Novel food regulation within the cannabinoid industry has certainly caused some uproar. In February 2020, the Food Standards Agency announced that all ingestible CBD products, be that CBD oils, CBD drinks, or CBD chocolate, must secure Novel Food Status by 31st March 2021. If brands failed to do so, they were warned their range would be pulled from the market.
This naturally led to widespread panic in the industry. Individuals who had poured their life and soul into making their CBD business dreams a reality were hit with the task of completing extensive, complicated paperwork and paying thousands in fees. One company, Pureis (who became one of only 3 brands to be given authorisation by the initial deadline), claim to have paid in excess of £1.5m to ‘complete a full suite of clinical studies necessary to meet the FSA and the European Food Safety Authority (EFSA) evidence’ over the course of 18 months.
Unsurprisingly, some brands folded right away. However, many others in the multi-million pound industry clung on and fought to get their applications in, only to be met with disappointment. On April 19th 2021, three brand names (Pureis, CBDex and 4MP) made the very sparse list. Everyone else was left in a state of flux, until recently, on the 22nd of February 2022, the list was finally updated again to include a more comprehensive list of over 3,500 CBD food products (which includes oils) on sale in England and Wales which have a credible application for authorisation with the FSA. This was then updated again to reach a still relatively low number of 5,900 products. These can be found in the Novel Food Catalogue. Another update is expected later in the year.
The FSA have advised that products not on the list should be removed from sale. These aren’t just ‘the little guys’ either, as they include a David Beckham-backed range of ingestibles and other well-known brands such as Vita Coco (previously sold in Sainsbury’s) and CBDfx (sold in Boots).
A novel food is any food/food ingredient that has not been eaten to a significant degree by people within the EU or the UK prior to 15 May 1997.
Although some people argue that the cannabis plant has been ingested by humans for many thousands of years, the isolated CBD molecule, and CBD oil, is a new thing. It could be argued that whole plant cannabis oils should not fall into this, but the FSA would strongly disagree.
Making an application to have your product authorized as a Novel Food is free, but the process to obtain full authorisation can be lengthy and expensive. It is, however, now essential for selling CBD oil legally.
Although CBD oils are available on prescription as a medicine, and there’s an abundance of evidence demonstrating the therapeutic value of the CBD molecule (and other cannabinoids), making medical claims about over the counter CBD products is strictly forbidden by the MHRA. The MHRA states that typically, levels of CBD studied for the purposes of treating or preventing illness/disease are considerably higher than that of OTC CBD products.
Unlike THC, CBD is not a controlled substance. However, with the new Novel Foods regulation in place, unauthorized CBD products cannot be legally sold in the UK. To be able to sell in the UK market, you must follow the GB regulated product authorisation process.
You can view all CBD products that are currently authorised in the Novel Foods Catalogue.
A vast number of people in the cannabis industry have reservations about the benefits of this process, and concerns over a ‘flawed process’. These worries include the risk of ‘a monopoly being created’ and the stark issue of regulations keeping UK hemp farmers out of the industry, therefore keeping CBD products as imports only. Furthermore, a number of clerical errors made by the FSA and confusion over the compliance of white-label, re-branded products has left company owners with their nose out of joint.
Nicholas Earles, COO, Foodtech Compliance, recently wrote on the subject for The Grocer, and proposed that ‘judicial review may now be the only available option for those companies that feel aggrieved by the FSA’s actions’. However, he goes on to say the only judicial review initiated against the FSA that he’s aware of ‘didn’t make it past the ‘leave to appeal’ stage, with the court finding firmly in favor of the FSA.’ And that ‘increased regulations create consumer confidence, which in turn brings market stability.’
Herein lies the up-side to Novel Food Regulation and the importance of it in the CBD sector. The CBD market undoubtedly needs regulating – products should be tested, thorough lab reports must be made to ensure that the product is free from contaminants and meets legal requirements. According to an ACI survey, 45% of UK consumers said they were not confident that CBD was properly labelled or tested. 74% support the decision by the FSA to regulate the CBD market more closely, and quite rightly so. Just as long as this prohibition, with a view to keeping ‘safe’ products on the shelves, doesn’t diminish innovation or interest in the market as a whole.
Fortunately, the appetite for quality CBD products is clearly widespread in the UK. Despite all the difficulties, the industry continues to blossom at an impressive rate, and new entrants to the market appear undeterred. According to the Centre for Medicinal Cannabis, the UK CBD industry is on track to reach an eye-watering £1bn by 2025, with no signs of slowing down.
So, what’s next for companies who want to enter the world of UK CBD, or for existing brands who want to keep their products on the shelves? Is Novel Food authorisation essential, or is it possible to sell CBD products without it?