Factors contributing to the delay include parliamentary timetables, election periods in devolved nations and the ongoing Food Standards Scotland (FSS) consultation on the safety, labeling and authorization of CBD novel foods.
The December meeting minutes reflect board members’ concerns that deprioritizing novel food cases, specifically CBD, could create a “frozen market” that stifles competition.
Authorizations have been pushed back to the fall, by which point the board expects it will have “revisited its prioritization framework”, due to anticipated progress in Sanitary and Phytosanitary (SPS) mutual harmonization negotiations.
Industry experts have already warned the proposed harmonization could lead to the UK adopting stricter EU CBD legislation if those mandates are introduced before CBD products are authorized in the UK.
Mark Tallon, PhD, managing partner of food law firm Legal Foods, commented that the reasons given in the minutes for this further delay in authorizations did not appear genuine, sharing that he predicts the FSA will delay the vast majority of CBD applications from receiving ministerial approval.
“The outcome will be pushing applicants into a continued holding pattern—non-authorized but tolerated—and then move off to EFSA [European Food State Authority] to deal with,” he said, noting that EFSA’s strict requirements would likely result in the loss of more businesses or market consolidation.
He predicted the majority would be rejected on the basis of characterization as they would not have the funds or resources to meet EFSA requirement for nano assessments or to fill the gaps in reproductive toxicity.
He added: “This is such a sad state of affairs, and we should all consider if promises made by UK regulators can be trusted in the future. Simply blaming SPS Agreement for the current state of non-approvals is not good enough.”
Referring to the protracted CBD Novel Foods process, ongoing since 2021, he said that there has been “five years of a scientific experimentation on the UK public with CBD isolates” without an increase in CBD related birth defects or cases of hepatotoxicity.
“It will be interesting to see if dynamic alignment trumps regulated product exemptions for those investing hundreds of thousands in UK submissions,” he added.
So how did the market end up in a situation in which the rest of Europe is tightening CBD regulation while the UK has remained in a long-standing grey area of tolerated but not authorized products?
The answer lies in a series of regulatory changes that have unfolded since CBD was classified as a novel food in 2020.
2020: Legislation to end legal haze
In a market of flourishing CBD innovation and exploding consumer interest, FSA announced in February 2020 that it was going to regulate CBD as a novel food product.
“CBD products are widely available on the high street but are not properly authorized,” said Emily Miles, chief executive of the FSA, at the time. “The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or products will be taken off shelves.”
Rather than banning all CBD products, the agency set a deadline of March 31,2021 for businesses to submit novel food application dossiers.
Products with valid applications were to be catalogued on a ‘public list’ while processing through to authorization, providing businesses time to comply while ensuring that they were held to safety standards.
FSA advised that any product brought to market after Feb. 13, 2020 would be considered illegal until granted novel foods authorization. Products placed on the market before this date and linked to novel foods applications under review could remain on the market until a final authorization decision was reached.
The process was expected to finally clear the legal haze in one of the world’s most dynamic CBD markets. Most CBD firms and trade groups welcomed the deadline as something that would bring much-needed regulatory clarity, making the UK the first territory to officially regulate CBD as a food product.
Companies turned their attention to the expensive task of rapidly compiling dossiers to meet European Union-determined safety and efficacy demands.
At the time, Dr. Tallon raised concerns over the FSA’s seemingly arbitrary Feb. 13, 2020 cutoff, pointing out that products on the market before that date might have no safety data yet still be considered legal, while products sold after that—even with a full suite of toxicology data—could be considered illegal.
The FSA expected product authorizations would take place at the end of 2023 or the beginning of 2024.
2021: Nurturing or neutering the market?
When the agency revealed its first long awaited, but strikingly short, public list of CBD products in April 2021, the industry began to murmur.
The list contained just 22 products, all CBD isolates, from just three companies: Chanelle McCoy Health (Pureis), Cannabis Pharma s.r.o and Health Innovations (UK) ltd.
Daniel Pérez Vidal, founder of the online CBD retail platform For the Ageless, said at the time that 70% of his customers favored full-spectrum products, which contain CBD alongside other terpenes and cannabinoids that work together to produce an ‘entourage’ effect.
With the novel foods regulations working to weed out products containing THC and the first products to make the public list all being isolates, Vidal suspected the process would remove full-spectrum products from the market.
“We are worried the market runs the risk of becoming over-regulated, to the point of neutering itself in what it can offer,” he said.
Phil Culbertsons, MD at CBD manufacturer Love CBD, agreed. He predicted the market would become dominated by the big firms which could afford to do the toxicology studies and create the dossiers. He said he had already seen several producers exit the space as a result.
“The process of aligning themselves with the new legislation has been crushing,” he added.
2022: ‘Nonsensical’ public list
The following April saw the release of a far more substantial list of 3,536 products, hailed by the Association for the Cannabis Industry as a "major milestone for the UK’s CBD category.“
But several brands not included on the list were pulled from shelves, prompting complaints from businesses that their products were manufactured by companies on the list. In response, the FSA extended its deadline for additional dossiers submissions, noting that there would be no additions made to the list after June 2022.
Dr. Tallon described the list as “discrimininatory and nonsensical” and argued that the FSA should completely remove all CBD products from the market to ensure proper implementation of the novel foods regulation.
Dr. Mike Barnes, chairman of the Cannabis Industry Council, commented that the process had already damaged the industry.
“The whole thing has been a shambles, badly done, and it has put the industry in a state of limbo for two years,” he said, noting that while the market needed cleaning up, this was “really using a sledgehammer to crack a nut”.
