CRISPR Products on the Shelf: How to Ensure the Safety of a New Generation of GMOs

Food shoppers around the world are beginning to find something new in their carts – foods made with CRISPR gene editing. These are being called a new generation of genetically modified organisms (GMOs), created not by inserting foreign genes, but by precisely tweaking organisms’ own DNA. How can we be sure these CRISPR-edited products are safe to eat? This article explores the rise of CRISPR foods, the regulatory steps major markets are taking to ensure their safety, and the scientific and transparency measures that underpin consumer confidence in this emerging food technology.

A New Era of Gene-Edited Foods on the Market

From longer-lasting mushrooms to heart-healthy tomatoes, CRISPR-edited foods are moving rapidly from labs to store shelves. Unlike first-generation GMOs, which often contain genes from other species, many CRISPR products involve small edits to an organism’s native genome – changes that could sometimes occur naturally. This has enabled several innovative foods to reach consumers:

• Non-Browning Mushroom (US): In 2016, a white button mushroom edited with CRISPR to turn off an enzyme that causes browning became the first CRISPR-edited crop declared outside of USDA regulation. By deleting a few base pairs in the mushroom’s genome (with no foreign DNA added), researchers created a mushroom that resists browning and spoilage. The USDA confirmed these CRISPR mushrooms did not meet its criteria for a regulated GMO since they contained no introduced genes. Notably, the developers also verified that no traces of the CRISPR-Cas9 machinery or antibiotic marker genes remained in the mushroom – a key safety check ensuring the final product was just a mushroom with a tiny deletion.

• Waxy Corn (US): Similarly, DuPont (now Corteva) used CRISPR-Cas9 to knock out a gene in corn (Wx1) to create a high-amylopectin “waxy” corn useful for starch products. USDA concluded this CRISPR-edited corn also escaped GMO oversight. The end product was biochemically equivalent to conventionally bred waxy corn, which helped it pass regulatory muster.

• High-Oleic Soybean Oil (US): In 2019, consumers in the Midwest unknowingly tasted the first gene-edited food product in the U.S. – a cooking oil made from Calyxt’s high-oleic soybeans. Calyxt used gene editing (via TALENs, a tool similar to CRISPR) to create soybeans with a healthier oil profile (higher monounsaturated fat) without introducing any foreign DNA. Calyxt’s oil (branded Calyno) became the first commercial gene-edited food, served in restaurant frying and salad dressings. It boasts zero trans fats and extended fry-life, and was deemed non-regulated by USDA under its plant pest rules. This early product demonstrated how CRISPR-style edits can make tangible improvements to foods while sidestepping the GMO label.

Gene-edited high-oleic soybeans were among the first CRISPR-era foods. By deleting a gene that saturates fats, developers created a soybean oil with a healthier fat profile – without adding any foreign genes.

• GABA-Enriched Tomato (Japan): In 2021, Japan introduced the world’s first CRISPR-edited food available to consumers: the Sicilian Rouge High GABA tomato. Tokyo-based Sanatech Seed used CRISPR-Cas9 to knock out genes that limit production of GABA, a naturally occurring amino acid, resulting in tomatoes with 4–5 times the normal GABA content. The company claims this could help lower blood pressure and promote relaxation. Japanese regulators reviewed the tomato and found its safety profile equivalent to a conventionally bred high-GABA tomato. These tomatoes were sold directly to Japanese consumers as a functional food, marking a milestone for CRISPR crop commercialization. Notably, Japan did not require a lengthy GMO approval process in this case; the product met criteria for exemption since no foreign DNA was inserted.

• CRISPR-Edited Fish (Japan): Gene editing isn’t limited to produce – Japan has also approved CRISPR-edited seafood. By 2022, Japanese markets saw faster-growing red sea bream and tiger puffer fish developed with CRISPR. A few small DNA tweaks gave these fish desirable traits (like increased muscle mass), allowing them to reach market size sooner. Japan’s regulators allowed these to be sold after developers registered the edits, again without treating them as transgenic GMOs.

