Consultation outcome

Summary of stakeholder responses: consultation on CBD novel food authorisation

Updated 3 September 2026

This page provides an objective summary of responses to the consultation on applications for authorisation of 3 CBD food products as novel foods, setting out the range and balance of views expressed across stakeholder groups and the main themes raised.

It is descriptive rather than evaluative and is intended to show what respondents said, using percentages and selected anonymised quotations where helpful to illustrate key points.

This page forms the evidence base for the policy considerations and recommendations set out in the consultation outcome.

The consultation outcome outlines the next steps in the authorisation process, including how the Food Standards Agency (FSA) will use consultation evidence to inform its advice to ministers and the further guidance and implementation work planned, following any decisions.

Introduction

The FSA consulted on proposals to recommend authorisation of three isolate based cannabidiol (CBD) applications as a novel food, under specified conditions. 

The consultation drew responses from a wide range of stakeholders including industry, applicants, trade associations, local authorities and individual consumers.  

Responses reflected diverse views on topics including the acceptable daily intake (ADI), labelling requirements, protection of vulnerable groups, the categorisation of CBD food supplements, the Public List, and data protection provisions. 

Overall, respondents engaged in detail with both the scientific basis of the proposals and the practical implications for implementation, signalling strong interest in the future direction of CBD regulation in the UK.  

At the time of publication, no decisions have been made on the authorisation of the CBD products covered by this consultation.

The FSA’s role is to consider the consultation evidence alongside the scientific and regulatory assessments and provide advice to ministers in England and Wales. Ministers are responsible for making the final decisions on whether to authorise these applications. 

In developing its advice, the FSA has been guided by a set of agreed Board principles. These principles provide a consistent framework for decision-making and underpin the risk management choices reflected in the proposed terms of authorisation.

They are referred to in section 2 of the consultation summary, where stakeholder responses and proposed changes are discussed in detail. The principles are set out below.

Consumer safety

The FSA’s primary objective is to protect public health by ensuring consumers received clear advice on the safe consumption of CBD. 

Proportionality

The FSA will ensure that its recommendations on CBD to protect public safety are evidence-based and proportionate, whilst not disproportionately limiting consumer choice or the CBD industry. 

Ensuring compliance

CBD is subject to the same legal requirements as other novel foods. Once assessments of applications are complete, only CBD products linked to an authorisation should be on the market. 

Supporting enforcement

The FSA will ensure decisions made on the CBD public list, and recommendations on authorisation, support effective enforcement by enabling retailers and enforcement bodies to identify and address non-compliant products. 

Maintaining trust

The FSA’s approach to CBD will maintain consumer trust in food safety and the FSA through appropriate management of legal, operational and reputational risks to the agency.

Statistics

The consultation ran for 12 weeks from the 28 August 2025 to 20 November 2025. The FSA received a total of 46 responses. 

38 of the responses were received through the consultation form, and the remaining 8 were received via email. 

19 of the responses were from individuals and 27 were from organisations and included local authorities, CBD industry, and applicants and trade associations.

Category	Number of responses	Percentage of responses
Individuals	19	41%
Local authorities	4	9%
CBD industry	10	22%
CBD applicants	6	13%
Trade associations	6	13%
Other (Government Chemist)	1	2%
Total	46

Of the 46 responses, the majority were located in England – 28 (60%). 

Of the remaining 18 responses, locations varied and are captured in the below table. The categories and groupings below reflect how respondents described themselves in their submissions. No additional grouping has been applied, and responses are presented as received. 

The consultation was open to respondents from any country, and no additional weighting has been applied to respondents from within the UK.

Location	Number of responses	Percentage of responses
England	28	61%
UK (unspecified)	3	6.5%
Wales	2	4.3%
Other (Scotland)	2	4.3%
Germany	2	4.3%
USA	1	2.2%
Austria	1	2.2%
England and Wales	1	2.2%
Europe (unspecified)	1	2.2%
Other (Ireland and USA)	1	2.2%
Other (Republic of Ireland)	1	2.2%
Other (Netherlands)	1	2.2%
Other (Wales then England)	1	2.2%
NA	1	2.2%

Overall support or concern for authorisation

Volume of responses was generally higher than normal in the context of consultation on market authorisations and included individuals as well as organisations linked with, or impacted by, the CBD industry. 

Responses provided by organisations were generally provided by bodies representing large groups of members or associates, and therefore their responses can be taken to be representative of the collective views of their members.

Although the total of 46 responses is relatively high for a market authorisations consultation, this is still relatively low in terms of wider government consultation.  

Across stakeholder groups there was broad overall support for authorising CBD under the proposed conditions. Industry respondents in particular expressed clear backing for authorisation, with around two thirds of all respondents (68%) supporting the proposals.

