Novel Foods regulation review offers options for system overhaul
The FSA (Food Standards Agency), The UK's authority for novel foods, contracted Deloitte LLP to conduct a review of its Novel Foods assessment system at the end of 2022 (despite concerns over the firm’s links to the medical cannabis market).
An executive summary of the project was published on 7th June and in this article, Mark Tallon, managing director of consultancy firm Legal Foods, discusses its main findings and implications for the future of the UK novel foods market.
"The need for such a report was on the back of the overwhelming number of cannabidiol (CBD) submissions to the FSA post Brexit, bringing any timely assessment of novel foods to a grinding holt," Tallon explains.
He points out the text of the report highlights 'enabling innovation is a UK government priority' and 'a complex political landscape and continued pressure on resources within the FSA'.
"The FSA may have no choice but to consider the move to an alternate model or the industry will continue to be frustrated by the FSA missing its legal obligations to issue a novel food opinion within nine months of validation of an application.
"In addition, the pace of new technologies and the many novel foods already on the market but not enforced, points to a broken system."
The report looked to carry out “extensive external engagement" with Food Business Operators (FBOs); interest groups; food regulators in other jurisdictions and UK regulators.
Tallon argues this may not have been the case, saying: "We don’t believe many of the true stokeholds where fully engaged in the process as suggested within the report when it speaks of, 'any future proposals for reform would be subject to public consultation and give full consideration to the interests of consumers, as well as those of other stakeholders including Ministers, Parliament and the devolved administrations'.”
The review finds key issues with the current system, including:
- The outcomes of risk assessment and evidence requirements are not always clear to applicants, and opportunities for synergy through grouping applications for similar products and/or drawing on evidence and conclusions in other jurisdictions are not fully maximised.
- The risk management process does not allow for sufficient weighting of the potential benefits to wider society.
- FBOs would prefer guidance to be updated more frequently and dynamically, with advance guidance on emerging product classes. There is a great demand for more information and engagement across all stages of the authorisation process.
- There is limited capacity to build resources in anticipation of future demand. The complexity of administering a new system in a devolved UK context has been a drain on resources in the first years of operation.
- There are inefficiencies in the current framework in the form of: poor quality applications that may be ultimately rejected or require multiple rounds of processing; additional administrative effort around ministerial sign offs and statutory instruments for approved novel foods.
The five alternative models for the assessment of novel foods are listed below.
MODEL 1: No regrets opportunities
In this model the FSA could remove some of the main pain points from the existing process for the FSA, FBOs and consumers. Added features would be centred around improving accessibility, transparency and information around the framework, and removed features would be the additional process steps such as statutory instruments for novel foods which do not have a clear value-add.
Responding to this option, Tallon questions: "What will be stripped other than processes outlined in legislation? Could such removal result in less protection for business who want legal deadlines to ensure the FSA meet its obligations of a timely assessment?
"Additional features are considered as possibilities including accessibility, transparency, and information over the novel food framework but how will these be achieved?"
MODEL 2: Triaging
This model would change how the pipeline of novel foods applications is processed. This could include triaging and grouping similar applications into high/medium/low risk cases and tailoring the framework to provide a clear route for different emerging technologies. It could also include prioritisation of applications based on specific criteria.
The concern here, Tallon argues, is a possible push towards cohort assessments where IP must be shared. He argues there could also be a situation that grouped applications are fast-tracked vs. a small business being placed at the back of the assessment queue.
MODEL 3: Lifecycle based
The FSA could shift from a single point of authorisation of novel foods to a staged approach to regulation, incorporating a change in how safety of novel foods is established. The model incorporates a range of ways in which this could be achieved, such as conditional authorisation and ongoing monitoring. The model takes account of the fact that definitive evidence of the safety of certain products is not always available at the point of authorisation.
"This so-called lifecycle based approach takes its lead from what we have seen in the UK regarding CBD - tolerated until approved," explains Tallon.
"It may also lean on the current additives assessments where approval was granted based on available data, but a re-evaluation of safety is required.
"In this approach any adverse effects are monitored such as with the yellow card medicines scheme in the UK. At present post market monitoring of novel foods is by case by case (Article 24)."
