Food Standards Agency tightens regulation of CBD food products

20 April 2022

In a bid to better regulate the public sale of legal cannabidiol (CBD) ingestible products, the Food Standards Agency (FSA) has published a list of CBD food products that have been given the green light to remain on sale to the general public in England and Wales, at least for the time being.

This is a significant development and places the UK as the first country in the world to regulate these products. In this blog, we take stock of this evolving regulatory landscape, the key events that have shaped and continue to shape it, and what this means for companies and individuals already in the industry, those considering entering it, and those considering investing in it.

A potted history

Legal CBD food products have been available to buy in shops and online within the UK for some time. Regulatory controls for novel foods, such as those containing CBD, were first considered in May 1997 with the adoption of EU Regulation 258/97, from which date novel foods were subjected to a risk assessment prior to their sale and use. Novel foods are therefore foods which have not been widely consumed by people in the UK or EU before May 1997. These regulations have undergone subsequent revisions and were repealed and replaced by EU Regulation 2015/2283.

However, with the UK’s exit from the EU in 2020, the UK adopted new regulations (The Novel Food (Amendment) (EU Exit) Regulations 2019) which gave regulatory remit over novel foods to the FSA. Then, on 13 February 2020, the FSA announced:

From the date of our announcement (13 February 2020), no new CBD extracts, isolates or associated final products using this novel ingredient, including new brands, should be put on the market until they have the necessary authorisation. A validated application is not sufficient to put new products on the market. We expect all other CBD products not on the list to be voluntarily withdrawn. Local authorities are responsible for enforcement and may remove these products from the market.

Suppliers of CBD products on sale in England and Wales on or before 13 February 2020 were therefore required to submit an application for assessment by the FSA, by 31 March 2021 (which was thereafter subject to revision). CBD products that entered the market after 13 February 2020, or that failed to submit an application before the deadline of 31 March 2021, were to be removed from sale until such time they are authorised by the FSA. Notably, this applies only to CBD food products; non-ingestible CBD products such as inhaled CBD products, cosmetics and massage oils do not fall within the FSA’s remit.

Publication of a new list of CBD food products

The FSA received around 900 applications before the deadline. A third of these were rejected, and some were withdrawn. The outcome of this process has resulted in the publication of a new list of just over 3,500 CBD food products that have either been ‘validated’, meaning their applications contain all information required by law to proceed through the authorisation process, or their application is progressing towards validation, but the necessary information is yet to be provided.

Importantly, validation does not mean the product has been authorised. Rather, it means the product’s application to the FSA contains all the information needed, including the necessary evidence to carry out a risk assessment, for it to proceed to the authorisation process.

Being on the list is therefore not a guarantee that authorisation will be granted. It does however mean that those products can legally remain on the shelves, thereby providing some temporary certainty for producers, suppliers, investors, and consumers. All CBD ingestible products that are not on this list must now be removed from sale.

What this means for the CBD food product industry

The FSA’s move to more tightly regulate the CBD food product market in England and Wales has meant that a significant number of products previously available to buy online and in shops, but which have not made the published list, must now be removed from sale.

For producers of CBD products that have not made the list, the immediate prohibition of their products is understandably unwelcome news. While there is no appeal process for these decisions, they will have been based on the FSA’s assessment that insufficient information has been provided for a proper risk assessment to take place. In that event, there is an option to re-submit applications to the FSA with a revised dossier containing additional information needed to pass the initial validation stage.

The FSA is advising suppliers of products that have not made the list to voluntarily remove them from sale. Decisions on enforcement for non-compliance rests with local authorities and the FSA has advised authorities to determine their enforcement priorities bearing in mind the fact that suppliers are moving towards compliance. However, if voluntary removal does not happen, enforcement action by local authorities is likely.

Manufacturers and suppliers of products on the list may continue to produce and sell their products to the public while the FSA undertakes a full assessment as part of the authorisation process. The FSA makes clear it cannot endorse the safety of such products until such time that it has completed its assessment. Nor is there any guarantee that following their assessment, they will be authorised. Consumers are therefore advised to refer to the list of products, but to exercise their judgement bearing in mind that their safety has not yet been assessed.

While the FSA’s actions may at first glance be considered to stifle the market, greater regulatory certainty and clearer guidelines may in fact inspire further innovation in this space by increasing levels of consumer and investor trust in the products they are buying or consuming, or investing in. The difficulty for manufacturers and suppliers is knowing what kind of toxicology testing is needed to gain authorisation and the lack of clarity and policy guidance by the FSA to marshal applicants through the process. There are currently no standards against which CBD products should be tested, including the sensitivity at which such testing needs to be conducted. Nor is there a list of accredited laboratories to assure manufacturers that their products are being tested using appropriate techniques. While the FSA’s intention to regulate CBD products may be justified, it can only work within the current framework available to it, which unfortunately is lacking. Ultimately, this means that manufacturers and suppliers of these products are left navigating incredibly uncertain terrain. Despite a product being on the new list, if Home Office standards later impose requirements on those products to fall within certain CBD levels, to be tested in a certain way, or by a laboratory which the FSA decides is accredited, and those products do not meet these new standards, this may very well affect authorisation being granted, meaning additional costs and time will have to be re-invested into the product.

For consumers, although the list does not offer any endorsement regarding the safety of the products on it, it does start to offer greater guidance to consumers enabling them to make more informed choices about the products they buy. However, for all involved in the CBD food products industry, the journey towards achieving the clarity and certainty that is needed for the industry to reach its full potential is very much in the initial stages. Worryingly, what appears to be happening is the inverse of how regulation should operate; rather than the FSA’s authorisation process being underpinned by a clear standards framework, there is a real danger that authorisation of CBD food products may either be granted before safety standards have been agreed, or stalled at the very last leg of the process because they do not meet the new standards when they are set. 

FURTHER INFORMATION

If you have been affected by the developments reported in this article, or would like more information or advice, please contact Shannett Thompson.

 

ABOUT THE AUTHORs

Shannett Thompson is a Partner in the Regulatory Team having trained in the NHS and commenced her career exclusively defending doctors. She provides regulatory advice predominantly in the health and social care and education sectors. Shannett has vast experience advising  regulated individuals, businesses such as clinics and care homes and students in respect of disciplinary investigations. She is a member of the private prosecutions team providing advice to individuals, business and charities in respect of prosecutions were traditional agencies are unwilling or unable to act. In addition Shannett has built up a significant niche in advising investors and businesses in the cannabis sector.

Lucinda Soon is a professional support lawyer in the Regulatory team, and is responsible for knowledge management and practice development. She has previously advised individuals and organisations in the legal and accountancy sectors on authorisations, compliance, ethics, and regulatory policy.

 

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