These respondents highlighted benefits for consumer safety, market stability, and greater legal and regulatory clarity. Several industry respondents considered the UK to be well positioned to become a global leader in regulated CBD products, with authorisation providing clarity that could boost innovation. 

Alongside this support, respondents also highlighted notable concerns. Many questioned specific aspects of the proposed terms of authorisation including:

• the proposed labelling provisions relating to the FSA’s provisional acceptable daily intake (ADI) of 10mg/day
• the proposal to set a maximum permitted level of CBD at 10mg/day, aligned with the current ADI, as a condition of authorisation
• the breadth and practicality of the remaining proposed labelling requirements, including warnings for vulnerable groups and under 18s
• the impact of data protection provisions and the public list on market fairness 
• operational pressures for enforcement bodies

Alongside the above, over a third of respondents (37%) emphasised the need for clear transitional arrangements and timelines to help avoid market disruption.  

A smaller number, primarily individual consumers, opposed authorisation altogether citing safety fears, unease about associations with cannabis, or uncertainty regarding the perceived benefits of CBD. 

These respondents tended to call for stricter limits, zero THC requirements, or no authorisation. 

Overall, responses suggest broad acceptance of the authorisation but raise a range of practical issues and concerns about implementation. 

The section that follows summarises stakeholder responses in more detail and outline the proposed changes to the terms of authorisation in relation to the key issues raised.

Key Themes Raised

Labelling

Labelling was one of the most widely discussed areas of the consultation.

A majority of 56% responses supported the labelling proposals, recognising the importance of clear consumer information on the ADI, cumulative intake, and suitability for vulnerable groups.

Many respondents including individuals, trade bodies, enforcement bodies, and the CBD industry considered these measures proportionate to the known risks and essential for ensuring safe and informed use.

However, respondents within the industry, mainly applicants and trade bodies, repeatedly emphasised practical barriers to implementing the proposed wording. 

Applicants noted that the warning text is lengthy and would be challenging to fit on small product formats without compromising other mandatory information such as ingredient lists and allergen declarations.

The need for clear and prominent labelling was also highlighted, with concerns that overly dense or technical labels risk discouraging consumers from reading key information.

Respondent: “The proposed warning text is notably lengthy… It will be extremely difficult to fit the full text on pack without compromising essential product information.”

Industry stakeholders and applicants strongly supported cumulative intake messaging but responses from enforcement bodies and individual respondents were more divided on whether labelling alone would ensure the ADI is not exceeded. 

Twenty-one responses (46%) focused specifically on the role of the ADI related labelling in supporting safe cumulative intake. 

Several responses from local authorities pointed out that some current product formats, for example, drinks, confectionery and gummies, already exceed the proposed maximum level of 10 mg in a single serving, raising the risk that consumers will unknowingly exceed the daily limit even if they follow on pack instructions.

Others stressed that labelling inconsistencies across product types could undermine consumer understanding and result in confusion when comparing supplements, confectionary, and beverages.

Suggestions across responses to address these challenges included simplified wording, the use of QR codes or peel and read labels to relieve space pressure, and supplementary FSA consumer advice to reinforce safe use messages.

Enforcement bodies added that unnecessarily technical or medicinal sounding wording could blur the boundary between foods and medicines, lead to misinterpretation, or create compliance complications. 

Despite these issues, many respondents felt the overall approach to ADI communication was proportionate and practical, suggesting that consumers should also take some responsibility for following usage guidance when products are adequately labelled.

Respondent: “You can only label; consumers have to take some responsibility… we cannot regulate people and their behaviours.”

Nonetheless, there remained a strong consensus that cumulative intake, clarity of messaging, and consistency across product types are essential if labelling is to support safe and informed consumer choices. 

Respondent: “I don’t mind authorisation per se. However, detailed and sufficient labelling must be provided so that consumers can make informed decisions and avoid products if they wish to do so.”

The acceptable daily intake (ADI)

The FSA has previously established an ADI of 10mg/day CBD for healthy adults as part of its consumer guidance with respect to CBD. This guidance advises that healthy adults should limit their consumption of CBD from food to 10mg per day, which is about 4-5 drops of 5% CBD oil. 

Establishing 10mg/day as a maximum permitted level would place a legal requirement on Food Business Operators to present CBD food products containing the novel foods in such a way that would allow consumers to adhere to the FSA’s consumer guidance on consumption of CBD.  

The proposed condition of use generated some of the strongest and most detailed feedback across the consultation. 

Applicants and trade associations respondents argued that the proposed maximum permitted level is overly conservative, highlighting that it is based on a 70 kg adult and that this ’one size fits all’ approach does not account for variability in body weight and real-world consumption habits. 

