The Food Standards Agency’s (FSA) move to better regulate the CBD market also includes dosage recommendations which have been described as “absurd’ and “based on no evidence”.
Some cannabis industry bodies have welcomed the FSA’s recent intervention, however, describing it as a much- needed step towards clearer regulation in the UK CBD market. The FSA has given the CBD industry a deadline of 31 March 2021 to submit valid novel food authorisation applications.
A novel food is defined as a type of food that does not have a significant history of consumption or is produced by a method that has not previously been used for food. While hemp-based foods have been consumed for thousands of years, and are deemed non-novel, the novel food status of CBD extracts was confirmed in January 2019. After 31 March next year, only products which have submitted a valid application will be allowed to remain on the market. The authorisation process ensures novel foods meet legal standards, including on safety and content, the FSA says.
Local authorities enforce the novel food legislation and have been advised that businesses should be able to sell
their existing CBD products during this time provided they are not incorrectly labelled, are not unsafe to eat and do not contain substances that fall under drugs legislation. In addition, the FSA has advised those who are pregnant, breastfeeding or taking any medication not to consume CBD products.
It has also recommended that anyone takes no more than 70mg a day unless under medical direction – advice which has been questioned by one expert.
“This is daft and totally without any evidence whatsoever. None,” says Professor Mike Barnes, chair of the Medical Cannabis Clinicians Society.
He adds: “Since the efficacious dose in adults is about 60- 100mgs that makes no sense. The FSA suggests not taking CBD with any other medication despite an excellent safety profile. They say they draw from a recent report from the Committee on Toxicity, which suggests nothing of the sort.”
Professor Barnes also has concerns about the potential impact of the new guidelines on the UK’s burgeoning CBD retail market.
“This could decimate the CBD industry. It will remove a good medicine from hundreds of thousands of people who are benefitting from it.
“The sellers can’t make medical claims now but nevertheless it is a medicine that helps so many people with pain, anxiety, sleep and appetite, let alone epilepsies. Some CBD can be prescribed but that, as we know, is so tricky and frankly impossible on the NHS and very expensive privately.
“For sellers to apply for novel food authorisation, it will be very expensive and very time consuming. This plays into the hands of ‘big cannabis’ who can afford the potential cash flow issues and expenses, and it just drives the small artisanal guys off the shelves.”
Peter Reynolds, head of Canna Pro, a trade association for UK cannabis, CBD and hemp businesses, also has misgivings about the FSA’s latest actions.
He told the press: “In one sense this announcement is good as now the industry knows where it stands. It was in 2017 that I first started talking to the FSA and they have changed their minds repeatedly, shifting its position over and over again. Finally, they have now actually done something.
“The maximum recommended dose for CBD food supplements is 200 milligrammes. So, the differences are so vast they are just absurd.
“The whole thing is preposterous. The FSA have failed to respond to any correspondence from CannaPro for the past six months. They obviously feel under pressure to do something. They have used the phrase ‘novel’, but these products are not novel.
“I think anybody selling whole CBD extract products can just continue. The crucial part is that if they really had any genuine concern about safety, how could they possibly give people only a year to submit an application?”
Another UK body, the Cannabis Trades Association (CTA), was more welcoming of the news, however. In a statement, it said: “Although [we] duly welcome a route to compliance for the industry and its members, we are still of the opinion that natural products (not isolates or synthetic forms) do not fall under the scope of the novel food schedule.
“The CTA fully supports regulation as it ensures consumer safety and gives clarity to the processes required for its members’ products to remain in stores across the country. We are continuing a full review process including legal aspects and avenues into the current and proposed regulations for CBD in the UK, whilst maintaining close relationships with relevant authorities and stakeholders. In reality, not all members will be affected by the proposed legislative changes.
“Further to the highlighted safety concerns, the CTA agree that CBD as a food supplement should not be administered in high daily doses (above 200mg), and consumers should always seek approved medical guidance if taking other medications or during pregnancy.
“We also maintain our position that CTA members’ products are compliant and continue to pose no safety 11 concerns to those consuming within the set guidelines.
“In summary, although we do not agree in full with all that is being proposed, we believe it is a positive step towards ensuring consumer safety and that CBD will be on the shelves for many years to come.”
Explaining the FSA’s stance, its chief executive Emily Miles said: “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.
“Also, we are advising that CBD could be risky for vulnerable groups, and suggesting an upper limit of 70mg a day for everyone else taking the product.
“The actions that we’re taking are a pragmatic and proportionate step in balancing the protection of public health with consumer choice. It’s now up to industry to supply this information so that the public can be reassured that CBD is safe and what it says it is.”
Professor Alan Boobis, chair of the Committee on Toxicity, said: “My committee has reviewed the evidence on CBD food products and found evidence there are potential adverse health effects from the consumption of these products. We are particularly concerned about pregnant
or breast-feeding women and people on medication.
“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.”