Industry demands closure to CBD regulation stalemate
Five years on from the European Commission’s declaration that food and supplements containing CBD were to be considered as novel foods, and four years since the FSA followed suit, the future of thousands of products and an entire sector now hangs in the balance thanks to a slow and unorganised regulatory process, the association warns.
"A lot of people invested in this process in the hope they would eventually stay on the market and flourish but people have been left waiting for years for feedback on their applications," Steve Moore, ACI co-founder, told NutraIngredients.
All this time, these companies have been unable to bring new CBD products to market, and legality has remained uncertain for brands, suppliers, customers, retailers and investors—with the latter perhaps having the most impact on the industry.
He explained that the Home Office and the FSA have been working in silos due to the fact one is concerned with drugs while the other deals with food, leading to confused and slow regulatory decisions.
"The processes have taken too long, become too confused and have not been sufficiently co-ordinated," he added. "The agency and the department should take account of the recommendations in this report. Together they provide a path to expedite the legal and regulation frameworks the industry has been crying out for and invested millions of pounds towards progress."
CBD Novel Food History
2019 - The European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids were to be considered as novel foods.
As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) were regarded by the European Commission as novel.
Contemporaneously, the FSA committed to implementing a process for accessing Novel Food applications.
February 2020 - A policy for implementing this process was announced, and a deadline for applications to the FSA was set for 31 March 2021.
January 2021 - The Home Office stated its intention to establish a legal framework for consumer CBD products in a commissioning letter to the Advisory Council on The Misuse of Drugs (ACMD).
The ACMD response was published in December of that year.
12 October 2023 – The FSA says, “based on the average lifetime exposure to food products containing CBD”, healthy adults should limit their consumption of CBD (>98% purity) from food or beverages to 10 milligrams per day. That’s equivalent to four or five drops of a 5% CBD oil.
24 October 2023 – The Home Office accepted the position of the ACMD in December 2021, which recommended that legislation be updated so that CBD ingestibles can legally contain up to 50 micrograms of controlled cannabinoids (including THC) per unit of consumption or serving.
The report provides six key steps needed to provide stability for the industry.
1. Consider more data in reassessing the CBD daily limit
The report states that the COT and ACNFP should evaluate further data and re-evaluate the recently revised accepted daily intake (ADI) for CBD of 10 micrograms per day (down from 70mg).
Paul Duffy, toxicology associate at the ACI and co-author of the report, explained that the recommendation is based on just three novel foods dossiers but with so many applications now made, there are a wealth of dossiers with data which will show higher safe levels.
“We’ve asked them to consider more data in coming up with this number because they only refer to three data sets, and we know they have a lot of other applications to work through,” he said. “We’ve asked them to provide more transparency on how they’ve come to this level in terms of their toxicology methodology.”
2. Provide clarity on suggested THC limit
The Home Office added a further bombshell to the market in October when it finally accepted a recommended limit for THC (a recommendation provided by the Gov’s Advisory Committee on the Misuse of Drugs back in December 2021).
However, the advice created some confusion as it stated that any CBD product must limit the content of controlled phytocannabinoids so that they do not exceed 50 micrograms “per unit of consumption”.
This led the industry to point out that providing a new THC limit based on a ‘per serving’ essentially means you could have a product with concentrated THC if considering a product such as a tincture which has several servings per bottle.
The ACI document therefore recommends that this 50 microgram limit should relate to a maximum total daily intake for controlled cannabinoids as opposed to per serving or per unit of consumption.
3. Put these in ink before 2024 General Election
The report states that The Home Office must obtain Ministerial approval to implement the THC recommendations into law by April 2024.
“Any significant deviation from these recommendations will cause further extensive delays, and investors will continue to withdraw from the British market,” it noted.
4. Set a standard toxicology methodology
The ACI recommends that a small working group of experts convene to urgently review and propose specific analytical methodology that the FSA can rely on in evaluating the acceptability of CBD product quality and safety.
Greer Deal, co-founder and director of GRS (Global Regulatory Services) and co-author on the report, explained that without any set standard, companies can choose whatever testing method gets them their preferred outcomes.
5. Keep all products on Public List
The ACI requests that the FSA retain the Public List of Novel Foods applications online until the last application has been assessed, with a fourth available ‘status’ field – “Authorised”.
Currently, the FSA plans to remove products from the Public List once they are authorised, but Moore suggested this could be more confusing for consumers and retailers who need to be able to see the status of all these products in one place.
6. Timeline transparency
Once the daily intake limits for CBD and controlled cannabinoids (including THC) are defined, the FSA should announce a timetable to complete its review of Novel Food Applications and in priority of the previously defined Groups—A, B and C.