Some instead suggesting that a weight based or tiered approach to determine maximum intake levels would be more appropriate. A smaller number of applicant respondents proposed alternative intake limits, such as 17.5 mg/day which they considered more closely aligned with available data. 

Comments relating to wider changes to the ADI itself are considered further in the out-of-scope section. 

Respondent: “The ADI is absurdly low and there is no credible evidence of any significant risk to health even at far higher levels.”

A theme across responses was the reduction from the previous FSA consumer advice of 70 mg/day to the proposal to set a maximum permitted level of CBD at 10mg/day as a condition of authorisation.

Responses from trade associations and applicants questioned whether the evidence underpinning this change was sufficiently transparent, particularly given the reliance on confidential toxicology data provided. They expressed a desire for clearer communication about how specific studies informed the recommended limit. 

International comparisons were also frequently raised by applicants noting that other jurisdictions allow higher limits. 

Trade bodies highlighted the European Food Safety Authority’s (EFSA’s) position of proposing a lower ADI of 2 mg/day emphasising the need for clear communication to Ministers and stakeholders to explain the scientific rationale for the UK’s position due to possible divergence from international standards. 

Respondent: “Current recommended ADI seems to be at odds with Canada and Australia who have a much higher ADI.”  

Respondent: “EU provisional ADI… 2 mg/day… safety cannot be established for individuals under 25… differences must be considered and  potentially explained… will result in different regulatory outcomes between GB, EU and NI.”

Practical concerns about the ADI were raised from individuals, enforcement bodies and the wider CBD industry including applicants around whether consumers understand the importance of cumulative intake of multiple CBD products in a day. 

These concerns were linked closely to widespread calls for additional consumer education, guidance alongside ADI messaging, and consistent compliance and enforcement of the ADI.  

Finally, industry respondents emphasised the wider economic and operational implications of the ADI, including potential product removals, need for reformulation, and the associated burden on both businesses and enforcement agencies.

Many called for clear transitional plans to support industry adaptation and avoid unnecessary disruption to the CBD market. 

Alongside these concerns, many respondents including consumers, trade bodies and several local authorities expressed their support for the 10 mg/day limit. 

They described it as precautionary but a proportionate approach that reflects the current uncertainties in the evidence base, especially regarding long-term use, vulnerable groups, and combined product consumption. 

Supportive respondents also noted that consumers ultimately retain agency over their intake choices but did stress the importance of effective cumulative intake messaging and consumer guidance to ensure consumers understand how to apply the ADI in practice. 

Respondent: “Clear labelling… together with an explicit warning… should be sufficient for consumers to make the correct choice.”

Overall, consultation feedback shows broad recognition of the importance of providing clear consumer advice on CBD consumption to support consumer safety, but there was significant disagreement about whether the maximum permitted level of 10 mg/day is the most appropriate level.

While there is strong support for clear labelling of the ADI messaging, respondents expressed diverse views on its scientific basis, international alignment, and practical implementation highlighting the importance of transparent communication as the market and science evolves.

Food supplements

Feedback on the proposal to authorise CBD within the food supplements category was generally positive.

In total, 23 respondents gave detailed feedback on this aspect of the proposal, with 16 of those responses supporting this route. 

Industry responses from trade associations and applicants emphasised that it aligns with current consumer expectations and provides a clear, stable and well-regulated framework for labelling requirements and enforcement. 

Some responses from applicants made comparisons of food supplements and wider food categories and considered food supplements preferable to wider food categories because dose control is more predictable and packaging formats discourage excessive consumption. 

Food supplements were widely viewed as one of the most highly regulated food categories, offering structured labelling requirements and established enforcement mechanisms that support consumer protection.  

Respondent: “Food supplements category is the best category… one of the most highly regulated food categories… appropriate for CBD products.”  

Respondent: “Authorising CBD as a novel food in the category of food supplements is not inherently misleading… authorisation relates to safety, not physiological effects… ensures consumers receive mandatory information.”

However, responses also captured concerns about whether CBD truly fits the definition of a food supplement, noting that CBD has no nutritional value and raising questions regarding the evidence for physiological effects. 

Responses from local authorities and individuals warned that classifying CBD as a food supplement could blur boundaries between food and medicines, particularly where products continue to be marketed with implied therapeutic or medicinal benefits. They highlighted the risk that consumers may misinterpret authorisation as an endorsement of therapeutic benefits. 

Enforcement bodies warned that the food supplement classification could set a precedent for allowing substances with no established nutritional effect into food supplements. This concern was amplified across the consultation responses with many highlighting unlawful health claims being made within the CBD sector. 

