The Cannabis Trades Association and U.K. regulator the Food Standards Agency have crossed swords in a heated exchange over the legal status of CBD products.
In a response to questions posed by CBD Testers the FSA strongly countered claims made in a press release by the CTA. But, the CTA has hit back strongly – and CBD Testers has agreed to publish its feisty responses to the FSA’s answers.
This public row follows a CTA press release summarising events at a meeting between the two parties on European Novel Food authorisation, in November, last year.
The CTA’s press release can be found here: https://britishcannabis.org/cannabis-trades-association-gains-clarity-from-fsa-on-novel-status-of-cbd-products/
The FSA told CBD Testers it finds this summary a ‘misrepresentation’, ‘disappointing’ and ‘inaccurate’. However, the CTA has hit back at the FSA with a series of counter-claims – detailed below.
As a result of last January’s European Commission Novel Food directive the European CBD market continues to exist in a haunting regulatory limbo. While the exchanges between the FSA and the CTA will do little to move the issue forward, they are an indication temperatures are rising on all sides.
The novel food debate is complicated…
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A Brief Novel Food Summary
The CTA is by far the largest world-wide CBD trade organisation with around 1,000 member businesses in around 30 countries. However, a regulatory hand grenade was lobbed at the European CBD industry when the European Commission (E.C.) designated CBD a Novel Food, in January 2019.
New – or Novel – food products have to undergo pre-market safety tests and secure approval from the EC before they can be sold; a process which can take up to five years and cost up to £500,000.
One massive issue for the CBD industry, here, is that once a submission has been made then a product must be removed from sale until approval is secured – effectively, a terminal event for most.
The Novel Food Catalogue has no legal weight but sets an enforcement benchmark for authorities in the 29 member states. In practice there has been little enforcement in both the U.K, and the rest of Europe, and the CTA and other European trade groups are fighting back.
They argue that CBD has been around in a plant extract form for hundreds of years and have provided evidence to that effect. And, it is pursuing an Article 4 submission with the EC which it hopes will secure recognition of this historical data and determine that CBD plant extracts – but not isolates – are not new, or Novel.
Our questions to the FSA, its responses and the CTA’s comebacks:
- CBD Testers
1. Has the FSA acknowledged the legitimacy of the Article 4 challenge on Novel Food and agreed to allow CTA members to continue to make and sell CBD products, unfettered by enforcement action, while this progresses?
FSA: To date the FSA has not received an Article 4 submission from the CTA, although these may be made to any relevant Member State within the EU. An article 4 submission is something that any business or relevant party may do where they are not certain if a food is novel or not and should always be submitted before placing any foods on the market.
As such the submission of an
Article 4 does not in any way remove responsibility to comply with novel foods
legislation, and no agreement has been made with the CTA (or any other
organisation/business) in relation to enforcement actions.
CBD extracts have been confirmed as novel foods, and any potential submission of an Article 4 request does not alter this position, nor enforcement options available.
CTA: The CTA has never stated that the FSA agreed to allow CTA members to unconditionally continue to make and sell CBD products, only that it agreed that following an article 4 determination that they are not novel they would be completely isolated and protected from enforcement.
They (FSA) agreed that following an article 4 determination that they are not novel they would becompletely isolated and protected from enforcement, the CTA is NOT making a submission in the UK and as such considers the UK FSA to be the least important of the players in the moment given the requirements of Article 50.
2. Is it right to say there will be no ‘grace period’ for firms making Novel Food application, so in effect they will not be able to make and sell CBD products for sale in the UK while these applications are processed and considered by the EC?
FSA: CBD extracts were confirmed as novel foods in January 2019.
CTA: Incorrect in Jan 2019 the catalogue that is not legally binding and only serves as orientation, was changed for the third time. This forms no confirmation of if CBD extracts are novel or not. It’s merely an opinion that is in no way a legal determination. Our QC has repeatedly stated that “ The approach to the Novel Foods decision is massively inconsistent throughout the EU. In the Czech Republic no one cares: Cannabis is entrenched in the food chain. In Germany the approach is strict but their Courts have decided that the Commission’s Novel Food Catalogue constitutes merely an indication that may be rebutted. This is really a political issue, with vested interests in the background. Is the FSA bluffing? In my view, the critical factor on enforcement will be political, not legal, and the budget for enforcement will be also be a vital factor.
