IF YOU ARE A BRAND WHO FUNDED APPLICATION RP 427, THEN DEPENDING UPON YOUR PRODUCT TYPES AND THEIR STRENGTHS, THE OUTCOMES OF THE SAFETY ASSESSMENT MIGHT BE “SWEET”, “BITTERSWEET” OR JUST DOWNRIGHT “BITTER”

The UK FSA has recommended certain products from two CBD Brands for Authorisation under the Novel Foods approval process - but only at a level of 10 mg per day rather than the 50+ mg per day for which it is forcefully contended that there is evidence of safety.

THE PRACTICAL CONSEQUENCES OF THE CHANGE OF THE HOME OFFICE’S POLICY ON CONTROLLED CANNABINOIDS CONTENT IN CBD PRODUCTS

A SURPRISING ABOUT-TURN IN HOME OFFICE POLICY IN RESPECT OF “EXEMPT PRODUCTS” UNDER THE MISUSE OF DRUGS REGULATIONS

For the past 4 years, DevelRx and The Canna Consultants have worked in collaboration with the goal of achieving an objective and scientifically valid assessment the safety risks posed by the introduction of CBD as a novel food or food supplement.

THE FSA’s STANCE ON THE PUBLIC LIST FOLLOWING THEIR ADVICE TO LIMIT CBD INGESTION TO 10mg PER DAY – A CONTRADICTION IN TERMS

ADVICE REGARDING THE FSA’s REDUCTION IN THE RECOMMENDED DAILY INTAKE OF CBD FOLLOWING A MEETING WITH THEM HELD TODAY

THE WHOLE OF THE UK CBD INDUSTRY SUFFERS THE COLLATERAL DAMAGE CAUSED BY ONE CONSORTIUM’S POORLY DESIGNED STUDY

RESPONSE TO THE ATTACK ON OUR INTEGRITY BY THE ASSOCIATION FOR THE CANNABINOID INDUSTRY

The revocation of Jersey Hemp's cultivation, extraction and export licences by the Government of Jersey (at the behest of the UK Government) is unfortunate for all those involved in the business, but it is no surprise – it was inevitable.

This week alerted the wider CBD market to some old issues which we had been repeatedly raising with participants who were either already subscribed to the EIHA application or were the recipients of invitations to join the application, plus a considerable new issue around the EIHA Toxicology Consortium results.

For many, many months now we at The Canna Consultants have we have repeatedly informed market participants that those who had subscribed to the EIHA Toxicology Consortium were going to get a Rude Awakening...

Recreational drug use has been categorised as immoral, evil and a fundamental characteristic of weakness by both the press and many social commentators over the past 50 years. This has provided the continued justification for punitive enforcement and the “Outraged from…” style of journalism which...

Over the last few months we have read with increasing frequency posts and publications by the Secretariat to the APPG, the Advisory Board to the Secretariat (SAB APPG) and by the members to the Secretariat Advisory Board. Interestingly we have neither heard nor read anything by the actual All Party Parliamentary Group on CBD Products (APPG).

Reaction to the EFSA statement on safety of cannabidiol has been mixed. Some claiming it as an opportunity, others citing calamity and the usual suspects claiming to have foreseen it – no-one foresaw this.

HEADLINES FROM EFSA’s STATEMENT ON THE “SAFETY OF CANNABIDIOL AS A NOVEL FOOD: DATA GAPS AND UNCERTAINTIES” (PUBLISHED ON 7TH JUNE 2022)

THE ADVISORY COMMITTEE ON THE MISUSE OF DRUGS CONFIRMS WHAT WE AT THE CANNA CONSULTANTS HAVE ALWAYS STATED: THERE IS CURRENTLY NO DEFINED CONTAMINANT LEVEL FOR CONTROLLED CANNABINOIDS IN CBD PRODUCTS (BUT THEY NOW RECOMMENDED ONE)

THE ADVISORY COMMITTEE ON THE MISUSE OF DRUGS CONFIRMS WHAT WE AT THE CANNA CONSULTANTS HAVE ALWAYS STATED: THERE IS CURRENTLY NO EXEMPTION FOR CBD PRODUCTS FROM THE MISUSE OF DRUGS ACT (BUT THEY NOW RECOMMENDED ONE)

THE ADVISORY COMMITTEE ON THE MISUSE OF DRUGS (ACMD) PUBLISHED ITS CONCLUSIONS INTO THE APPROPRIATE MAXIMUM CONTROLLED CANNABINOID LEVEL WITHIN CANNABIDIOL (CBD) “WELLNESS” PRODUCTS

Food Standard Agency Chief Executive's Report to the Board (8TH DECEMBER 2021).

RE: Food Standard Authority (FSA) Novel Food applications for cannabidiol; Implications for replicate toxicity testing in animals

There is a prescribed process which must be followed prior to any change in laws which relate to controlled substances in the United Kingdom.

With today’s announcement we would suggest that the FSA have significantly moved the goalposts after the start of the match. The question is, who would ever have predicted it?

Until today there were two options following the submission of a Novel Food application: Validated or Unvalidated. It now appears as though there is a third: Unvalidated, but heading in the right direction.

As we approach the deadline for submission in order to achieve the benefit of the UK Food Standard Agency’s position on Cannabidiol, the industry in Northern Ireland is dealt a body- blow which many will not be aware of.

We return briefly to a fundamental topic which we have written about before – in both 2019 and 2020: If THC is not permitted in products, to what level of precision is the product to be examined to establish the THC level?

In May we published an analysis of the Judgement of Advocate General Tanchev in respect of the Kanavape case, “Can the movement of CBD within the European Member States be prohibited it if is derived from prohibited elements of the plant?”. We observed that there was “good” and “bad” in the provisional Opinion.

