Angry CBD regulators have slammed Europe’s largest trade body in a feisty retort over the thorny Novel Food issue.
In a response to questions posed by CBD Testers the Food Standards Agency (FSA) strongly countered claims made by the Cannabis Trades Association (CTA) over its approach to the U.K. CBD market.
The FSA’s uncharacteristically muscular rebuttal follows a CTA press release summarising events at a meeting between the two parties concerning European Novel Food authorisation, in November, last year.
The CTA’s statement can be found here:https://britishcannabis.org/cannabis-trades-association-gains-clarity-from-fsa-on-novel-status-of-cbd-products/
The FSA has told CBD Testers it finds this summary a ‘misrepresentation’, ‘disappointing’ and ‘inaccurate’. With the U.K. and European CBD industry currently in a regulatory limbo the CTA & FSA spat will not go un-noticed.
A Brief Novel Food Summary
Over the last few years the rapidly-growing British CBD industry has developed a self-regulatory framework which, in the main, has been led by the CTA. 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 E.C. 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 28 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, they are pursuing an Article 4 submission with the EC which they hope will secure recognition of this historical data and determine that CBD plant extracts – but not isolates – are not new, or Novel.
FSA Responses to 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.
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. 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.
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.
An article 4 request will not alter any enforcement position and offers no further protection against enforcement.
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, 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 as part of our ongoing considerations of CBD safety. This is not specifically part of the application process, and any such safety information should also be included in an application for authorisation.
And, Finally ‘Incorrect’ ‘Misinterpreted’ and ‘Disappointing’
A spokesperson for the FSA provided this additional information to CBD Testers: “For clarification, CTA shared a draft of this news story with us in December.
“We made it clear to them via email before publication that their interpretation of our discussion in November 2019 was incorrect. We addressed each of their points and explained clearly how they had misinterpreted what was said at the meeting.
‘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.”
EU Novel Food and The Legal Status of CBD Oil
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 aired 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 Food, 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.”
We will be gauging the CBD industry’s re-action to these latest developments and will be publishing these views over the coming week.
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