FSA: As no relevant products have so far gained authorisation, all CBD extracts being sold as food or food supplements are doing so in contravention of the novel foods legislation.
CTA: This statement is false, the novel status of CBD extracts has never been tested in law and extracts would only be in contravention of the novel foods legislation if a legally binding determination was made.
FSA: This position is the same, whether or not any application for authorisation has been made. All novel foods should gain the appropriate authorisation before being sold or marketed, and this means all CBD extracts are subject to potential enforcement action irrespective of if they have made an application or not.
CTA: This also means all CBD extracts (including isolates) could be protected from enforcement.
FSA: An article 4 request will not alter any enforcement position and offers no further protection against enforcement.
CTA: Yet an Article 4 determination would offer protection against enforcement when the determination is made that CBD extracts are not novel.
3. Has the FSA concluded ‘CBD does not produce adverse effects and consequently there will be on enforcement action’.
FSA: We are continuing to monitor food safety aspects of CBD. The information available on CBD does not suggest any significant safety concerns related to CBD,
CTA: This is very important, why would any enforcement action take place, when there is no public safety concern. Enforcement action would be a waste of taxpayers money, providing no protection to public health, which would result in real issues of public health not being addressed and the action placing the public in danger
FSA: But as part of the novel foods authorisation process they do need to be evaluated for safety. If we find evidence to say that CBD extracts in general, or specific products containing CBD, risk harm to the public, they will be removed from sale.
4. And finally is it waiting for a further submission from the CTA. As the statement concludes: The CTA…(will be) submitting data around the safety of CBD to be assessed at the next toxicology meeting in a few weeks’ time. Based on data that calls into question the reliability of their supportive evidence, this could result in there being no safety concerns around cannabis extracts and all enforcement action being cancelled moving forwards.
FSA: The CTA has told us that they intend to send us data on the safety of CBD, but so far no information has been received. We will review any information we’re sent
FSA: For clarification, CTA shared a draft of this news story with us in December.
CTA: This is incorrect we shared it with them in November and they failed to respond until the week before Christmas
FSA: We made it clear to them via email before publication that their interpretation of our discussion in November 2019 was incorrect.
CTA: This is completely false, they only informed the CTA that they would not endorse and support the CTA statement, at no point in the response did they make any claims that our statement was incorrect. We do not expect any regulatory department to endorse a statement that is made by any trade body. The FSA to this date, has not claimed any of our statements are not factually correct. It would be impossible for them to do so given there were 7 people in the meeting including a legal representative that witnessed the responses the FSA made.
FSA: We addressed each of their points and explained clearly how they had misinterpreted what was said at the meeting.
CTA: This is a false statement, they did not address each of the points or did they say we had misinterpreted what was said at the meeting. Just provided some generic information which they thought we may find helpful.
FSA: We have written to the CTA expressing our disappointment at their conduct and urged them to correct the article to avoid misleading their members and disadvantaging them in working towards compliance for their products.
CTA: We have responded to the FSA and are in discussions with our legal team with regards the false, misleading and damaging claims now being made by the FSA with regards the CTA. We are working closely with our assembled legal team and as such we are writing to the FSA separately to ensure that they cannot write letters to us that significantly change their position given that there was legal representation on behalf of the CTA in the room at the time. We have refused to amend or remove our press release believing it to be a complete and correct response to the meeting and subsequent conversations we had at the time.
FSA: CBD is ‘Safe’
This spat will once more provoke uncertainty amongst Europe’s booming CBD industry but there are some rays of hope in the FSA’s answer to the questions posed by CBD Testers.
As for the first time, the FSA has slid towards the widespread industry view over the safety of CBD products.
In its response to CBD Testers, the FSA says: “We are continuing to monitor food safety aspects of CBD. The information available on CBD does not suggest any significant safety concerns related to CBD…”
While the FSA say it will look to enforce the Novel Food regulations this newly-stated position on the safety of CBD is unlikely to lead to any concerted enforcement action in the U.K.
FSA’s Current Position
For many months the FSA has maintained the following public-facing position on Novel Foods, and it has re-stated this as its current position to CBD Testers:
“CBD extracts are considered novel foods under food law and we expect companies to comply with the novel foods process, which includes submitting safety information about their products.
“The FSA is considering the best way to ensure CBD food-related products currently on the market move towards compliance. We will be providing an update on this process and our position when we have completed those considerations.”
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