MODEL 4: Global collaboration
The FSA could authorise novel foods using knowledge and insight from other organisations, constituting a shift in how the safety of novel foods is established. This could include recognising the evidence base or decisions of food regulators in other jurisdictions, and/or placing more responsibility on industry to assure safety. The model takes account of the fact that food innovation is global and rapid, and a shared global understanding of novel food safety may hence be appropriate.
Tallon suggests this model may of all be the most likely and could use insights from other organisations to approve novel foods e.g., Health Canada and/or the FDA in the US.
He asks: "The question is what would be accepted as assuring safety? Would it need to be a GRAS notification, or would a GRAS Self-Affirmation submission suffice? What about Canada would a view from Health Canada be enough or would it need to be from the Canadian Science Advisory Committee?"
MODEL 5: Innovation-centric regulation
The FSA could introduce one authorisation ‘front door’ for all products deemed high-risk enough to require authorisation, removing the Novel Foods Regulatory Framework in its current form and focusing more on consumer awareness of novel food safety. The model recognises that given the pace of innovation the current framework may not be fit for purpose and may need to be more anticipatory, adaptable and innovation-focused.
Tallon says it is unclear what this model may mean but it could be a complete move from current approach to novel foods to a ‘direct-to-consumer’ information model.
"Again, it is not clear what level of ‘risk’ an ingredient would need to present to exclude the possibility of an information campaign. Also, how would such information be delivered to the consumer? Perhaps an app or a website similar to novel foods catalogue could hold such data. Will there be an obligation for industry to communicate such information at the point of purchase on on-pack? We know smocking is dangerous but permitted with label warnings, would that work for foods?"
A sixth option?
The report states that the models are not mutually exclusive and the FSA could consider combining regulatory elements from each model when reviewing the existing Novel Food Regulatory Framework.
Tallon comments: "Under The General Food Regulations 2004 a food shall not be injurious to health and thus there is a general prohibition already placed on business. What is missing is an ability for consumer collective redress mechanisms that could be brought about in a similar manner to US style class action.
"In addition, we don’t have a direct personal injury claim that is defined in food law that results from a novel ingredient. Of course, we have the product liability directive, but this is much more difficult compared to making some sector specific enforcement rules including perhaps penalties that a based on strict liability. Such rules could ensure that business gets in place adequate science to protect itself and indeed to be able to be insured as food business.
"At present the novel foods regime is not fit for purpose with fixed monetary penalties of £200 (reduced to £100 if paid within 28 days of notice) of no incentive for business to comply."
Who are the enablers?
The summary talks about ‘Enablers’, or changes that will need to occur within the FSA (and its stakeholders) to ensure successful reform.
"If the FSA move away from a precautionary model to a reasonable certainty of no harm (US model) then if harm occurs will the FSA and its leadership be in the media firing line?" asks Tallon, "The report suggests a cultural shift will be needed to align to the change in risk. In addition to FSA management and staff the organisation will need to consider if it has enough expertise to put in place the proposed models and if it can adopt a way or working with stakeholders."
Conclusions
Tallon points out the published summary is only a snapshot of a larger report but what it does not include is a legal or regulatory analysis. But he says there are a few interesting comments within the summary.
"There are discussions in relation to Innovation-centric type model which may provide a registry of approved products perhaps in a similar manner to that of the CBD register. This site may also include in the case of supervised approvals, additional information for consumers on level of risk. What will such a register mean to the public and will they really be able to understand it?
"A very simple approach may be needed such as a colour coding system or similar so the average consumer can easily recognise a low, medium or high-risk food. Given the headache traffic light labelling has resulting in for nutrient profiling then we need to take some lessons before proposing a new one.
"Finally, there is discussion of transparency issues such as the publication of regulatory assessments (with removal of commercially sensitive info) but this is already in place in the most part but may now consider addition requirements that are implemented at EU level under Regulation (EU) 2019/1381.
"It is my view that the repeal and re-imagining of the UK novel foods system (just like the health claims system) needs a total overhaul. The market has already spoken and vast numbers of novel foods remain on the market due to either lack of understanding or simply giving consumers what they demand.
"Increasing the financial burden and complexity of novel foods submissions are not an effective way to support business but I do agree a balance between consumer safety, innovation, and freedom for business needs to be considered.
"The key will be to ensure the right stakeholders are involved in any future changes and the FSA does not get captured by trade associations or big pharma that wish to block the entry of new products onto the market."