• New Crop Varieties (China and Others): Other countries are rapidly following. China has historically been cautious with GMOs, but is now pivoting to gene editing to boost food security. In 2023–2024, China’s Ministry of Agriculture issued the first safety certificates for CRISPR-edited crops, including new soybean, wheat, corn, and rice varieties with traits like higher yield or nutrition. By the end of 2024 China had approved five gene-edited crop varieties (alongside several GM (transgenic) crops) for cultivation, signaling a major policy shift. The gene-edited lines – developed by national institutes and companies – are expected to improve oil content and disease resistance. These approvals are part of China’s strategy to reduce import reliance and ensure food security, although officials note they face lingering public skepticism about GMO foods.

• Global Trend: In addition to the U.S., Japan, and China, numerous countries have updated regulations to accommodate gene-edited foods. Argentina was a pioneer, establishing in 2015 a case-by-case process to exempt certain gene-edited plants from GMO regulation if no foreign gene is present. Brazil, Canada, Australia, the UK, and others now have similar policies that streamline approval for SDN-1 edits (simple mutations) while keeping larger genetic modifications under stricter review. The result is that CRISPR-edited products are poised to appear in virtually every grocery aisle, from healthier oils and biofortified crops to drought-resistant grains. As this wave builds, ensuring their safety is paramount.

Regulatory Watch: How Major Markets Oversee CRISPR Foods

Regulators around the world are grappling with how to manage CRISPR-derived foods. The challenge is to ensure safety and consumer confidence without stifling innovation. Different countries have taken notably different approaches:

• United States: U.S. oversight of biotechnology is shared between USDA, FDA, and EPA, using a product-focused approach. For crops, the USDA’s stance has been that if a plant could have been developed through conventional breeding (i.e. it contains no foreign DNA or plant pest sequences), it may be exempt from GM regulations. This is why the CRISPR-edited mushroom and corn described above “escaped” USDA regulation – the end-products had only small deletions, indistinguishable from natural mutations Similarly, USDA classified Calyxt’s high-oleic gene-edited soybeans as non-regulated in 2018. That said, U.S. agencies still scrutinize safety in specific cases: the FDA can review any food with novel compositions or allergens, and the EPA oversees gene-edited crops that produce pesticidal substances. In 2023, the EPA tightened rules for gene-edited plants with pest-resistant traits, requiring health and environmental data if a CRISPR edit generates a plant-incorporated protectant (such as a Bt-like insecticidal protein). But broadly, if a CRISPR-edited crop doesn’t introduce a new protein or risk (for example, it simply knocks out a gene or reproduces a known natural variant), it faces minimal pre-market hurdles in the U.S. This science-based, trait-by-trait approach reflects the FDA’s view that there is no intrinsic difference in risk between genetic engineering and conventional breeding – safety depends on the product, not the method. Notably, the U.S. has no mandatory GMO label for most gene-edited foods; the FDA does not consider gene-edited crops materially different in composition, so unless a nutritional profile changed or an allergen introduced, labeling is not required.

• European Union: The EU has historically applied the precautionary principle and strict regulations to GMOs, requiring extensive safety reviews by the European Food Safety Authority (EFSA) and traceability of any GMO ingredients In 2018, the European Court of Justice ruled that gene-edited organisms must be regulated as GMOs, meaning CRISPR crops currently face the same lengthy approvals and labeling rules as transgenic plants. However, recognizing scientific advances, the EU is now reconsidering this stance. In July 2023, the European Commission proposed a new regulation for “new genomic techniques” (NGTs), which would differentiate gene-edited plants based on the nature of the edit. Under this proposal, CRISPR-edited plants that could also occur naturally or via traditional breeding (for instance, a single mutation or cisgenic change within the gene pool of that species) would be classified as “Category 1 NGT” and exempted from the burdensome GMO approval process. They would be treated like conventional plants after a verification step, with no requirement for GMO labels on the final food. All other edits (more complex or transgenic edits, “Category 2 NGT”) would remain subject to full GMO risk assessments and labeling. This two-tier system aims to maintain high safety standards while easing restrictions on low-risk edits. It is not law yet – it must be approved by EU Member States and the European Parliament. As of early 2025, EU members were actively debating this change, with some pushing for even looser rules to spur innovation and others voicing caution. For now, any CRISPR-edited food entering Europe (e.g. imported products) technically requires GMO authorization and labeling, although enforcement is challenging if the edit leaves no unique DNA signature.

