversight framework in 2019 to coordinate regulation. However, many low- and middle-income countries, particularly in Africa, Asia, and Latin America, lack such systems. Without dedicated agencies, validated testing methods for materials like scaffolds or growth factors, and protocols for inspecting pharmaceutical-grade production facilities, these nations face steep regulatory hurdles. The disparity between countries with established frameworks and those still developing their capacity is stark.

In the United States, some states, including Florida, Texas, Alabama, and Nebraska, have gone as far as banning cultivated meat due to insufficient local regulatory systems. For instance, Believer Meats had to shut down its facility in 2025, citing regulatory challenges that stalled market readiness. Even companies with federal approval, such as Upside Foods, have faced obstacles; the company is currently suing Florida over its ban, with a trial scheduled for February 2026 [5][10].

To bridge these gaps, building regulatory capacity is critical. Agencies need training in areas like cell culture, bioprocess engineering, and contamination prevention - skills that are often lacking. International organisations, such as Codex Alimentarius, are becoming increasingly vital for countries unable to establish comprehensive regulatory systems independently. By mid-2025, cultivated meat products were under review in at least nine jurisdictions, but the absence of global standards leaves many nations dependent on international guidance to shape their food safety systems [8][9][11]. This highlights the importance of investing in infrastructure that aligns with global benchmarks.

Targeted investments and international cooperation are key to addressing these shortcomings. For example, in the UK, post-Brexit efforts by the Food Standards Agency to develop infrastructure and pursue mutual recognition agreements with countries like Singapore and the US provide a practical way forward. Such initiatives ensure high safety standards while enabling market growth. Additionally, organisations like The Cultivarian Society play a crucial role by fostering public dialogue and education, helping to establish evidence-based regulations in emerging markets.

Conclusion

The regulation of cultivated meat on a global scale faces five major challenges. These include inconsistent safety assessments, varied labelling requirements, trade barriers, disputes over intellectual property, and gaps in infrastructure. Together, these issues are slowing down the industry's development and its ability to reach markets effectively.

The path forward lies in international collaboration. Organisations like the Codex Alimentarius Commission, as highlighted in the FAO's 2025 report[9], could play a key role in creating aligned standards. Harmonised regulations would not only encourage innovation but also improve efficiencies in production and distribution. A coordinated, science-based approach is essential to overcoming these barriers and unlocking the potential for growth in this sector.

The need for action is pressing. Even with FDA and USDA approvals, companies like Believer Meats have faced setbacks, such as shutting down their facility in 2025 due to regulatory hurdles that delayed market readiness[4][5]. At the same time, 259 cultivated meat companies across the globe are waiting for clearer regulatory pathways to move forward[1]. By mid-2025, products were under review in at least nine jurisdictions, showing that momentum exists - but only if stakeholders act swiftly and decisively[9].

To address these challenges, policymakers, industry leaders, and organisations such as The Cultivarian Society must work together to establish science-based, unified standards. This collaboration is crucial to ensuring that cultivated meat can provide a sustainable and ethical alternative to traditional meat production.

The future of food hinges on unity rather than division. The time to take action is now.

FAQs

Why do safety standards for cultivated meat differ between countries?

Safety standards for cultivated meat vary around the world, shaped by each country's regulatory systems, scientific approaches, and levels of technological development. Regulations are often customised to fit local laws, cultural practices, and public perceptions of food safety.

These differences complicate efforts to establish universal global standards. Risk assessments and approval procedures tend to prioritise regional concerns, creating inconsistencies that can hinder international trade and cooperation within the cultivated meat sector.

How do inconsistent labelling standards impact the global trade of cultivated meat?

Inconsistent labelling standards can cause confusion for consumers and regulators alike, complicating the path for cultivated meat products to secure acceptance in global markets. When labelling varies, it can result in delays at borders, regulatory pushback, or even scepticism among potential buyers.

Clear, harmonised labelling plays a key role in ensuring that consumers understand what cultivated meat is, why it’s safe, and how it aligns with ethical considerations. Standardising labels can streamline international trade, making it easier for cultivated meat to enter more markets and contribute to a more sustainable food system.

What are the key intellectual property challenges faced by cultivated meat companies?

Cultivated meat companies encounter a range of intellectual property hurdles, particularly when it comes to securing patents for distinct cell lines, novel cultivation techniques, and advanced bioreactor technologies. These protections are critical for staying ahead in an industry that's advancing at breakneck speed.

Adding to the challenge is the need to navigate international intellectual property laws, which differ widely from one country to another in terms of regulations and enforcement. Companies must carefully balance protecting their innovations with adhering to these varied legal frameworks to minimise the risk of disputes or infringement claims.