The FSA refutes claims made by a prominent self-styled trade organisation that it has changed its toxicology policy.

SAFETY STANDARDS SHOULD BE DRIVEN BY THE REGULATORS AND SCIENCE, NOT BY COMMERCIAL ENTITIES OR ASSOCIATIONS. YOU MAY CHOOSE YOUR OWN PATH, BUT TO DISMISS OUR ANALYSIS MAY BE UNWISE.

We have reproduced the questions as they have been submitted in order not to interfere with them. If you are unable to answer the question as drafted, we would encourage you to answer what you feel is the import of the question in order that market participant is not disadvantaged by potentially poor language selection in their phraseology.

Is the FSA's policy that any CBD "New to Market" products will be treated differently than those "Already on the Market" justified despite there being no difference in their potential risks? Perhaps the more telling question is whether the policy will be sustained in the face of an inevitable legal challenge?

In May we published an analysis of the Judgement of Advocate General Tanchev in respect of the Kanavape case, “Can the movement of CBD within the European Member States be prohibited it if is derived from prohibited elements of the plant?”

The recent news that Mike Harlington, the now ex-Chairman of the CTA, has been ousted by the organisation’s board (now led by Tom Whettem) was reported by The Canna Consultants here. The news led us to take a delve into TrustCanna... and what did we find?

It was with interest that on the evening of 13th June 2020 we discovered (from the Business Cann website) that, what we at The Canna Consultants had thought was on the cards for many months, had actually come to pass. The headline read ““Disagreement” sees Europe’s largest trade association lose its Chairman”.

WHY SELF-REGULATION OR REGULATION THROUGH QUASI-TRADE BODIES/ASSOCIATIONS/GROUPS WILL NOT WORK. The Food Standards Authority of Ireland has published a Report identifying the CBD Regulations applicable in the Irish Republic and containing the results of their analysis of 38 products being sold on the Irish market. The analysis results found by the FSAI are very similar to those found by a similar study of UK products undertaken by the Centre for Medicinal Cannabis (CMC) and published in a report the Summer of 2019.

The race for earliest submission of a Novel Food Dossier is a false one. This is especially the case when submissions made thus far, so we understand, lack the appropriate scientific data in respect of end products for which Authorisation is being contended and, in some cases, lack any scientific data in respect of the subject of the application at all.

On 14th May 2020 the Advocate General (Tanchev) of the Court of Justice of the European Union (CJEU) delivered their Opinion on the above question. The result is both a “Yes” and a “No”: National restrictions by Member States are possible, but such restrictions as are sought to be enforced must be (a) justified and (b) no more than necessary in order to achieve the justified aim.

Recently we have seen an increase in the marketing of CBD products to professional athletes, which raises headlines in the media, and concerns with ourselves. While it may be that there are real (or perceived), benefits from CBD for professional athletes, we caution the use of products without a thorough program of due diligence. The responsibility for that due diligence cannot be abrogated by the individual and the liability for any transgression rests solely with the athlete.

Novel Food Authorisation: The Starting Point, The Principle, The Practical Effect, The Sequence. Member States of the European Union are not the only jurisdiction to operate a system which seeks to manage what novel food and novel food ingredients can be made available to their citizens, but they do operate probably the most stringent system and require the most comprehensive data submissions in order to gain successful market authorization.

Is a Novel Food authorisation required for a Brand’s end product? We previously published a document to correct mis-statements that were being made to market participants by, so-called, experts in the industry. Almost a month on from the FSA’s announcement concerning Novel Foods we continue to read the same mis-statements published by those same, so-called, experts.

The United Nations is certainly not going to be the answer to the THC “issue” in the short-term and is unlikely to be the answer in the long-term either. This month the United Nations was due to vote on proposals made to it by the World Health Organisation, one of which was: “Preparations containing predominantly cannabidiol and not more than 0.2 per cent of delta-9-tetrahydrocannabinol are not under international control”.

FSAI DEMONSTRATE THAT REGULATORY COMPLIANCE AND QUALITY CONTROL ARE NO BETTER IN IRELAND THAN THEY ARE IN ENGLAND. The Food Standards Authority of Ireland have published a Report identifying the CBD Regulations applicable in the Irish Republic and containing the results of their analysis of 38 products being sold on the Irish market.

FSAI MEAN BUSINESS CONCERNING THE REQUIREMENT FOR THC CONTENT IN CBD PRODUCTS. Previously we published a Summary of the FSAI Report into their testing of CBD products. The FSAI has not waited long to bare its teeth. Certain Brands have had some of their products removed already, including one high profile and “industry-leading” Brand which claims to be THC-free in respect of the very batches tested by the FSAI.

Following the FSA’s announcement last week on the Novel Foods position, we observed that many so-called experts were coming out of the woodwork and positing questions that, if they held the expertise that they assert, they would know the answer to.

Clarification of the FSA position statement on 13 February 2020. For those who have not been involved in the design of the structure, the FSA’s announcement took many by surprise. Quite understandably, market participants were digesting the Food Standard Agency’s morning announcement and asking themselves, and the wider industry questions about what it meant and how it would be implemented.

What are the applicable criteria for a product which contains THC to receive an exemption from the underlying criminal law? FSA permits continued sale of CBD products provided that certain conditions are met, one of which is that they “do not contain substances that fall under drugs legislation”. The Canna Consultants have always held the opinion that there is no exemption for THC content in CBD products. Read our comprehensive analysis of the law on THC content.

This document was provided to key Stakeholders in October 2019. We are pleased that the FSA has adopted the foundation structure that The Canna Consultants advocated. On 13th February 2020 the Food Standards Agency announced its intended approach to the issue of CBD and Novel Foods classification.