Are the Food Standards Agency (FSA) right to stop companies from updating their labels to reflect last year's consumer safety (ADI) update?
In April this year, it was relayed to me that the head of novel foods had attended a meeting where he stated three things:
1 - The FSA is engaging with the Advertising Standards Authority (ASA) to target medicinal claims
2 - The FSA is looking at product labels to ensure no one has altered them to reflect consumer safety advice they very publicly announced on 12/10/23
3 - The Advisory Committee on Novel Foods and Processes (ACNFP) is not happy with RP427
This is Part 2 of a three-part series that looks at those statements in depth.
Part 1 can be found here, and it asks why the FSA is engaging with the ASA, and not with the Medicines and Healthcare products Regulatory Agency (MHRA) to deal with companies who are making medicinal claims on their products.
That should be a hot topic right now, because there shouldn't be any medicinal claims on products that are not designed to diagnose, treat, or cure any condition, ailment, or disease.
But, the question is, will they target fairly? And that question is asked on the basis of most if not all companies within the inner circle being part of R&D programs that focus on CBD vs. medical conditions.
Some of the inner circle has that information on their websites, alongside products and updates associated with novel foods.
It's also asked because the FSA has removed products from the public list for breaching novel food requirements, specifically those related to the CBD amnesty, despite the fact that they have validated and authorised applications that also breach those same requirements.
What's more, there are suggestions that indicate the FSA has allowed medical claims in the past, specifically for products from companies who were members of the Centre for Medicinal Cannabis (CMC) up until November 2019, and then for those tied in with the Association for the Cannabinoid Industry (ACI, launched by the CMC) after that, even though it's not in their remit to do so...
I became aware of those suggestions due to my past employment with the Cannabis Trades Association (CTA) between 2018 to 2020, who themselves were engaged with the MHRA up until March 2020 to create Guidance Note 8, otherwise known as 'A guide to what is a medicinal product'. Past there though, the MHRA has been pretty silent, even though their Borderline Medicines department is supposed to keep an eye on the industry, and that silence began just after the FSA announced novel food deadlines and requirements in February 2020.
In essence, the line between foods and medicines is beyond blurred, and to a point, you have to ask what part certain regulatory authorities have had in allowing companies to become complacent enough to make claims on their products.
After all, when it comes to claims, surely the FSA cannot sign off on them, and should be engaging with the MHRA, and not the ASA, when reporting companies for overstating?
Like I said, it's a hot topic, and something that every company in the hemp and CBD sector should be mindful of.
But just before I continue, let me just say that you don't need to shoot the messenger
Compliance in this area is a bugbear for me. There should be a certain amount that you can say about CBD products in way of general wellbeing, and that it can help with minor conditions.
That being said, compliance is compliance, and no claims are allowed. And if you are tapped on the shoulder, saying "Yeah, but that company over there is doing worse things!" will not get you off the hook.
That's why companies need to take stock, and decide whether they're selling a food or a medicine, because I believe that there was a reason why the MHRA went silent when novel foods was defined by the FSA, and I also feel there's a reason why the FSA are engaging with the ASA. That reason is called The TIGRR report, and the specifics can be found on pages 81 & 82, as well as 121 & 122, which deal with the MHRA controlling access to clinical trials and medicinal CBD and cannabinoid-based products, respectively.
"We're just waiting for the consumer to see your products as medicinal, that's when we'll be back to say hello" Dr Chris Jones, ex-Head of Borderline Medicines, 2018 at that years CTA AGM
But now it's time to address Part 2
On 12/10/23 the FSA announced an Advised Daily Intake (ADI) for Cannabidiol (CBD) of 10mg, in what could only be described as a well-orchestrated press campaign.
Whilst the FSA's intent was to get the word out to the consumer, there seemed to be very little engagement with industry stakeholders on the build up to that announcement. But then, the FSA has a habit of doing that, which is concerning in itself.