A further 2,446 products were added to the list in April. The FSA acknowledged that 700 products had been ommitted due to a clerical error and included another 1,700 products after brands provided additional evidence. This left a balance of around 900 dossiers to process through to final authorization.
2023: ‘Slow rather than swift death’
With brands unable to innovate and extremely restricted in their ability to market products while they awaited formal authorization, the industry grew frustrated. Brands, suppliers, customers, retailers and investors took issue with the legal uncertainty, with the latter perhaps having the most impact on the industry.
Steve Moore, founder of the Association for the Cannabis Industry, warned that many in the industry were struggling to survive and noted his concern that the FSA was unlikely to be able to authorize any products before the determination of a legally permitted limit for THC.
“Investors are losing confidence in the regulator’s approach and the market in general,” he warned.
While he commended the FSA for its attempts to keep products on the market while processing applications, he said it had “perhaps led to a slow rather than swift death” for the industry.
CBD brands came out in force in October 2023 to refute guidance from the FSA, recommending that adults should limit CBD consumption to 10 mg per day, rather than 70 mg.
The agency said its newly recommended acceptable daily limit was based on evidence from the industry and updated advice from its independent scientific and toxicity committees.
Most CBD drinks on the market at that time contained at least 12.5 mg of CBD per can.
While continuing to limited clarity on the legal obligations of brands and retailers, the FSA stated that consumers “should check labels and consider their daily intake in light of this updated advice.”
Brands’ biggest worry materialized when Holland & Barrett temporarily removed 31 CBD products from its shelves before reinstating them once it became clear the limit was not legally binding.
Less than two weeks later, the UK Government accepted a recommended legal THC limit for CBD products of no more than 50 micrograms per unit of consumption. It further accepted recommended standardized analytical methods for the testing of products. This provided some clarity, and experts hoped it would support the formal authorization of applications.
2024: Hurry up and wait
In the spring of 2024, the FSA Scientific Committee issued its first two safety endorsements to dossiers submitted by Cannaray Brands and Chanelle McCoy, indicating that the companies had fulfilled the rigorous safety criteria necessary to progress to formal authorization.
The update raised continued hope that formal authorizations were on the horizon. Shomi Malik, commercial and strategy lead at the white label CBD supplier B3Labs, said at the time that it was “massive news for the industry after a seemingly never-ending saga.”
But few updates followed.
The end of the year brought an announcement from the FSA that it would align with the Home Office on safety assessments, risk management and compliance protocols.
This meant adopting strict THC thresholds of 1 mg per container for each controlled cannabinoid, creating significant restrictions and legal hurdles for the industry.
Luca Bucchini, managing director at Hylobates Consulting Srl, recognized the update as a necessary step towards clarity and full legal recognition of CBD in the UK.
“The Home Office’s views are not ideal for the industry but do provide a way forward with more legal uncertainty,” he said at the time.
2025: Increasing scrutiny in EU
In summer of 2025, the European Commission published negotiating mandates related to the “dynamic alignment” of Sanitary & Phytosanitary (SPS), a framework requiring the UK to align its rules with EU legislation to create a common SPS area.
While the mandates aim to streamline trade and reduce border friction, Dr. Tallon warned the UK would “become a rule taker, not maker” with potentially huge impact on the UK CBD market.
“Does this mean CBD and many other applications may never gain approval under the UK system or will they be signed-off before we get the SPS agreement in place?” he asked.
But others remained hopeful. Eoin Keenan, co-founder and CEO or CBD drinks firm Goodrays, said he believed the CBD authorizations would happen before the SPS mandates were finalized.
“The FSA are nearly at the finish line with the authorization process, so it just wouldn’t make sense to row back on that, particularly as its one of the fastest growing sectors in the UK and the whole point of the SPS draft is to stimulate trade,” he noted.
In July, nearly two years after announcing its acceptable daily CBD limit of 10 mg/day, FSA began to advise businesses to reformulate products to comply.
It also indicated that market authorization for CBD products in the UK was expected to be finalized by early 2026.
Just two months later, EFSA released a safety assessment on CBD, outlining several remaining data gaps and proposing a safe daily intake of 2 mg/day.
Jérôme Le Bloch, PhD, head of scientific affairs at FoodChain ID, expressed concerns about EFSA’s process, including its lack of transparency, methodological shortcomings and questionable basis for a ‘very restrictive’ limit.
While the authority’s opinion had no immediate legal effect, EFSA would use it as a reference point in ongoing novel food evaluations.
The authority has terminated multiple CBD novel foods applications since.
Later in the year, EFSA released a negative response to a CBD novel food application, citing to a lack of full identity characterization, stability data, genotoxicity studies, reproductive and developmental toxicity data, and human clinical safety data.
Dr. Tallon warned EFSA is looking for a a level of safety data beyond the norm.
“EFSA expect, in our view, an extended generation study related to reprotoxicity,” he said. “This million-dollar study is almost unmatched in prior EFSA opinions and suggests either a new level of restriction or a political push to have CBD not accepted as a food, irrespective of the data.”
He warned this would result in companies placing illegal product on the market and not engaging with regulators and risk assessors.
“We are talking about foods here, not medicines, and they should be assessed as such,” he said.
2026: EU alignment foreboding
With the EU maintaining strict control of CBD products and dynamic alignment mandates due in 2026, the window for CBD authorizations is narrowing, as industry players wonder whether EU alignment or the UK’s CBD market will prevail.
