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.
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 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.
EU Novel Food and The Legal Status of CBD Oil
Our questions to the FSA, its responses and the CTA’s comebacks:
Key:
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.
CBD Warnings From FDA Spook Major Consumer Brands
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
Importance of Stocking GMP Products in Your Shop
5. Ps.
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.
Importance of Stocking GMP Products in Your Shop
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.”
For more articles like this one, subscribe to the CBD Business Weekly Newsletter.
An Update On British CBD and the Novel Food Regulations in EU
The post U.K. Regulator FSA And Leading Trade Group CTA Lock Horns in CBD Spat appeared first on CBD Testers.
