Can regulators keep pace with CBD innovators?
When is an illegal food and beverage item not an illegal food and beverage item? The answer: when it’s a product containing cannabidiol (CBD) marketed for sale in the UK. That’s the somewhat unconventional situation the UK’s Food Standards Agency (FSA) is presiding over following the decision to allow around 12,000 products made with CBD extracts to remain on the market while their safety is fully assessed. Other regulators have not been so flexible. Any CBD products classed as novel foods are still banned in the EU, and therefore in Ireland, while suppliers await the first successful application to sell their products legally within the bloc.
Questions over how to regulate CBD food and drink products have bubbled to the surface following their emergence on the Irish and UK markets from around 2016. The extent to
which they should be granted market access has been a source of debate and contention across the world as regulators grapple with uncertainties over the risks associated with their consumption and the overlap with other regulatory spheres such as narcotics and medicines. So how are food regulators tackling this complex issue?
Novel or not?
Some naturally derived products from the hemp plant such as hemp seeds and hemp seed oil are not considered novel since there is evidence to show a history of consumption before May 1997. This ceases to be the case when these products are refined, and the selected components added to food and drink as an ingredient. CBD sold as food, or as a food supplement, features in products such as oils, gel capsules, sweets and confectionery, bread and other bakery products, and drinks – the latter being a particular focus of new product development. The CBD used in these products is mainly extracted from cannabis flower and leaves and the resulting product referred to as ‘CBD isolate’. CBD itself is not classified as a narcotic drug, however in trying to maximise the CBD content of the isolate it retains traces of other phytocannabinoids including those that are treated as controlled substances. The most well-known of these narcotics is tetrahydrocannabinol (THC), the substance that gives cannabis smokers a high.
Playing catch up
In some respects, regulators are playing catch up with a market that is already generating considerable interest among consumers. A recent survey commissioned by The
Grocer magazine of 4,000 UK consumers found widespread awareness of CBD products. Just under three-quarters of those surveyed (73%) said they know what CBD is, while 20% said they consume CBD food and drink. A significant proportion – 38% – also believed that CBD is good for overall health, according to The Grocer’s research. Although
no specific health claims have been approved for CBD products at EU level, some studies suggest it has potential to contribute to improved physical and mental health by providing pain relief and relieving anxiety and depression. A 2015 animalbased study from the European Journal of Pain concluded that CBD has therapeutic potential for relief of arthritis pain-related behaviours and inflammation without evident side-effects. Yet there is also evidence of CBD consumption being linked to side effects including nausea, fatigue and irritability.
Safety risk
Moreover, certain illegal products pose a potentially serious risk to public health. The sale – often online – of sweets and gummies containing high levels of THC has been a source of significant concern for regulators and enforcement bodies. In these cases where a significant amount of THC has clearly been intentionally added to a product as a recreational drug, the applicable law in Ireland is the Misuse of Drugs Act, 1977, rather than food law. Where a low level of THC is inadvertently present in hemp-based foods it is considered a contaminant and can be managed using various provisions in EU Food Law.
“We were planning to do some work on the safety aspects [of THC] but we are leaving that to those government agencies who are already actively engaged in that area. We are focused on the hemp and CBD food products on the market now,” says Dr Pat O’Mahony, Chief Specialist, Food Science & Technology at the Food Safety Authority of Ireland (FSAI).
Even products sold in good faith could breach various food safety and authenticity rules. A national survey of CBD products coordinated by the FSAI in 2019 and published in 2020 found that the majority of products analysed were in breach of various articles of food law and some posed potential safety risks for consumers. Among the findings were that 37% of the products tested had levels of THC that if consumed at the maximum recommended dosage could significantly exceed the safe limit set by the European Food Safety Authority (EFSA) of 1 microgram/kg/body weight/per day. Around a third (34%) of the samples were classified as novel foods and should not have been on the market at all, while 41% contained CBD levels which differed by more than 50% compared to the declared level.