• China: China has traditionally limited GMO cultivation to a few crops, but is now embracing gene editing as a safer, more palatable tool for crop improvement. In April 2023, China’s Ministry of Agriculture and Rural Affairs issued its first safety certificate for a CRISPR-edited crop (a high oleic acid soybean). By the end of 2024, China had granted safety approvals to five gene-edited crop varieties, including new strains of soybean, corn, wheat, and rice. These edits aim to increase yields and nutritional quality. The safety certificate process indicates authorities do review data on the edits, but the process is faster and more streamlined than for transgenic GMOs. China appears to view gene editing as a strategic tool to boost domestic food production. However, regulators are moving cautiously in terms of public consumption – for instance, Chinese consumers currently mostly encounter gene-edited crops indirectly (as animal feed or processed ingredients), and direct sales of CRISPR foods to consumers have been limited so far. Public sentiment in China remains wary of genetically modified foods, so regulators have signaled that rigorous oversight and clear labeling will likely accompany any gene-edited foods in the retail market (China has long required labeling of GMO products, and gene-edited products may fall under similar rules to inform consumers). The evolving Chinese framework seeks to balance food security benefits of CRISPR with public reassurance that these foods are safe.

• Japan: Japan has positioned itself as a friendly environment for gene-edited foods by developing clear, innovation-friendly guidelines. In 2019, Japanese regulators decided that gene-edited organisms with no foreign DNA are not “GMOs” under law and do not require elaborate safety evaluations, provided developers simply notify the government about their edits. This opened the door for the GABA tomato and CRISPR fish mentioned earlier. The health ministry (MHLW) determined the CRISPR tomato was as safe as conventionally bred tomatoes. Developers had to register the product and demonstrate that no transgene was present and that only small, intended mutations were made. No special label was mandated, though Sanatech voluntarily marketed the benefit (high GABA) to consumers. Japan’s approach exemplifies a middle ground: oversight via notification and transparency, but no lengthy pre-market tests for simple edits.

  This approach, also adopted by countries like Australia and Argentina, relies on the idea that if the genetic change is minor and the product’s composition is not fundamentally novel, the risk profile is the same as a traditionally bred variety. Of course, Japan still requires GMO-style review for edits that introduce new DNA or larger changes – but so far, all CRISPR foods on the Japanese market have been of the simpler type (SDN-1 edits). Interestingly, despite Japan’s historically cautious public attitude toward GMOs, these gene-edited offerings have not triggered major public backlash – the media coverage has been mostly positive, and consumers see them as akin to fortified or improved foods rather than “Frankenfoods”.

In summary, a global trend is emerging: if a CRISPR-edited food is essentially the same as one created by conventional breeding, many regulators will fast-track it, subject to basic safety verifications. Major markets like the U.S. and Japan already treat such products leniently, and the EU and others are moving in that direction. However, each region is proceeding at its own pace, and anyone bringing a CRISPR product to market must navigate this patchwork of rules. Producers often tailor their approach to the strictest market – e.g. ensuring traceability and data in case EU approval is needed – which ultimately contributes to a higher safety standard globally.

Scientific Safety Assessments: What’s Done to Ensure CRISPR Foods are Safe?

Gene editing offers unprecedented precision, but no technology is foolproof. Ensuring the safety of CRISPR-derived foods involves a combination of laboratory diligence, rigorous risk assessment, and in some cases creative new testing methods. Key safety considerations include:

1. Checking for Off-Target Changes: CRISPR’s precision is high but not absolute – the Cas9 enzyme can sometimes cut at unintended genomic sites if there are partial sequence matches. Unintended mutations could, in theory, create a new allergen or toxin, or affect a plant’s nutritional profile. To manage this risk, developers now routinely perform whole-genome sequencing or other sensitive scans on edited plants/animals to identify any off-target mutations. If off-target edits are found, the affected breeding line can be discarded or re-edited to remove them.

For example, Japanese scientists verifying the GABA tomato sequenced the genome to confirm only the intended gene knockouts were present before commercialization. Many groups also design their CRISPR guide RNAs to be highly specific (using bioinformatics tools to avoid sequences that have close matches elsewhere in the genome). Additionally, using high-fidelity Cas9 enzymes and shorter guide RNAs can significantly reduce off-target cuts. These best practices mean that by the time a gene-edited crop is ready for market, it’s been through multiple rounds of “de-risking” at the DNA level, resulting in a plant that typically has just the intended genetic change. In essence, developers strive to make the final genome-edited product as if it were a naturally mutated organism with one new trait – nothing more.

