CBD products already on the UK market are safe for now, as the country's Food Standards Agency says it will not take action while it works out how to implement the new European Union novel food regulations.
The UK Food Standards Agency will not seek to remove cannabidiol (CBD) products currently being marketed in the UK while it works out how to enforce European Union regulations on novel foods.
“We have not been made aware of any safety incidents relating to CBD products on the market, so we are not planning to insist on an immediate removal of the products from shelves,” insisted the agency’s new CEO, Emily Miles, at a board meeting earlier this week.
“That said,” Miles continued, “it is important that industry puts these products through the authorization process as the process is there to establish more information about the products and their safety, to confirm that the products are what they say they are, and therefore to protect consumers.”
The FSA would “keep this position under close review,” Miles reassured the FSA board. But in the interim, she urged industry to “bring these products into compliance with the law.”
FSA Working As “Fast As Possible” On Implementation
The report was Miles’ first since joining the agency as CEO last year. Before taking the reins at FSA, Miles oversaw the food-related aspects of the UK’s exit from the EU within the Department for Environment, Food and Rural Affairs, as acting director-general for the EU Exit Delivery Group.
Since the European Commission decided CBD should be classed as a novel food, and should be regulated as such within the EU, the FSA had been considering how to enforce this law, Miles revealed at the board meeting.
Work on implementation was “progressing as fast as possible,” she maintained, however, the cross-departmental nature of the issue meant that it was “not within the gift” of the FSA to provide a specific timeline for implementation.
While the FSA was ultimately responsible for the regulation of these products as foods, Miles insisted that it was important to consider the “wider aspects” of how to implement the new rules.
To this end, the FSA had been working closely with other UK Government departments to finalize its position, roles and responsibilities, and specific guidance to those enforcing the novel food regulations, she explained.
No Risk? Really?
In the interim, the UK CBD market had “grown rapidly,” Miles noted, with products now available on the high street “in the form of tinctures, tablets, oils, and also in everyday foods such as sweets, drinks and bakery products.”
“If you are thinking about trying CBD, or are already a user, please bear in mind that these products have not yet been formally authorized by the food regulator,” was Miles’ advice to consumers.
However, Miles’ confidence in the safety of products currently on the UK market contradicts that of other organisations attempting to bring order to what remains a very confusing situation.
The UK’s Centre for Medicinal Cannabis last year found a shopping list of efficacy and safety issues in an analysis 30 CBD oils marketed in the country, including:
Measurable levels of THC (mean content 0.04%) in almost half (45%) the oils, which meant that according to UK law, they were technically illegal.
Less than 50% of advertised CBD content in 11 of the oils, with one product sold in a high street pharmacy containing 0% CBD yet retailing for £90 ($110).
Substances with no therapeutic value in many of the oils. For example, one product contained 3.8% ethanol and seven contained levels of solvent dichoromethane above food limit safety levels.
“The results are highly revealing and provide a good overview of the true nature of the CBD products being sold in the UK,” commented the CMC. “They reveal a wide range in terms of quality, and poor practice in a minority of cases.” (Also see "UK Body Calls For 'Clear Guidance' On THC Levels In CBD Oils" - HBW Insight, 12 Jul, 2019.)
Meanwhile, the UK’s Medicines and Healthcare products Regulatory Agency has been less reluctant to act, issuing a total of 20 emergency notices to CBD supplement manufacturers within 11 months (see table below), including eight “urgent” Regulation 165 notices, which are issued by the regulator when products not authorized to be marketed in the UK “pose a risk to patient health.” (Also see "UK Cracks Down On Unauthorized CBD" - HBW Insight, 6 Nov, 2019.)
MHRA Regulation 165 'Other' Notices Issued To CBD Manufacturers, November 2018 - September 2019
PROPORTION OF REGULATION 165 'OTHER' NOTICES TO CBD MANUFACTURERS OPERATING IN THE UK AS A PROPORTION OF ALL 'OTHER' NOTICES ISSUED BY THE REGULATOR DURING THE PERIOD (Source: MHRA)