Dr O’Mahony says the FSAI has had occasion to remove a number of CBD products from the Irish market that breached food law, adding that problems often relate to new start-up companies who haven’t yet acquainted themselves with the relevant legislation.
New advice
At the moment there is no safe upper limit established for CBD products in Ireland and the EU – a consequence of there being an absence of data since no products are currently authorised for sale on the market. In the UK, the FSA recently updated its precautionary advice to recommend that healthy adults should limit their consumption of CBD from food to 10mg per day, equivalent to 4-5 drops of 5% CBD oil and a sharp drop from the previous 70mg per day recommended limit. It said the change in advice was based on new evidence from the industry and updated advice from its independent scientific committees, including evidence of some adverse impacts on the liver and thyroid over a period of time. The FSA continues to advise that CBD is not taken by people in vulnerable groups, including children, people taking medication and those who are pregnant or breastfeeding and those trying to conceive.
“The more CBD you consume over your lifetime, the more likely you are to develop long-term adverse effects, like liver damage or thyroid issues,” says Professor Robin May, Chief Scientific Advisor at the FSA. “The level of risk is related to how much you take, in the same way it is with some other potentially harmful products such as alcoholic drinks.”
The new FSA guidance has provoked an angry response from the CBD industry. In a statement, the Cannabis Trades Association expressed concern, arguing that nowhere in the
FSA’s press release did it explicitly state that the guidance was merely advisory and that the lack of clear communication may lead consumers and retailers to interpret it as a mandatory limit. It also suggested that foods already on the market currently adhering to the previously recommended daily upper limit of 70mg per adult are now in a state of limbo.
There is concern too among businesses over “the very narrow range of evidence the FSA considered when coming to the conclusion over its guidance”, says Dominic Watkins, global head of consumer sector at law firm DWF.
Pragmatic approach
Suppliers of CBD food and drink products are used to run-ins with the regulator. Brands have been battling for years to have their products authorised for legal sale – to date without any success within the EU. The UK has taken a slightly different approach following Brexit and the creation of its own bespoke novel foods regime. Cognisant of the mainstream market that has already developed for CBD products, the FSA has taken a pragmatic view and drawn up a list of around 12,000 CBD products currently going through the novel foods authorisation process. These include products that were on the market prior to 13 February 2020 for which the FSA had received an authorisation application before 31 March 2021 and for which the application is considered to be sufficiently progressing towards validation.
Although the FSA is not endorsing the sale of any CBD food products, regardless of whether they are on the list (those not on the list should be removed from sale), the process in effect means listed products can be marketed in England and Wales prior to receiving formal regulatory approval. A key question now, according to Watkins, is what impact new
consumer guidance to limit consumption of CBD from food to 10mg per day has on the evidence companies have provided to support their product applications. “There will be businesses who have gone ahead and produced studies that work on the basis of the previous 70mg limit,” he says. “If the implication is that a product with CBD content above the new level of 10mg is unsafe that raises questions over how the market will move forward.”
The UK government for its part does seem intent on establishing a legal framework for the sale of CBD food and drink products. The Home Office is seeking to control the presence of THC in CBD products with the aim of preventing any pronounced psychoactive or psychotropic effects and ensuring consumer safety. The government recently accepted the recommendation from the Advisory Council on the Misuse of Drugs that the total dose of delta-9-THC and all other controlled phytocannabinoids in consumer CBD products be limited to 50mg in a unit of consumption.
As for the future prospects for CBD food products in the EU market, Dr O’Mahony is doubtful that novel food approvals are close for hemp-based CBD food products since the hemp plant contains more than 100 cannabinoids, the vast majority of which are as yet uncharacterised and whose safety may be difficult to establish. He does however believe that products containing synthetic CBD – a form of CBD that is made in a lab using biological or chemical processes – could be closer to a safety assessment outcome since more data is available for that single CBD constituent.
For the moment, in Ireland and to a lesser extent the UK, the CBD market is effectively in stasis while regulators decide whether these emerging food and drink products have a
legitimate contribution to make to our future diets.