2. Ensuring No Unwanted DNA Remnants: Another safety step is confirming that no foreign DNA sequences (like plasmid backbones or selectable marker genes) were accidentally left behind in the edited organism. Early gene-editing experiments often use DNA vectors or bacterial plasmids to deliver CRISPR components into cells. If part of a plasmid integrates into the genome by mistake, it could carry unwanted genes (for instance, antibiotic resistance genes used in the lab). This is not just a theoretical concern – in 2019, the U.S. FDA discovered that gene-edited hornless cattle created by a biotech company, Recombinetics, had inherited an unintended stretch of bacterial DNA, including antibiotic resistance genes. The editing process had inadvertently inserted a piece of the plasmid used to deliver the edit.

While regulators noted this particular foreign DNA fragment was not known to be harmful, it was a clear oversight and a wake-up call. It underscored that CRISPR editing, especially when using DNA vectors, can introduce extraneous material if not carefully controlled. In response, best practices now dictate that researchers thoroughly screen edited animals and plants for any trace of vector DNA. For plants, techniques like PCR and Southern blotting (or sequencing) are used to confirm that only the intended edit is present. (Recall the CRISPR mushroom case: the developers used PCR and Western blot analyses to verify that no Cas9 transgene or antibiotic marker was present in the final mushrooms.) Moreover, many developers are shifting to DNA-free editing methods – delivering the Cas9 protein and guide RNA directly into cells (or as a transient RNA), so nothing can integrate. This ribonucleoprotein (RNP) delivery method leaves no footprints: once the edit is made, the protein and RNA degrade, and there’s no plasmid involved. By using such approaches and conducting thorough molecular inspections, companies can ensure that CRISPR-edited foods contain exactly what they’re supposed to (the intended gene edit) and nothing they’re not.

3. Traditional Food Safety Evaluations: If a gene edit results in a noticeable change to the food (for instance, a nutrient level is enhanced), regulators and companies will often evaluate whether that change has any unintended side effects. This is analogous to the safety assessments done for fortified foods or novel crop varieties. For example, the high-GABA tomato naturally has much more of an amino acid than typical tomatoes. Japanese authorities examined data on the tomato’s composition to ensure other nutrients and metabolites were in normal ranges and that the elevated GABA itself didn’t pharmacologically pose a risk at dietary levels. In general, for gene-edited crops the same safety questions are asked as for any new food cultivar: Is it substantially equivalent to traditional varieties in key components? Are there any new allergens or toxins introduced?

With many gene-edited plants, the answer is straightforward because the edit might only alter one compound (like reducing a bitter element or increasing vitamin content) without introducing new proteins. In cases where a CRISPR edit does introduce a new protein (say, editing a plant to produce a drought-tolerance enzyme, or in future, if a CRISPR animal is engineered to express a novel trait protein), standard allergenicity and toxicity tests are required. Regulators like EFSA and FDA have well-established protocols for assessing GM crops, and they have indicated these apply equally to gene-edited products. In fact, the European Food Safety Authority published guidance as early as 2012 on assessing cisgenic and gene-edited plants, concluding that existing risk assessment frameworks for GMOs are generally applicable to gene-edited plants as well. This includes evaluating nutritional data, conducting animal feeding studies if needed, and analyzing any novel proteins.

4. Long-Term and Environmental Considerations: One oft-raised question is: what about long-term effects or ecological impacts of gene-edited crops? Here, experience from conventional GMOs provides some reassurance and a call for continued vigilance. A comprehensive 2016 report by the U.S. National Academies examined decades of data on GM crops and found no evidence of health risks to humans and no credible evidence of environmental harm directly due to the genetic engineering (beyond the impacts of the traits themselves, like herbicide use patterns). It noted that eating GM foods has shown no differences in health outcomes in animals or humans compared to non-GM foods. This suggests that genetic modifications per se, including precise edits, are unlikely to produce weird long-term health effects if rigorous pre-market testing shows nothing amiss. However, the same report cautioned that detecting subtle or long-term effects is inherently challenging, and that some risk assessment tools need refinement.

