Guest Post

Embracing the ‘Art of the Possible’ in Novel Food Regulation

By David Hardstaff and John Binns

- Last updated on GMT

getty | law diccar
getty | law diccar

Related tags Novel foods FSA

In this guest article, David Hardstaff and John Binns, Partners at BCL Solicitors, discuss a high-profile investigation into banned muscle-building drugs which highlights issues with the novel foods regime impacting the CBD industry.

A recent BBC investigation​ into banned muscle-building drugs, selective androgen receptor modulators (Sarms), highlights the need for a clearer and more dynamic novel foods regime.

It seems help might be at hand in the form of a report commissioned by the Food Standards Agency (FSA), which proposes, amongst other models, the complete dismantling of the current system​. The challenges are great as the lines between food, medicine, and technology become increasingly blurred. Is the FSA really up to demonstrating the “art of the possible” in terms of how the Novel Foods Regulatory Framework could be improved?

The FSA has categorised Sarms as unauthorised novel foods amidst concerns that the drugs can cause a wide range of adverse side effects. Favoured by bodybuilders and weightlifters, Sarms are claimed to mimic the effects of anabolic steroids, potentially increasing muscle mass and strength. However, despite restrictions on their sale, they have been openly sold online, in shops, and in gyms throughout the UK.

The BBC’s investigation highlights both a lack of understanding on the part of potential consumers, and evidence that suppliers of Sarms are misleading users, whether intentionally or through ignorance, as to their risks.

At first glance, the treatment of Sarms as unauthorised novel foods will sound familiar to anyone with more than a passing interest in the UK’s previously burgeoning cannabidiol (CBD) industry. The trade in consumer CBD products – marketed mostly as food supplements – ballooned in the three-year period leading up to the FSA’s effective ban on new products.

In the UK, CBD products were also able to ride the wave caused by the 2018 change in legislation that allowed for easier access to medicinal cannabis products; that development lent a degree of credibility to many products that, whilst careful not to make any claims of medicinal efficacy, flew under the banner of products intended to promote ‘wellness’.

Like Sarms, CBD products have quickly developed a loyal following. However, in contrast with Sarms, their potentially wide application means they have appealed to a more diverse range of consumers with a broader range of needs. And, although research is ongoing, there appears to be significantly less evidence of moderate CBD use leading to harmful side-effects compared with Sarms, which has been linked with erectile dysfunction, mood swings, and liver problems.

The origins of both products are also worth considering. CBD is a naturally occurring cannabinoid, one of around 140 found within the cannabis plant. To suggest that there is no history of its consumption before 15 May 1997 – broadly speaking, the starting point when defining a novel food – has been criticised by many as disingenuous. Like it or not, cannabis has been consumed from the moment humans discovered it. It has been consumed for all manner of reasons, including for recreational purposes, but also for its nutritional and therapeutic properties, inevitably in part thanks to its CBD content.

Sarms, on the other hand, were created by accident in the 20th​ century. An unintended byproduct of research into prostate cancer treatment, they have since been developed to combat muscle-wasting disease. Notwithstanding their potential for the treatment of certain conditions, they also come with a wide range of adverse side effects, justifying their tighter control.

Despite their differences, Sarms and CBD products fell to be regulated by the FSA under the same framework. Arguably, the most striking common feature of these two examples is neither their ‘novelty’ nor their safety for consumers, but the lack of clarity and transparency in their regulatory status. Many would say the root of this is the UK’s novel foods regime itself, which was carried over from the EU system following the Brexit implementation period. Calls for change have, it seems, been heard by the FSA itself.

In October 2022, the FSA issued an invitation to tender for a review of the Novel Foods Regulatory Framework, the process by which new foods are brought onto the UK market. Deloitte was selected and has published its key findings in the form of an executive summary, which proposes a range of alternative regulatory models on which the FSA could base a revamped UK-specific Novel Foods Regulatory Framework. The problems with the current system are considered and will come as a surprise to few with experience of the current system, including inefficiency, and a lack of guidance and transparency.

The features of the models considered better reflect the wide range of products which could be caught by novel food regulations, including. They five options suggested (detailed in a previous NI article​) cover everything from simply removing the main 'pain points’ from the existing process, to removing the Novel Foods Regulatory Framework in its current form to focus more on consumer awareness of novel food safety.

The report doesn’t shy away from the need for sweeping reform. In fact, it aims to “demonstrate the art of the possible”, which presumably means doing away with much of the current regime and starting again. The flexibility and opportunities that come with this approach would presumably allow for a more nuanced approach, accounting for the increasingly wide and complex range of products coming under its jurisdiction.

Taking the same regulatory approach in respect of both CBD products and Sarms arguably doesn’t add up. Both categories of product technically fall within the existing definition of a novel food, but that’s about where the similarities end. Applying such a blunt approach only alienates business and consumers, who could otherwise be brought along for the journey towards potential authorisation.

The executive summary is just that: It’s fairly high-level stuff and could arguably be criticised for proposing such a wide range of alternatives (anything and everything), that it doesn’t take the discussion much further forward. However, embracing the proposition that starting from scratch might be the best approach is to the FSA’s credit, and about as progressive a starting position as can be expected in the usually cautious world of regulation.


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