To mitigate risks, strict enforcement of health claims rules, clearer guidance for businesses, and consistent messaging to distinguish between foods, food supplements, and medicines were recommended by enforcement bodies. 

Responses from the CBD industry also expressed that additional guidance would be beneficial and welcomed, both for consumer clarity and for regulatory certainty.  

Overall, while the majority of responses supported maintaining CBD within the food supplements category, concerns about consumer misunderstanding and blurred regulatory boundaries were raised.

Across stakeholder groups there was a call for clear labelling, and strong consumer guidance and robust enforcement of existing restrictions on medicinal claims to address ongoing concerns to ensure safety and support informed choice for consumers.

Some respondents also highlighted that views on categorisation were closely linked to how consumers interpret and use CBD products, raising broader issues of consumer misperception that is explored in the following section.

Consumer misperception

Some respondents linked views on authorising CBD as a food supplement to broader concerns about consumer perception and behaviour.

While many considered the food supplements category to be in consumers’ interests, there was agreement that robust guidance, enforcement and consistent messaging would still be required to prevent consumer misperception and ensure that authorisation improves, rather than complicates, consumer understanding.

Several respondents noted that authorising CBD as a food supplement could reinforce existing misunderstandings, given that CBD has no nutritional value. 

Respondent: “There is potential for consumers to be misled by authorising the novel foods in the category of food supplements, if they are not a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect.”

Concerns about consumer understanding featured prominently across responses. A significant proportion of respondents warned that authorisation could create or reinforce perceptions that CBD products are medically beneficial, nutritionally advantageous, or entirely risk-free.

Some noted that authorisation could contribute to assumptions that products are appropriate for medical use, particularly where existing marketing already presents CBD as addressing a wide range of conditions. 

Stakeholders emphasised the importance of clear communication distinguishing food supplements from medicines, address misleading health claims, and supporting informed consumer decision-making. 

Respondent: “The claims made by CBD retailers give the impression CBD is a panacea for a whole encyclopaedia of ailments. Further regulatory approval may mean retailers use authorisation to further mislead consumers by giving a veil of legitimacy.”

Some respondents highlighted that product format can influence consumer behaviour.

Food supplements were seen by some as better understood as requiring controlled intake, supported by clearer dosage instructions and warning statements, helping reinforce adherence to the ADI.

By contrast, wider food categories such as drinks and confectionery were viewed by some as increasing the risk of misperception, as every day or ‘treat’ formats may weaken associations with dosage control, reduce attention to warnings, and increase the likelihood of inadvertent overconsumption.

Concerns were also raised that such formats could contribute to normalisation and increased appeal to children and young people. 

In contrast, some applicants and trade associations considered that risks of consumer misperception could be managed through clear labelling, portion control and strict limits on CBD content, provided these requirements were effectively enforced. 

Separately, enforcement bodies and individuals highlighted ongoing unlawful health claims and implied therapeutic use.

Local authorities stressed the need for coordinated enforcement across Trading Standards, the Advertising Standards Authority and other regulators, noting that a mixed market of compliant and non‑compliant operators may continue to mislead consumers irrespective of authorisation.

Applicants and local authorities also raised concerns that consumers may confuse authorised and unauthorised products, particularly where unauthorised operators falsely imply compliance, or where authorised products appear less safe due to more explicit warnings. 

Analysis of responses indicates that there is a general understanding amongst consumers, industry and trade bodies that CBD is, and should be, recognised as a food supplement. 

Across responses, stakeholders were clear that accessible FSA guidance will be essential to ensure authorisation supports informed consumer decision-making rather than exacerbating existing misperceptions.

Vulnerable groups and under-18s

There was broad support across all stakeholders for the proposed protections for under 18s and vulnerable groups, with 65% of respondents agreeing that prominent warnings and marketing restrictions are necessary and proportionate.

Many industry respondents noted that responsible businesses already avoid marketing to children and operate age verification systems. 

Respondent: “We consider the proposed labelling requirements to be sufficient to mitigate against consumption by under 18s… a clear statement such as ‘Not suitable for persons under 18 years’ provides an appropriate and proportionate safeguard.”  

Respondent: “Yes… labelling is combined with retailer compliance checks… clear trading standards advice… products targeted to children should be removed or redesigned for an adult market only.”

Supportive respondents widely endorsed clear mandatory warnings, noting that consistent, prominent labelling, particularly when aligned across all product types, would help protect both under 18s and vulnerable groups. 

Some applicants advocated using QR codes or peel and read labels to accommodate warnings alongside other required information such as ADI messaging and portion sizes. 

Several responses from individuals and local authorities also highlighted the importance of accessible, inclusive labelling, including the use of symbols or simplified formats to ensure all consumers are being reached. 

