The UK FSA Takes A Big (Baby) Step in the Regulatory Advancement of CBD Products

It’s over 3+ years since a great many companies submitted CBD Novel Food applications to the UK FSA and today (29/4/24) we have the first two recommendations for Authorisation for its use at up to 10mg as Food Supplements, in various delivery mechanisms – capsules, liquid, gummy and beverage.

Firstly, we should congratulate the UK FSA and FSS for having the ability to make a decision that the EU Commission/EFSA is so unwilling to make that they have halted all consideration of such applications and demanded the production of data which is as self-contradictory in its nature as it is impossible to obtain in the context of what is it being said to be required to establish.

However, it is to be noted that each of the Applications recommended for Authorisation is limited to 10mg, which certainly wouldn’t have been their respective starting points. This begs the question whether they were required to compromise pursuit of what their science told them in order to achieve regulatory advancement and secure market share, be unshackled from the Public List (thus “moving on” and avoiding the continued spotlight pursuit of the Hemp Hound Agency) and seek to take commercial advantage from being the first “fully regulatory approved” products into the market?

At AFR we currently have Client applications progressing within the Risk Assessment phase which undoubtedly demonstrate safety at 50+ mg per day – because the we designed the Tox Studies to ensure multiple strata to have a closely constrained NOEL point rather than a rock-bottom one. Those Clients indicate to us that they intend to “Stand By Their Tox” and resist any attempt by the FSA to force them into what is becoming the regulator’s “comfortable norm” of 10mg per day.

As we understand it the two recommended applications could also prove safety beyond that which they eventually accepted and/or has been imposed upon them. If that is correct, then it sounds very much like they were left with the choice of “be Authorised quickly at 10mg or don’t be Authorised at all and we will consider your application once we have ploughed through all of the 100+ other applications and seen if those applicants will accept what we propose, while we use their collective data to update our initial safety assessment”. If that is right then it would seem that the FSA/ACNFP/COT are seeking to corral applications into the 10mg position, with the potential promise of “we will look again when we have eradicated the backlog and collated all of the safety data which is within all of the applications”.

A word of warning for those who consider the compromise in the hope of a swift re-assessment: we have recently been involved with a non-CBD Novel Food re-assessment in respect of an increased daily intake of the Novel ingredient. The initial Authorisation took place in 2013/2014, the application for a re-assessment vis-a-vis an increased dose was made in 2015/2016. It was granted in 2023, despite all of the data being available at the point of the re-assessment request.

Those who compromise may be swift to market and reap the rewards afforded to those who are, but those who hold out and establish a 50+ mg daily intake level will have price economies of scale, improved shelf space benefits, much lower price per mg and hence much greater profits. There may well be a lot of companies with decisions to make – remain on the public list (with your existing higher dose product) and fight hard for Authorisation at 50+ mg, or compromise at 10 mg (as they will undoubtedly be pressured to do), have minimal functional benefit, but be able to claim “Authorisation”?

Remember what we always say: Be Careful Who You Listen To.