UK CBD update: FSA issues first positive safety assessments in Novel Food process

Cannabis Health
Wed, May 8

Chanelle McCoy’s subsidiary, Pureis, became the first company in the UK to receive a positive risk assessment for a synthetic CBD application on April 29, 2024.

Cannaray similarly received the first ever positive risk assessment for its isolated CBD application, meaning both can now move on to the next stage of authorisation, risk management.

Each have hailed the development as a ‘milestone’ for both their brands and the wider CBD industry, which has also largely welcomed the news.

It marks the first meaningful development in the UK’s CBD novel food in over a year, and signals that the FSA could finally be making progress on its backlog of applications, which have kept the industry in stasis for a number of years.

Cannabis Industry Council Co-Chair and CBD/Hemp APPG Secretariat Lead Jamie Bartley and CIC CBD Working Group Chair Damien Bove told Business of Cannabis: “The Cannabis Industry Council welcomes the start of CBD product authorisations by the Food Standards Agency, which have been long overdue.

“The consumer CBD industry has been in a state of limbo for some time, which has harmed its economic prospects, and prevented a level playing field in the market.

“We hope these approvals will lead to a step change in the authorisation process, with many other products granted safety approval in the very near future.”

The FSA (and Food Standards Scotland) concluded, along with support from the Advisory

Committee on Novel Foods and Processes (ACNFP), that the two applications had ‘provided sufficient information to assure the novel food(s)… were safe under the proposed conditions of use’.

“The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous,” the FSA reported.

Chris Rundle, Head of Regulated Products Risk Assessment, Food Standards Agency, said: “The FSA and FSS have published the outcome of safety assessments for two CBD novel food applications with 98% CBD. The assessments have concluded that these CBD novel foods are safe when consumed in line with our consumer advice, at up to 10mg of CBD per day. These applications will now move to the next stage of the authorisation process.

“The FSA and FSS are the first regulators to complete and publish safety assessments for CBD as a novel food. The progress of these applications shows the importance of applicants providing quality data which supports the assessment and authorisation process.”

Chanelle McCoy, CEO of Chanelle McCoy Health, who suggested the brand has been working for nearly a decade to get to this point, said that the brand was now poised to expand its product portfolio

“This is a monumental achievement and a complete game-changer for the CBD industry,” she added.

In a statement on social media, Cannaray’s Managing Director Howard Radcliffe said: “We are proud to be at the forefront of driving innovation and establishing best practices within the UK CBD industry.”

The Cannabis Trades Association (CTA) said that they were ‘delighted to see that at last the FSA are clearing the decks of historical dossiers that have been on the ACNFP agenda since February 2024’.

“We obviously see this as good news with the revised novel foods process for CBD and other foods coming in to force by June.”

However, the industry trade body noted that, having read the full report on Cannaray’s application, ‘the lower limits are not supported by the recommendation’.

“This is for isolated and synthetic CBD as a food ingredient only… Our understanding is that the revised novel foods process will come into effect in June and that bulk ingredients, providing they conform to 50 micrograms of cannabinol and an ADI of 10mg CBD which will be subject to change as more data becomes come available.”

In October last year, the FSA published a shock update to its consumer guidance on the recommended daily dosage of CBD.

According to new ‘scientific evidence’, understood to have been gained from toxicological studies submitted by the industry itself, the FSA dropped its recommended daily intake from 70mg to just 10mg.

This meant that many single dose products such as CBD beverages, capsules and gummies will now contain levels of CBD over the new limit.

Industry stakeholders quickly raised concerns about the move, calling it ‘heavy handed’. Both of the successful applications adhere to this limit, raising questions about applications which cross this threshold.

Days later, in a response to the ACMD report published on 24 October, Minister for Crime and Policing, Chris Philp MP, said the government intends to accept the advised limit of 50 micrograms of THC and other controlled cannabinoids per unit of consumption.

A unit of consumption or ‘single serving’ is defined as the typical quantity of a CBD product consumed on one occasion, however representatives in the industry have expressed the need for further clarification on what constitutes a typical serving of CBD.

The FSA published the ‘public list’ of validated CBD applications in June 2022, and continued to validate compliant applications for months after.

This detailed all the CBD product applications that met the FSA’s rigorous and costly requirements for official authorisation.

Those that were successfully included in the public list were allowed to remain for sale on the market while undergoing a multi-stage safety assessment process, but no companies have been unable to bring any new products to market until this authorisation process has been completed.

With the industry stuck in limbo, the FSA’s lack of clarity, repeated delays and moving of goalposts has led to considerable frustration from an industry struggling to keep its head above water financially.

As such, news that applications have now moved forward holds extra weight, though it’s unclear if the FSA will achieve its target of granting its first official authorisations this summer.

Now that the products have made it through the risk assessment process, they’ll move onto the risk management phase.

According to the FSA, this will consider ‘other legitimate factors in its use like labelling considerations; and a public consultation prior to sending advice to ministers across the nations on whether to authorise.’

“Subject to Ministers’ approval, the authorisation is written into legislation and laid as statutory instruments which are subject to Ministerial scrutiny before the authorisation comes into force.”

However, this final phase could soon be streamlined amid proposals to overhaul the novel foods process in an effort by the FSA to address the industry’s frustrations, and enable regulation to keep up with developments in the space.

This article was originally published by Business of Cannabis and is reprinted here with permission.