However, responses from enforcement bodies and individuals also emphasised that labelling alone may not be sufficient.

Many noted that product formats such as gummies, confectionery and brightly coloured items may appeal to children regardless of warnings. 

Several responses across stakeholder groups and local authorities referenced parallels with youth uptake of vaping, arguing that warning labels alone have not prevented underage experimentation in similar sectors. 

Respondent: “Yes. Labelling is not an effective safeguard. Experience with vaping shows that warning labels do little to prevent under-16s from using products. The most vulnerable individuals are also the least likely to read or comply with labelling. Substances such as CBD, with medicinal uses but negligible nutritional benefit, should not rely on labelling for protection – they should be regulated as medicines.”

Responses from enforcement bodies also highlighted challenges with online marketplaces, where age verification is inconsistent, and stressed the need for strengthened compliance monitoring. 

Responses from trade associations felt stronger language or explicit symbols would be more effective than “not suitable for under 18s”.  

Overall, responses across stakeholder groups broadly supported the labelling approach.

However, many stressed that labelling must be accompanied by enforcement, clearer guidance for businesses, and actions to manage product formats that may be appealing to children to ensure consumer protection is effective across the whole CBD sector. 

Respondent: “Yes, although a monitoring mechanism could evaluate effectiveness.”

The legal status of CBD products and presence of controlled cannabinoids

Stakeholders provided extensive comments on the legal status of Tetrahydrocannabinol (THC) and how this interacts with enforcement responsibilities under both the Novel Foods Regulations and drugs legislation.

Local authorities including several trading standards teams and food enforcement officers, were particularly clear that the overlap between food law and the Misuse of Drugs framework creates significant challenges in practice.

They reported inconsistent enforcement approaches across regions, variations in how and when police involvement is sought, and uncertainty over who holds responsibility when a product breaches both food and drugs thresholds. 

Respondent: “Local Police have not been keen to get involved… this will become an area solely enforced by Food Authorities… robust tools for enforcement must be available.”  

Respondent: “Potential for THC enforcement to fall to different enforcement bodies… need commitment from Police to assist LAs… would welcome guidance.”

The above concerns were echoed by trade associations who warned that the dual regulation landscape risks creating enforcement gaps without clear, nationally agreed procedures. 

Across these groups there were consistent calls for coordinated guidance jointly developed by the FSA, the Home Office and local authorities to ensure consistency and reduce the likelihood of misinterpretation or unnecessary seizures.  

Some individual respondents argued that no THC should be present in food at all, expressing the view that any detectable THC should categorise a product as a medicinal product rather than a food.

In contrast, trade associations emphasised that THC and CBD fall under distinct regulatory regimes and should not be conflated. They noted that while this separation is important, it also contributes to the operational difficulties enforcement bodies experience when handling products that potentially breach both regimes.

These trade associations urged that responsibility pathways must be clearly defined so that officers know how to proceed when encountering products that exceed thresholds under either food or drugs legislation. 

Applicants and industry stakeholders also raised detailed concerns about laboratory testing and consistency warning that without robust, standardised analytical testing methods, products may fail compliance due to laboratory variability, particularly as THC values can shift over shelf life.

These concerns were echoed by the wider CBD industry who cautioned that inconsistent testing risks undermining consumer confidence and may contribute to disputed results or claims of failed drug tests.

Trade associations raised further concerns about gaps in sampling and testing capacity within local authorities, reinforcing the need for a coordinated, reliable national approach.  

Respondent: “Revised THC specification limits require standardised analytical testing methodology… without this, products may fail due to variability… essential the FSA establish a validated standardised method… proactive THC monitoring will safeguard consumer confidence.”

Another response raised concerns about the presence of other cannabinoids in CBD products, in addition to THC noting that when CBD is extracted from the plant, very small amounts of other cannabinoids can sometimes appear unintentionally.

The response highlighted that while the consultation focuses on THC, it is also important to be aware of these other substances so that products remain safe and compliant with drugs legislation. 

Suggestions were made to indicate that there is an opportunity to strengthen national testing approaches in future, which would help enforcement bodies check products more consistently and ensure that CBD food products stay within legal limits. 

Not all stakeholder contributions were critical. Some applicants and industry actors supported the FSA’s overall approach to THC control, noting that clearly defined limits offer regulatory certainty and help maintain consumer safety.

Respondents in this group suggested that, with appropriate testing capability, the proposed requirements should not impose undue burdens on compliant businesses.

Several local authority respondents also acknowledged the value of defined THC parameters, provided they are supported by national guidance that enables consistent decision-making. 

Applicants stressed that if accredited, reputable laboratories are used, THC compliance should be achievable; however, they also highlighted that inconsistency in testing practices can result in avoidable failures. 