All the major tabloids ran with the story', as did the other mainstream media outlets like the BBC to Cosmopolitan Magazine.
In a nutshell, the FSA wanted the consumer to know about that ADI before the industry did, and you have to ask why.
But that's not the only question you should be asking!
Absolutely not. The other question is this: Why won't the FSA allow companies to change their labels to reflect the ADI they publicly announced to the consumer last year?
We all know that the FSA stated at the start of novel foods that companies would not be allowed to change their labels, as that would lead to a new product, that the FSA said would then be removed from the public list, and the CBD amnesty, as that was only open to products that were available to the consumer on or before 13/02/20.
But then, most know that according to EU regulations, novel foods should be about the ingredient, and not the finished product.
The same could be said when it comes to companies knowing that the two recently authorised applications for Pureis and Cannaray didn't qualify for the CBD amnesty as they had no branded products on sale on or before 13/02/20.
And that leads us to morals and ethics vs. the FSA's mismanagement of the novel foods process for CBD products
The FSA claimed that the ADI is not mandatory, but then they did launch a big press campaign to inform the consumer, and won't let companies reflect that advice accordingly.
So what the consumer sees now are a lot of products that exceed the 10mg ADI per recommended serving, and according to sources, that has had a negative impact on sales. What the consumer won't see is the FSA effectively holding a gun to business owners heads, whilst highlighting the consequences of changing labels, even if it is to reflect the FSA ADI announcement.
And remember, that all came from minimal consultation with industry stakeholders, and the engagement after the announcement was dismissive of that concern.
What's more, there are suggestions that the ADI is about to switch from being advisory to mandatory. The authorisation documents for Cannaray's and Pureis' applications, for example, both list that ADI announcement in references, next to all the data submitted by those companies to verify the safety of their products.
That's very significant, and says to me that as soon as the inner circle has had their applications authorised, any product exceeding 10mg of CBD per serving will be removed from the novel food process.
But the consumer won't see that, because the FSA intends to reformat the public list soon so that it only houses authorised applications...
I sense a cull is about to occur, and it all comes down to the FSA not allowing companies to adjust their labels accordingly to reflect that ADI advice.
But that's not the only problem here. See, in the coverage of the FSA's announcement, it's stated through backlinks that the ADI came from three toxicology reports.
Those reports are all but confirmed to be from Pureis, Cannaray and EIHA.
It was further announced that those reports covered synthetic and isolated CBD, but despite that, the ADI was to apply to all CBD products even if they weren't made with those two extracts.
The problem there is that, according to Emily Miles, CEO of the FSA, approximately 200 novel food applications have been submitted.
All will have toxicology data, and a fair few of them are for products created with distillates or raw extracts.
But... how many, not including the three that have been adjudicated so far, do you think are for synthetic or isolated CBD?
Public Accounts Committee Oral evidence: Regulation after EU Exit, HC 32 Monday 13 June 2022
That reflects the direction novel foods for CBD products has been going since deadlines and requirements were first announced to the industry on 13/02/20
In fact, we can go further back than that, to October 2018, when the FSA submitted a secret Article 4 to the EU with an opinion, which the EU adopted in January 2019, that an MCT oil with 10% CBD isolate was novel.
Article 4 from the FSA, submitted to the EU one month before the legalisation of Epidiolex/medicinal cannabis
That Article 4 covered every format for ingestible CBD product, just as the ADI does, even though it was derived from toxicology reports for CBD isolate.
I mean, there are other aspects of novel foods for CBD products that show the FSA is working to someone's agenda
If we're talking about ethics and morals, and how the CBD industry is being beaten into submission by a regulatory authority who is supposed to ensure that there is a safe and fair market environment for all, there are numerous areas we could delve into, which of course includes the authorisation of applications for companies the FSA allowed into the CBD amnesty, despite them not qualifying for that route.
