The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. 

Background to the case

Monk fruit is a small, round fruit from the melon family, native to China.  It is prized for its sweetness, and is mentioned in records of Chinese monks as far back as the 13th century — hence the name “monk fruit”.  Monk fruit decoctions can be made from fresh or dried monk fruit and are consumed as hot and cold teas and infusions, and as an ingredient in other foodstuffs such as soups, stews, desserts, sauces, baked goods and breakfast cereals. 

Guilin GFS Monk Fruit Corporation (Monk Fruit Corp.) is a world-leading producer and manufacturer of monk fruit products, including monk fruit decoctions.  The company wished to market its products in Great Britain. It was not clear at that time however whether the products would be considered “novel food” or not, as no-one had comprehensively examined monk fruit’s history of consumption in Great Britain at that point.  Where there is uncertainty about the novel food status of a product that a food business operator (FBO) intends to place on the market in Great Britain , the Novel Food Regulation (Retained Regulation (EU) 2015/2283) requires the FBO to verify with the FSAs whether the food is “novel”.  Broadly speaking, a food is novel it was not used for human consumption to a significant degree within the EU or UK before 15 May 1997.  If a food is novel, it must be approved by the authorities based on safety checks before it can be marketed. 

Evidence of consumption of monk fruit

Monk Fruit Corp. compiled a dossier of evidence demonstrating monk fruit’s history of consumption in Great Britain.  Monk Fruit Corp. considered the European Commission’s guidance on determining a significant history of consumption (Guidance).  To help FBOs gather evidence, the Guidance sets out a table (Table 3) of different types of evidence that could show a history of consumption (e.g. sales invoices; official documents; personal testimonies), as well as possible evidentiary weight that one could ascribe to that evidence (e.g., very good evidence; good evidence; supporting evidence).  However, the Guidance makes very clear that these weightings are merely examples, and that it “does not provide an exhaustive list of relevant criteria to be considered for determination of the novel food status… In fact, each product has to be evaluated on a case-by-case basis.  A specific criterion might be not applicable in one case but of significant value for another product.”  The Guidance also explicitly acknowledges that, given the passage of time since 1997 (the ‘cut‑off date’ for history of consumption), some forms of evidence of consumption may no longer be available.  As such, “alternative sources of information should be considered”, and “the ‘whole picture’ needs to be examined”. 

Monk Fruit Corp. had not been able to secure comprehensive pre‑1997 sales information for monk fruit.  This was not surprising:  when Monk Fruit Corp. assembled the dossier in 2019, these records would have been more than 20 years old.  The records would also have come from an era before the mass digitization of sales records — there were no electric ‘back‑up’ files for the paper records.  Instead, Monk Fruit Corp. — following the Guidance — considered alternative sources of information, and examined the whole picture.  Ultimately, the dossier included evidence from a qualitative study of 71 Chinese FBOs, such as Chinese supermarkets, wholesalers, distributors, importers and monk fruit consumers; evidence from a systematic quantitative population sample survey of 1,153 people living in the UK of Chinese origin or descent; and various other signed declarations and statements from restaurant owners, FBOs and the London Chinatown Chinese Association, all confirming Monk Fruit Corp.’s position that monk fruit was consumed in the UK to a significant degree before 15 May 1997.  Based on average consumption patterns, it was estimated that 5.2 million servings of monk fruit products were consumed as food in 1996 alone.  Projecting further backwards in time, it was estimated that 56.4 million servings of monk fruit decoctions were consumed as food between 1980 and 1996. 

Judicial review of FSA’s decision

Despite the FSAs finding that the studies submitted were “robust”, the FSAs issued decisions that the monk fruit decoctions were novel on the basis that the company’s dossier did not show sufficient history of consumption.  Monk Fruit Corp. applied for a judicial review of the decisions. 

On March 19, 2024, Mr Justice Calver gave judgment in favour of Monk Fruit Corp.  The judgment examines the FSAs’ decision‑making process in detail.  Calver J found that the FSAs had rigidly applied the EU’s guidance on weighting of evidence instead of considering “the whole picture”.  The Court found that the FSAs took the position that if a company could not present the type of evidence described in the Guidance as “good” or “very good evidence” (e.g., comprehensive sales information pre-1997), then the company could never demonstrate a significant history of consumption of a food, regardless of the quantity or strength of its alternative information.  Calver J also found that the FSAs had incorrectly imposed a requirement that Monk Fruit Corp.’s evidence be independently verified.  This is not a requirement imposed by the Novel Food Regulation (and it was ultimately unclear what independent verification would look like, in the context).

Calver J found that the FSAs’ approach to the novel food assessment was therefore wrong in law.  Calver J was also critical of the FSAs’ consideration of Monk Fruit Corp.’s statistical evidence.  On that basis, Calver J quashed the decision, and ordered the FSAs to re‑consider Monk Fruit Corp.’s dossier in light of the judgment and addition information brought forward during the proceedings.  The judgment is available here: https://caselaw.nationalarchives.gov.uk/ewhc/admin/2024/614.

Brian Kelly, and Seán Finan of Covington & Burling LLP and David Scannell KC and Malcolm Birdling of Brick Court Chambers represented Monk Fruit Corp.

Photo of Seán Finan Seán Finan

Seán Finan is an associate in the Life Sciences team.  His practice covers environmental, food and beverage and pharmaceutical regulation. 

Seán has specific experience in a number of key areas for EU and UK clients in the food and beverage, pharmaceutical, cosmetic and…

Seán Finan is an associate in the Life Sciences team.  His practice covers environmental, food and beverage and pharmaceutical regulation. 

Seán has specific experience in a number of key areas for EU and UK clients in the food and beverage, pharmaceutical, cosmetic and consumer goods industries, including:

  • General food regulation; novel food regulation; genetically modified and “precision bred” products;
  • Advertising claims, particularly environmental claims and “greenwashing”;
  • Environmental and ESG compliance issues (Extended Producer Responsibility, ); and
  • Chemicals legislation (REACH, CLP, Biocides).

Seán is qualified in both England & Wales, and the Republic of Ireland.

Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.