Respondent: “As long as products are tested correctly, by reputable laboratories, then there should be no impact.”

Alongside these comments, the European Industrial Hemp Association (EIHA) submitted a detailed response challenging the proposed THC specification in the draft recommendation for their application (RP 427), arguing for higher limits (than 0.0001%), and calling for a harmonised THC threshold across all CBD isolates.

EIHA stated that such harmonisation would reduce industry confusion and improve consistency in manufacturing. Their position raises substantive questions that will require further internal consideration and are reviewed in the next section of the consultation. 

A substantial number of comments were made on the widely referenced 1 mg THC per container threshold, with industry stakeholders, applicants and some local authorities questioning the practicality and proportionality of a per container approach.

Several respondents argued that alternative models, such as those based on daily intake, would better reflect international practice and help avoid unnecessary product withdrawals.

However, these matters fall outside the scope of this consultation and outside the FSA’s regulatory remit. The 1 mg THC per container threshold is set under Home Office drugs legislation and is not an FSA proposal. As a result, the FSA cannot amend this requirement through the novel foods authorisation process. 

Further detail on the feedback received is set out in the out-of-scope section of this summary. 

Across all stakeholder groups, the responses highlighted persistent concerns regarding proportionality, practicality and the operational challenges created by the dual regulation of THC. 

There was a strong consensus on the need for co-ordinated guidance between the FSA, Home Office and local authorities, to support consistency in applying THC limits and to prevent misinterpretation of regulations that could result in unnecessary enforcement action.

Enforcement

We received 17 detailed responses about enforcement, with enforcement bodies raising significant concerns about their capacity to enforce the proposed terms of authorisation. 

These responses reported constrained resources, gaps in staff expertise and limited funding for sampling and laboratory analysis.

Several warned that without additional support, enforcement bodies may struggle to manage the increased workload associated with authorisations, particularly during the transition period when authorised and unauthorised products may coexist on the market. 

Respondent: “Expensive to sample. Need further training. Limited resources and limited expertise.”

A recurring theme was the absence of a national testing framework for CBD and THC. 

Responses from applicants argued that inconsistent laboratory methods undermine confidence in results, creating challenges in proving noncompliance, and risks uneven enforcement across the UK. 

The intersection between food law and drugs legislation was also frequently cited as a key challenge across stakeholder groups.  

Many responses across stakeholders emphasised that ambiguity about THC thresholds, controlled substances and enforcement responsibilities complicates consistent decision-making and may result in cautious or uneven enforcement. 

Across both enforcement and industry respondents, there was a strong call for clear, practical, and jointly issued guidance from the FSA and the Home Office to help authorities and businesses navigate these issues.  

Respondent: “Main enforcement challenge will be ensuring consistency… wide variation in how Trading Standards and Environmental Health  interpret food law and drugs legislation… FSA should issue clear, practical enforcement guidance… A single, unified  enforcement approach will help  maintain consumer confidence.”

Finally, many responses warned of the broader regulatory burden.

Enforcement bodies emphasised that authorisation may increase the complexity of their work, while businesses expressed concern that inconsistent or burdensome enforcement could undermine confidence in the regulatory regime. 

Across stakeholder responses the importance of proportionate, consistent, and well supported enforcement frameworks to ensure the success of CBD authorisation were stressed as being essential.  

Respondent: “Concern that non‑compliant products could remain on the market… need clear allocation of responsibility… clear guidance and flow chart for enforcement… maintaining consistency in the Public List will assist enforcement.”

The Public List

Stakeholders, including applicants and trade bodies, raised substantial concerns about how the Public List will operate after the first authorisations. 

Many feared a two-tier market, with isolate-based authorised products gaining an early competitive advantage due to data protection provisions, while the remaining applicants, including broad spectrum applicants, continue progressing through the system. 

Across the 38 responses to the consultation questions about the Public List, stakeholders consistently highlighted the risks of market distortion, market fairness, consumer understanding, and the transitional handling of products remaining on the Public List once authorisations begin. 

Uncertainty about the status of products remaining on the Public List was a major theme. Several applicants warned that retailers may prematurely delist products, misinterpret compliance, or remove products unnecessarily. 

Whilst other applicants emphasised that authorised products may appear less safe because they carry more extensive labelling requirements than Public List products, potentially confusing consumers. 

As a result, stakeholders across the board called for more consistent labelling across all products, regardless of authorisation status, to support transparency and reduce confusion. 

Respondent: “Authorisation will bring greater clarity and confidence… but will create a transitional challenge… transitional arrangements allowing continued sale of Public List products… guidance for retailers and enforcement.”