Do I need to say that the FSA is corrupted inside of novel foods for CBD products, or do I have to highlight that conflicted academics have been providing advice both on the process and for which applications are to be authorised without declaring their interests, or those associated with their employers?
Of course, you already know it's not just the Centre for Toxicity (CoT) or the ACNFP, and that there was a significant appointment in 2014, by Theresa May, of Prof. Ben Whalley to the ACMD on the creation of the Phytocannabinoid Working Group, whose final report in 2016 defined 12 controlled cannabinoids, all of which are of interest to GW.
Prof Ben Whalley, centre
I mean, we do also have a head of novel foods, who ignored actionable evidence of wrongdoing inside of that process two years ago, which led me to submit a complaint that the FSA refuses to take seriously.
We've also have food crimes, specifically substitution, where the FSA validated Pureis' products on the basis of synthetic CBD being identical to CBD isolate, two years before an act of parliament allowed for that distinction.
The FSA calls that 'compromising the authenticity of food', which they take very seriously... unless they do it themselves, in which case they will ignore anyone who points out that issue
And what about products that have been validated despite breaching MoDR's 1mg rule?
And we could also go into the hypocrisy in a process, where the FSA has removed products from the public list for either not existing on or before 13/02/20, or for breaching the 1mg rule, despite the fact that they have validated and authorised products that also breach that guidance
'Corrupt'... it's a big word that shouldn't be used unless there is absolute proof that it applies to the situation being described.
I believe I hold that proof. What's more, no one has challenged me for using that word, which says a lot.
But at the same time, who needs proof when we have the situation with the ADI, and companies not being able to adjust their labels to reflect consumer safety advice, from the FSA, in case the FSA boot them out of a process which is now over four years old.
What's more, in that time, or at least from the point that the 10mg ADI was conceived (March 2023), the FSA had another 197 or so applications with safety data that they could have used to either verify that 10mg level, or to question whether the data relied on was accurate.
After all, 16 lab reports from GW gave us a 70mg ADI from 2020 until that 10mg was announced... and I'm sure that those lab reports would have been far more comprehensive than those used by the FSA from Pureis, Cannaray, and EIHA
Before someone draws a distinction between reports for pharmaceutical products vs. those for foods, I was in fact the person who raised that issue with the FSA in the early part of 2023.
At a webinar held by the ACI, they proclaimed that their toxicology data mirrored that from GW's lab reports, to which I asked why data from the World Health Organisation (WHO) wasn't reflected, who in 2019 suggested that people could ingest up to 2,400mg of CBD a day with no ill effect.
The head of novel foods was at that webinar, and replied to the question himself.
It's because that data represented pharmaceutical products, and not foods...
Now by all accounts, the 16 lab reports have disappeared, possibly because they don't represent a food, shortly after I had publicly highlighted the absurdity of the head of novel food's reply to my question.
By 'shortly', I mean that despite the ADI announcement being made in October 2023, the opinion was formulated in March. The webinar I attended was held by the ACI at the end of January...
But all the same, for the first three years of novel foods, they not only gave the industry that 70mg ADI, they also defined toxicology report requirements for novel food applications.
Now when I say they have disappeared, the joint report from the CoT and ACNFP states that even though the original lab reports weren't obtainable, they were still considered, as well as additional information from the FDA and EMA indicating "some developmental effects were observed at high doses"
But we are talking about CBD food supplement products that are primarily sold to people over 18, so why are developmental effects a consideration?
And then, where is the 70mg data from the 16 lab reports?
That question needs to be asked when looking at the three studies used to create the 10mg ADI.
ADI's of 17mg, 12mg and 5.6mg were used to create the 10mg ADI that was announced on 12/10/23.
That 10mg ADI in itself seems to have been whittled down from 11.7mg a day, but if we're going on the basis that the 16 lab reports that led to a 70mg ADI were considered on top of the three that led to a 10mg ADI, the math doesn't sit right.
