UK food safety watchdog the FSA has moved to clarify the responsibilities of businesses producing cannabidiol (CBD) products. The CBD industry must submit a ‘valid novel food authorisation application’ by 31 March 2021. Only products that have commenced the application process will be allowed to remain on the market after this date.
“CBD products are widely available on the high street but are not properly authorised. The CBD industry must provide more information about the safety and contents of these products to the regulator before 31 March 2021, or the products will be taken off the shelves,” FSA CEO Emily Miles warned.
Speaking to FoodNavigator, a spokesperson for the regulator confirmed that finished product manufacturers will not necessarily need to apply for approval themselves. However, they will be required to prove safety and stability of the CBD ingredient within the final product application.
“If your supplier has made a valid application before the deadline, you are covered… Novel food applications should outline uses of the product. You can’t use the [CBD ingredient] for anything other than what is covered in the application.”
Ending regulatory uncertainty and addressing safety
The statement aims to bring to end a period of regulatory uncertainty for CBD and chart a path to compliance for the industry.
In the European Union CBD falls under the Novel Food regulation, meaning it requires pre-market authorisation.
However, some industry bodies and CBD manufacturers question this. They argue that the process of extraction – and whether it was used in the EU before 1997 when the Novel Food regulation came into force – determine whether the ingredient should indeed be defined as a Novel Food.
What is CBD?
CBD, a chemical found naturally within the cannabis plant, was added to the Novel Foods Catalogue in January 2019.
Unlike THC, which is responsible for cannabis’s ‘high’, CBD is not psychoactive.
It has been linked to a number of positive health outcomes. In medical uses, robust evidence points to its use in treating some symptoms of childhood epilepsy, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS).
In the FMCG space, CBD is commonly associated with reducing anxiety, insomnia and different types of chronic pain. The ingredient has made its way into a range of finished products, including oils, confectionery, bakery products and drinks.
To complicate matters further, each EU member state can take an alternative position because the Novel Food Catalogue is not legally binding. Prior to its most recent announcement, the UK’s FSA had not taken enforcement action to remove unauthorised CBD products from the shelves.
Concerns about the quality and safety of an under-regulated CBD category have also been mounting.
The FSA itself highlighted questions over CBD's safety this week when Miles warned ‘CBD could be risky for vulnerable groups’ – such as pregnant or breastfeeding women - and suggested an upper limit of 70mg a day for everyone else taking the product.
Professor Alan Boobis, chair of the Committee on Toxicity, added that a review of the evidence on food products ‘found evidence there are potential adverse health effects’ associated with consumption.
“We don’t know enough to be sure about such a risk but I am pleased with the sensible and pragmatic approach the FSA is taking. The committee will continue to keep these products under review in the months ahead.”
Novel Foods: Trial by fire?
Patchy enforcement alongside concerns over safety and quality present something of an existential threat to the nascent CBD sector.
Consumer interest in the space has been propelled by perceived health benefits. But if suppliers fail to provide safe and high-quality products, the industry could face a significant backlash.This risk prompted some industry watchers to welcome the FSA’s move. As Katie Vickery, head of food law at Osborne Clarke LLP noted, the announcement ‘provides businesses and consumers with some much needed clarity on the position of CBD in foods’.
Meanwhile, the Cannabis Trades Association (CTA) said it ‘duly welcomes’ a route to compliance for the industry. “The CTA fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain on in stores across the country,” it said in a statement.
However, there is a caveat: “We are still of the opinion that natural (not isolates or synthetic forms) CBD products do not fall under the scope of the Novel Food schedule,” the industry association argued. “In reality, not all members will be affected by the proposed legislative changes.”
Dr Parveen Bhatarah, regulatory & compliance lead at the Centre for Medical Cannabis (CMC) takes a different view. “As a part of a Novel Food application dossier, your extraction techniques need to be detailed if you are the raw material supplier. It is about safety - to show you have full understanding of the process, you understand the stability of the product and there is full traceability of supply chain, so the consumer is never misinformed.”
According to Dr Bhatarah, who warmly welcomed the FSA’s announcement, all CBD suppliers regardless of extraction method need to gather appropriate safety data and submit their Novel Foods applications ‘ASAP’.
But Sarah Ellson, a regulatory partner specialising in life sciences at European law firm Fieldfisher, believes securing approval may prove something of a ‘blow’ for CBD operators.
"The reality of getting authorisation for a novel food from the FSA and EFSA is burdensome and involves a dossier of scientific data that may seem similar to getting a medicine authorised.
"While this may be frustrating, it should be remembered that the rules are set in the interests of public safety, and that attempting to sidestep or antagonise regulators could have serious consequences for individuals, companies, and the CBD industry as a whole,” she warned.
An evolving environment for CBD
While the route to compliance may now be clearer, industry representatives noted that the development will alter CBD market dynamics.
For instance, Dr Bhatarah believes that increased regulatory rigour will help address some of the major points of controversy within the CBD world. Namely, a lack of standardised testing procedures and safe dosage data. “I feel it will standardise the testing methods and initiate safe dose evaluation. This is the best outcome for consumers as well as the suppliers, as the responsible suppliers are already working on this,” he told FoodNavigator.However, it could have a downside for smaller companies operating in the CBD space. Robert Verkerk, founder and executive and scientific director at the Alliance for Natural Health, suggested that the expense of securing novel food approval could prove cost-prohibitive for smaller companies operating in CBD.
“While ‘all’ any operator needs to do to be allowed to continue selling CBD products is submit a valid novel food application, a valid application is still going to be cost-prohibitive for many of the smaller players… There will inevitably be some that will find themselves in the cross-hairs of the FSA come the end of March 2021.”
The Alliance for Natural Health is currently ‘seeking legal views’ on whether the FSA’s approach is challengeable if it transpires the deadline has ‘disproportionate impacts’ on ‘small businesses selling high quality, correctly labelled and safe products’, Verkerk told this publication.
Nevertheless, Dr Bhararah, who has links to the UK-based Association for the Cannabinoid Industry (ACI), believes that the completion of a dossier within the FSA’s timeframe should not prove too great an obstacle.
“Responsible suppliers of CBD should have the process and stability data already. If they do not, then they can generate the six month accelerated stability data. They can send it for initial genotoxicity studies which takes about eight weeks. The longest time required is to generate a safety study for dose evaluation & amount of bilirubin produced during these trials. This will require a 90 day study and could take eight-to-nine months. All these things can happen in parallel,” he suggested.
How well players of various sizes will cope with the FSA's requirements remains to be seen as all eyes turn to 31 March.
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