Consistent with these themes, many respondents from within the industry, trade bodies and enforcement bodies strongly emphasised the need for clear transitional arrangements.

Over a third (37%) called for defined provisions allowing products on the Public List to remain on the market during the transition, provided they meet equivalent safety standards.

Stakeholders also requested transparent communication directed at consumers, industry, and enforcement authorities on how to interpret the Public List during and after the authorisation of the first CBD products.  

Respondent: “Clear guidance on transition periods is essential… products already on the public list should not be unfairly disadvantaged… businesses that have invested in compliance should be supported.”

Advertising was another area of concern. Applicant responses hoped that product authorisation might lead to a relaxation of existing online advertising restrictions for CBD products.

However, others feared that such changes would benefit only the authorised products, widening the competitive gap between authorised and Public List products even further. This reinforced wider concerns about the creation of an uneven playing field during the implementation phase.  

Overall, consultation responses showed that there are widespread concerns particularly from applicants for the potential market impacts of authorisations on the status of existing products on the Public List.

There was an emphasis that discontinuing the Public List or changing the way it operates could undermine fairness and confidence in the regulatory regime. 

To address these risks, respondents stressed that the Public List must continue to be used post authorisation, supported by clear guidance, consistent labelling, and well managed transitional steps.

This would help ensure that retailers, enforcement bodies, and consumers can navigate the evolving market without confusion whilst maintaining trust, market stability, and clarity during the shift from the Public List to the Novel Foods Register. 

Respondent: “Public relies on the Public List to assess legality… confusion will arise… educate consumers that the list is temporary… approved dossiers should be clearly communicated.”

The FSA recognises that further consideration will be needed on how the Public List operates once the first authorisations come into force. Although the operation of the Public List is not directly covered by this consultation, these issues have been acknowledged.

The FSA expects to consider, in due course, how the Public List should operate alongside authorised products, to support clarity for consumers, retailers, enforcement bodies and industry, and to maintain confidence in the regulatory framework. 

The Advertising Standards Authority (ASA) is the UK’s independent regulator of advertising. Its main role is to make sure advertisements across all media are legal, decent, honest and truthful, and to protect consumers from advertising that is misleading, harmful, offensive or irresponsible.

The ASA investigates complaints from the public and businesses, monitors advertising proactively, and can require advertisers to amend or withdraw advertisements that breach the advertising rules. The advertising rules themselves are written by the Committees of Advertising Practice (CAP).

Data protection

Data protection provisions generated mixed views, with the majority of responses coming from other applicants still progressing through the authorisation system.

Many expressed concern that a five-year exclusivity period for the first three authorisations could create an uneven playing field, particularly for applicants with similar products who may be unable to reference proprietary toxicology data.

Respondents worried that this could result in a temporary monopoly based on sequencing rather than scientific merit and raised questions about the transparency of how data protection is applied in decision-making. 

Respondent: “Five years of exclusive data protection… would effectively restrict market access… majority of CBD products on the Public List could not legally remain… risks distorting competition… essential to maintain fairness and consumer access.”

Applicants stressed the need for clarity on how data protection will be implemented, urging the FSA to confirm that exclusivity should not prevent authorisation of products that can demonstrate equivalence, even if supported by parallel or non-proprietary datasets. 

There were suggestions that publicly available toxicological evidence, or non-proprietary components of dossiers, should remain accessible for reference.

Some applicants proposed an alternative approach of transitional or generic authorisation models to avoid penalising products on the public list that have yet to complete the assessment process. 

Respondent: “Overly restrictive provisions have already created monopolies… mechanisms for shared access to toxicology data under reasonable terms would support effective enforcement and a healthy marketplace.”

Enforcement implications of data protection provisions were also identified.

Local authorities highlighted practical difficulties distinguishing between ingredients associated with authorised products and those belonging to products still undergoing assessment, warning that inconsistent access to underlying evidence may result in enforcement gaps or inconsistent practice.  

Other responses from trade bodies and applicants strongly supported the data protection measures, arguing that exclusivity is necessary to reward investment in high-quality safety data and protect the integrity of the novel foods system. 

They argued that diluting exclusivity provisions risks weakening the integrity of the novel foods process by allowing competitors to ’piggyback’ on costly, privately generated evidence.

These respondents urged the FSA to maintain robust data protection measures to uphold incentives for safety research and maintain confidence in the regulatory regime. 

Respondent: “It would be inequitable and damaging if proprietary data… were made public or used to support competing applications… Allowing competitors to ‘piggyback’ on protected data would distort the market… undermine innovation…”

Respondent: “Data protection… could create an unfair advantage for the first authorised applicants… [but] this is consistent with the treatment of other authorised novel food ingredients… allows existing products to transition to compliance…”

Across all responses, the prevailing themes were the need for clarity, fairness, proportionality and transparency. While views differed on the merits of exclusivity, there was a broad consensus that clear guidance as authorisations progress is needed.