Either:
70mg plus the three lab reports leading to an ADI of 11.7, leads to an ADI of 26.15mg
or
16 lab reports suggesting a 70mg ADI plus those leading to 11.7 leads to an ADI of 60.76mg
The CoT used those lab reports in January 2020 to determine a 70mg ADI. So would it have mattered if they didn't have access to them? I mean, surely they must have had copies on record?
In the meeting that focused on those 16 lab reports, two unnamed observers from GW were present to view how their data for was being used, which I believe was publicly available at the time.
If it wasn't, though, did those observers just turn up with files that they then took back after being adjudicated?
Minutes to the CoT meeting held in January 2020
Further to that, there were also members of the faculty for Reading University, who did not declare any interests of their employers in that meeting or others when talking about CBD, even though Reading and GW had been engaged in R&D from 2007 to develop Epidiolex, and to conduct surrounding R&D.
Those same faculty members were present at the joint meetings for the CoT and ACNFP, so would they not be able to retrieve copies, if for some reason the CoT and ACNFP hadn't obtained any from those earlier meetings?
There is the suggestion that those 16 lab reports have been considered, but they haven't, even though other information associated with them that suggests 'early developmental issues at high doses', has.
So in that respect, there's always been an underlying intent with the ADI, even before it became 10mg.
But there is a problem here, specifically when it comes to the format of submitted toxicology data.
Cannaray started with a medicinal arm and can be seen contributing to medical studies. Pureis also has the same issues.
So when we look back at the head of novel food's comment in regards to pharmaceutical data being applied to food products, I feel that this is still the case, even though GW's lab reports have 'disappeared'.
So, it's time for me to ask you two questions that for me are the most important in light of he situation as outlined above
1 - What is the point of the ADI?
That looks like a flippant question, but that's far from the case.
Before the WHO made recommendations in 2018, the MHRA had set an ADI of 200mg. That was based on the perception of anyone taking more doing so for medicinal need, and not nutritional need.
That should give you an indicator of the point of the ADI. It's not about consumer safety, because if it was, the ADI would be defined by 200 or so lab reports as well as any publicly available information that might be relevant.
Moreover, if the ADI was about consumer safety, the academics inside of key regulatory panels would be a little more open about their conflicts, and the CoT/FSA would identify the two unnamed observers at the meeting that discussed GW's 16 lab reports and how they were to be used to affect an industry that creates products very similar to Epidiolex.
And most importantly, if there was nothing untoward in regards to the 10mg ADI, the FSA would be a little more engaging with industry stakeholders, and the industry as a whole, when announcing something that would have such a massive impact on consumers and businesses alike.
With that in mind, I believe that the ADI is about ensuring the biggest window to medicinal access, whilst leaving crumbs at the foot of the table for the inner circle, who're prepared to accept that 10mg ADI regardless of what their toxicology data says to remain in the industry.
2 - Regardless of the intent, is it right that the FSA stops, or targets companies for changing their labels to reflect consumer information that they themselves have issued?
Whether the ADI is advisory or not, it's consumer safety information... but then, novel foods isn't about consumer safety, it's about control.
Ethics
A lot of people have followed my journey over the last two years, and how I've highlighted and proven how broken novel foods for CBD products is.
But then, is it truly broken?
Yes and no, it is for the vast majority of companies, but it's not for those who have the inside rail, and the FSA will do what it must to ensure the rail huggers cross the finishing line, even if they didn't start in the blocks like everyone else.
That 10mg ADI, though. You have to see it for what it is, as I've explained it above, and then ask yourself one last time. What is the point of it?
That's why everyone needs to come together to challenge the FSA's handling of novel foods, especially when you read Part 3 of this article series, which will be released in the next couple of days, and asks another interesting question.
How can the FSA be happy with a novel foods application that the ACNFP are not happy with?
For more information on The Hemp Hound Agency, including services, and membership, or how to help support the fight for a fair industry, email cefyn.jones@hemphound.co.uk
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