For CRISPR crops, environmental risk assessment focuses on familiar issues: Could the new trait make a plant invasive or toxic to wildlife? Might it cross-breed with wild relatives and confer an ecological advantage? Since many CRISPR edits are equivalent to naturally occurring variants, the ecological risk is usually judged low (for instance, a disease-resistant gene could spread, but such genes are often present in wild gene pools anyway).

Nonetheless, regulators may require case-by-case environmental assessments for certain traits – especially if a trait could affect ecosystems (e.g. a gene-edited plant with increased weediness, or a gene drive application in the future). So far, the CRISPR crops commercialized (like the tomato, soybean, etc.) have traits similar to those in existing breeds and have not raised novel environmental concerns. As a safety net, post-market monitoring can be instituted for any unforeseen issues, and some jurisdictions require developers to provide a method to detect the gene-edited crop in commerce (for tracking purposes), though detecting a single base edit is a technical challenge.

In short, ensuring the safety of CRISPR foods is about combining the precision of the technology with rigorous verification and testing. Developers must “measure twice, cut once” – design careful edits, then verify, verify, verify the outcomes. Regulatory scientists, in turn, evaluate the final product’s composition and characteristics, rather than the editing process itself, to decide on safety. The process is arguably more exhaustive than for many conventional new crop varieties (which can be released without any molecular characterization at all), highlighting the conservative approach taken with biotechnology. By the time a CRISPR-derived food is on your plate, a host of molecular analyses and safety checks have been performed to ensure it’s as safe as its traditional counterparts.

Horizon Scanning: Building Trust and Future Outlook

As CRISPR-edited foods move from novelty to normalcy, what’s on the horizon for food safety and regulation? A few key trends and challenges are emerging:

Balancing Innovation and Caution: Regulators will continue to walk a tightrope between fostering innovation and exercising caution. The early CRISPR products have mostly offered consumer or farmer benefits (longer shelf life, improved nutrition, etc.) with no apparent downsides, which helped them gain regulatory acceptance. But future edits might be more complex. For example, scientists are working on CRISPR-engineered plants that can capture extra carbon, or nitrogen-efficient crops that alter soil microbiomes. Ensuring safety for such traits may require expanding risk assessments to new parameters (like soil impact). Regulators are already discussing how to update guidelines continuously as CRISPR applications broaden. We are likely to see more adaptive regulatory frameworks – rules that can evolve as experience with gene-edited foods grows. For instance, the EU’s proposed two-category system for NGT plants is one attempt to future-proof regulation, so that low-risk edits aren’t held back by outdated rules while high-risk edits still get scrutiny. International bodies like Codex Alimentarius may also develop harmonized guidelines for gene-edited food safety, which could help align standards globally.

Global Trade and “GMO” Labeling Dilemmas: One practical challenge is how gene-edited foods will be labeled and perceived across different markets. If a U.S. farmer grows a CRISPR-edited soybean that is unregulated domestically, what happens when exporting it to a country that considers it a GMO? Such disconnects can create trade headaches. Analytical detection of a CRISPR edit can be impossible if no foreign DNA is present – you can’t test a bottle of oil and easily tell if it came from a gene-edited soybean or a conventional high-oleic soybean, since the oil contains no DNA and the genetic change in the bean might be as small as a single base pair.

This is pushing regulators toward information-based solutions: databases and documentation. The EU, for example, in its draft proposal suggests a public database and seed labeling for Category 1 gene-edited plants (those treated like conventional). The idea is to maintain transparency about which crop varieties have been edited, even if the final food isn’t labeled on the shelf. Japan similarly requires notification and public disclosure of gene-edited products. These measures will help with traceability and consumer right-to-know without stigmatizing the products. Nonetheless, some consumer advocacy groups argue that any gene-edited food should carry a label, so individuals can choose to avoid them if desired.