Responses outside the scope

Across the consultation as a whole, a total of 63 comments were categorised as out of scope.

These comments were raised across responses to all 14 consultation questions and did not relate directly to the questions asked or to the proposed authorisation terms.

While they often reflected wider views on CBD, cannabis policy or the operation of the novel foods system, they fell outside the scope of this consultation. As a result, no actions are proposed to address them in this consultation. 

Where comments received relate to matters outside of the FSA’s remit, the FSA has informed the relevant Government department who would be responsible for taking any action.

The key themes raised that were deemed to be out of scope of this consultation are summarised below.

ADI

A number of respondents provided comments on the FSA’s consumer advice in relation to the current ADI for CBD.

These included calls for the ADI to be reviewed periodically as new evidence emerges, reconsideration of the current level and suggestions that higher intake levels may be appropriate.

These comments relate to the FSA’s consumer advice on CBD consumption rather than the proposals within this consultation which focused on the proposed labelling requirements and maximum permitted level as conditions of authorisation, which were informed by the existing ADI.

Therefore, comments regarding review of the ADI itself have been considered outside the scope of this consultation. 

As with any risk assessment, we would consider updating our advice should relevant new evidence become available. Any future review would likely be driven by the availability and significance of new evidence, and the potential for it to affect the existing risk assessment.

THC and drugs legislation

A substantial number of out-of-scope comments were made on the widely referenced 1 mg THC per container threshold.

Industry stakeholders, applicants and several local authorities described this approach as impractical, disproportionate and misaligned with international norms.  

Responses across the CBD sector highlighted potential impacts on businesses, particularly those working with bulk ingredients, and raised concerns about the UK becoming an international outlier. 

Several respondents suggested that THC controls based on daily intake would better reflect approaches used in the EU and US and could help reduce avoidable removals of products.

Others emphasised the importance of international harmonisation to avoid distorting trade. 

While these views are noted, responsibility for drugs legislation, including exempt product definitions and THC thresholds, sits with the Home Office rather than the FSA. Where appropriate, these views have been shared with the relevant department.

Novel foods process, fairness and resourcing

A substantial number of out-of-scope comments focused on the fairness and functioning of the novel foods process.

Respondents raised concerns about delays, administrative sequencing and overall system fairness.

Some pointed to ongoing scrutiny of the CBD novel food process and argued that the current approach risks creating a system perceived as slow, inconsistent or lacking transparency. 

Several respondents also argued that CBD authorisations may be diverting regulatory resources away from other novel food applications, potentially delaying innovation in areas with clearer nutritional or environmental benefits.

Calls were made for broader reform of the novel foods framework, including clearer prioritisation criteria, improved transparency on costs, and consistency in how applications are progressed.

Market distortion and systemic fairness

Some respondents claimed that the FSA’s approach to CBD authorisations could distort the market or ‘create a cartel-like environment’ if sequencing advantages remain unaddressed.

This theme frequently echoed concerns expressed elsewhere in the consultation (for example, data protection), but here was raised in a generalised or speculative form not tied to the consultation questions.

Concerns also included claims that the 10 mg/day ADI could act as a future barrier to market entry and limit product innovation across the sector.

Cannabis legalisation, criminalisation and drug policy

A recurring theme across out-of-scope responses related to wider drug policy, not the specific proposals under consultation.

These included: - calls to criminalise CBD products entirely - calls to legalise cannabis - remove restrictions on CBD - regulate CBD under a different policy framework - views about the societal benefits or harms of cannabis products generally

These comments reflected broader political views and did not relate to the specific authorisation terms which were subject to consultation.

Regulation as medicines rather than foods

A number of respondents argued that CBD should be regulated as a medicine rather than as a food or food supplement - either because of its association with therapeutic use, psychoactive components of the cannabis plant, or the belief that existing medical regulatory frameworks would offer clearer safeguards.

Others suggested that whole plant hemp extracts should be exempt from novel foods controls. These views fell outside the scope of this consultation, which specifically concerns CBD novel foods applications.  

CBD in the context of these applications does not meet the definition of a medicine and is being considered under the novel foods framework. As such, these comments fall outside the remit of the FSA.

The FSA will, however, clarify this position in guidance to reduce the risk of consumer misunderstanding.

Wider views on CBD regulation

Some out-of-scope comments reflected general advocacy positions, including both antiregulation sentiments and industry-led calls for deregulation or market liberalisation.

These did not address any question within the consultation itself and were therefore not considered within scope.