A novel approach to the regulation of CBD products – the Food Standards Agency’s ‘novel foods’ authorisation process explained

Posted: 16/06/2021

In 2020, the global cannabidiol (CBD) market was estimated at $2.8 billion and is expected to reach $7.5 billion by 2025 [1]. Within Europe, growth of 400% is anticipated with the market reaching $23.6 million by 2025 [2]. Based on CBD’s relatively recent classification as a ‘novel food’ [3], this article focuses on the regulatory framework set in place to govern its sales as a food supplement.

Manufacture and sales of CBD in England and Wales

CBD products are considered legal to manufacture in England and Wales (ie they are not regarded as illegal drugs) as long as they do not contain more than one milligram of Tetrahydrocannabinol (THC) [4] per container of product.

In relation to sales of CBD food products in England, responsibility for monitoring and enforcement rests with the Food Standards Agency (FSA) [5], based upon the classification of CBD as a ‘novel food’ [6]. Novel foods are foods and/or ingredients that were not consumed to a significant degree by humans in the UK or EU before 15 May 1997 [7].

The FSA’s new ‘novel foods’ authorisation process and interim acceptance of existing products pending full assessment

In February 2020 (and refined further in March 2021), the FSA confirmed the basis on which CBD products already on the market in England and Wales would be permitted to remain there, pending full scientific assessment by the FSA and receipt of full authorisation from a novel foods’ perspective.

Eligibility to avail of the ‘existing product on the market’ exception required proof of marketing (arguably anywhere on the EU market) prior to 13 February 2013 and receipt by the FSA of an application (prior to 31 March 2021), which is subsequently validated.

In this way it was, until 31 March 2021, possible to obtain a shortcut to novel foods authorisation and for a CBD-related product to remain on the market until the granting of such authorisation.

What exactly constitutes a ‘novel food’? The CBD component alone or the CBD component as used in or combined with a food product?

As the deadline to avail of the ‘existing product’ interim exemption drew near, it was unclear whether the entire finished product (food + CBD) or solely the CBD component contained therein ought to be regarded as the ‘novel food’ product marketed prior to 13 February 2020.

If the entire product was the relevant novel food, then a food product such as a gummy bear snack not sold prior to 13 February 2020 would not be permitted use of the fast-track and would need to await full authorisation before being sold on the market. This was even if it contained a CBD component which had been used on the market prior to 13 February 2020 and after that date.

Conversely, if the focus for novel food status lay on the CBD component alone, evidence of that CBD component being contained within any other products sold before 13 February 2020 would allow the new food product containing that CBD component to be sold on the market pending full assessment and authorisation (following the validation checks alone).

In response to this uncertainty, the latest guidance from the FSA was that it would be the entire product, rather than any CBD component, that would constitute the novel food. The deadline of 31 March 2021 to avail of the exemption has since passed and anyone unhappy about or prejudiced by the FSA’s interpretation would have to challenge it in court.

In any event, the deadline placed on the fast-track route has now passed, so any CBD products manufacturer that missed it will need to obtain full authorisation before being able to sell or continue to sell to consumers. Detailed guidance and application requirements are set out in retained EU law [8] [9].

When might novel food authorisations be issued by the FSA?

In terms of timeframes, it can take several weeks for a validation to be received following submission of a novel foods application, subsequent to which applications proceed to the risk assessment phase. That latter stage can take up to nine months, with a further seven months [10] for any subsequent risk management considerations and authorisation.

Any authorisation obtained for a CBD product applies to that product only. FSA guidance confirms that this means ‘using the same detailed production methods, for the exact same uses as described within the authentication and using the same safety evidence base’. [11]

Other regulatory considerations?

Even assuming success with the authorisation process, that is not the end of the regulatory jigsaw. Placing a CBD product on the market in the UK also requires compliance with a plethora of further obligations, including import/sale, safety, nutritional content, allergies, packaging and labelling, advertising, premises and traceability/recalls. More to follow on these further obligations in future articles.

It will be very interesting to see which of the existing novel food products on the market are authorised by the FSA following assessment, as it is widely suspected that too many CBD products currently out there have varying levels of THC rendering them potentially hazardous.

This article has been co-written with Carys Ley, a trainee solicitor in the commercial dispute resolution team. 

[1] https://www.grandviewresearch.com/industry-analysis/cannabidiol-cbd-market. Cannabidiol Market Size, Share & Trends Analysis Report By Source Type (Hemp, Marijuana), By Distribution Channel (B2B, B2C), By End-use (Medical, Personal Use), By Region, And Segment Forecasts, 2021 - 2028. Cannabidiol Market Growth Analysis Report 2021-2028, Grand View Research
[2] https://www.prnewswire.com/news-releases/europes-cbd-market-projected-to-grow-by-400-301117489.html. Europe's CBD Market Projected To Grow By 400% - Financialnewsmedia.com News Commentary, Aug 25 2020.
[3] The EU Food Safety Authority lists those foods and ingredients classified as ‘novel’ within the ‘EU Novel Food Catalogue’. Whilst the catalogue has no legal standing, its guidance may be accorded substantial weight by national competent authorities such as the FSA.
[4] THC is defined as a ‘controlled substance’ under Regulation 2, Misuse of Drugs Act 1971.
[5] As provided for by Article 3 of the Novel Foods (England) Regulations 2018 (SI 2018/154) (in line with EU Regulation 2015/2283). These regulations remain in force notwithstanding the repeal of the European Communities Act 1972 under Brexit (European Union (Withdrawal Agreement) Act 2020).
[6] The FSA is the competent authority for England, Wales and Northern Ireland, having been established in 2000 by the Food Standards Act 2000.
[7] Regulation (EU) 2015/2283 – see also the Novel Foods (England) Regulations 2018 (as amended by the Novel Food (Amendment) (EU Exit) Regulations 2019/702).
[8] For instance, the procedure for authorising the placing of a novel food on the market within England and Wales is set out in Article 10 (EU Regulation 2015/2283) (as amended by Article 16 of Novel Food (Amendment) (EU Exit) Regs 2019)).
[9] Please note that local advice within the jurisdictions of Scotland and Northern Ireland would need to be obtained as the processes involved in relation to novel foods differs across the UK.
[10] This may be longer if the FSA is required to give an ‘opinion’ first, and – whilst it may be providing an overly cautious estimate – recent correspondence with the FSA indicates this could take as long as 15 months.
[11] https://www.food.gov.uk/news-alerts/news/food-standards-agency-sets-deadline-for-the-cbd-industry-and-provides-safety-advice-to-consumers

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