This debate is ongoing – the terminology itself is evolving. Many producers avoid the term “GMO” and instead label their products as “gene-edited” or “genome-edited” to distinguish from older GMOs. This isn’t just a PR move; it reflects a genuine scientific difference (no foreign gene in most cases) and can influence public perception. In Japan, for instance, the Sanatech GABA tomato benefited from being marketed as a genome-edited, health-promoting tomato rather than a “genetically modified” one. Japanese consumers have shown greater acceptance partly because of this distinction. In the U.S., the regulatory term for labeling is “bioengineered” and current rules likely do not require a bioengineered label for CRISPR foods that have no detectable novel DNA or protein. How these labeling policies play out will have a big impact on public acceptance and international trade of CRISPR foods.

Consumer Acceptance and Education: Ultimately, the success of CRISPR products will hinge on public trust. Food safety professionals, regulators, and companies can do everything right scientifically, but if consumers don’t buy in, the technology won’t flourish. Surveys show that public attitudes toward gene-edited foods are still being shaped. Many people are learning about CRISPR at the same time as these products appear, leading to understandable questions: “Is it really safe? Isn’t it too fast compared to traditional breeding? Are we the guinea pigs?” Building trust requires transparency and outreach.

As one scientific institute noted, a major reason for GMO skepticism has been lack of understanding and lack of trust in those developing and regulating the technology. To avoid repeating that with CRISPR, experts emphasize the importance of open communication: making data on safety publicly available, clearly explaining the differences (and similarities) between gene editing and past GMO methods, and highlighting the tangible benefits to consumers and the environment. For example, if a CRISPR crop reduces pesticide use or improves nutrition, those are points that resonate with the public.

There’s also an opportunity to involve independent academics and even citizen stakeholders in the dialogue – for instance, some companies invite outside experts to review their safety data to bolster credibility. Early indications are that when consumers see a direct benefit (like a healthier oil or a vitamin-enriched fruit) and understand that the product has been vetted for safety, they are more receptive. Japan’s experience has been instructive: the functional benefits of the GABA tomato were emphasized, and the government even registered it under a system for health-improving foods.

This framing, plus the transparent notification system, meant that the tomato’s launch was met with curiosity more than concern. In contrast, had the tomato been introduced secretively or without explanation, it could have backfired. The lesson: engagement and education are as crucial to “ensuring safety” in the public mind as the laboratory tests are in the scientific sense.

Continuous Monitoring and Improvement: The first wave of CRISPR foods will not be the last – they are opening the door to a plethora of “edited” crops and animals. With each new product, there is an opportunity to refine safety assessment techniques. For instance, as base editing and prime editing (next-generation gene editing tools) start being used in agriculture, new kinds of off-target analyses might be needed (since these tools can create different types of mutations). Regulatory science is gearing up accordingly.

We may see more post-market surveillance for unexpected outcomes – much like new drugs are monitored after approval. If a pattern of allergenicity or environmental issue were ever linked to a gene-edited product (none has so far), authorities would need a mechanism to investigate and respond (e.g., recalls or additional usage restrictions). On the positive side, accumulating data on gene-edited crop safety could also streamline future approvals.

If, say, dozens of CRISPR-edited tomatoes are introduced and all are found as safe as regular tomatoes, regulators might reduce the data requirements for certain standard edits. There is already an undercurrent of this: regulatory agencies have signaled that familiarity and history of safe use will guide their decisions. The more gene-edited foods successfully reach the market and gain consumer acceptance, the more normal the process will become.

Sanatech Seed’s genome-edited Sicilian Rouge tomatoes were launched in Japan as a high-GABA functional food. Transparent regulatory approval and public education about their health benefits helped build consumer trust in this CRISPR-derived product.

Looking ahead, it’s clear that CRISPR technology in food production is here to stay – and likely to grow rapidly. The goal for industry, regulators, and the food safety community is to ensure that growth is accompanied by rigorous safety standards and public transparency. Horizon scanning in this context means staying alert to the next set of challenges: detecting ever more subtle genetic changes, evaluating novel traits we haven’t seen before, and updating regulations to keep pace with science. It also means anticipating public concerns and addressing them proactively.

In conclusion, CRISPR-edited foods can be made just as safe as – or even safer than – conventional foods, but achieving that requires diligence at every step: careful design, thorough testing, smart regulation, and honest communication. Thus far, the evidence from major markets like the US, Japan, and others shows that we can put CRISPR products on the shelf safely. By learning from each new product and continuously improving oversight, the food industry can harness this powerful technology to deliver healthier, more sustainable foods – with safety as the foundation for consumer confidence.

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