Escalation - a preview of The Hemp Hound Agency's meeting with the FSA to discuss the Public Interest Disclosure Complaint against their handling of novel foods for CBD products

In July 2022, I submitted a Public Interest Disclosure Complaint against the FSA's handling of novel foods. The reasons for that complaint were:

• Products have been validated despite not being available to the consumer on or before 13/02/20.
  

• The FSA are selectively enforcing MoDR, or as it was defined after the original complaint response, the 1mg THC threshold per product, regardless of size.
  

• The FSA by not observing the rules they set out above is creating a Cartel (Monopolies) Market, and allowing GW to influence the novel food process with 16 lab reports for CBD isolate and academics who failed to declare the interests of their employers.
  

• The head of novel foods twice dismissed evidence to show that certain validated products weren't available to the consumer on or before 13/02/20, despite him confirming that this was a pre-requisite for qualifying for the CBD amnesty, and the public list for CBD products.
  

• The FSA has potentially committed food crimes by diminishing, or compromising the authenticity of supplemental CBD products.
  

• Let's just say, the last point is related to the ACI.

The full complaint can be found here:

Public Interest Disclosure, CJ to the FSA.pdf

Download PDF • 8.65MB

The FSA's response to that complaint can be found here:

20230512 Hemphound Agency NS to CJ complaint response (3).pdf

Download PDF • 262KB

The response was received in May 2023, and it dismissed every point raised. However, the response itself suggests two things:

• The FSA are trying to deflect my complaint, especially by confusing 'on sale' on 13/02/20 with 'new-to-market', and by confusing those with very high THC levels in their validated products as being part of credible applications, whilst they selectively enforce guidance on 13/02/20 and the 1mg rule/threshold on others.
  

• If there was an investigation into my complaint, the evidence I supplied was either ignored, or disregarded completely.
  

Below you will find PDF's for each section of my complaint escalation response, with a brief summary attached.

13/02/20: In this section, I discuss events on 13/02/20, and the complaint highlights apprehensions about the FSA's handling of CBD novel foods regulations.

I question the consistency in applying rules and guidance, particularly the distinction between "on sale" and "on-the-market", and question the potential for discrimination against the majority of businesses who have obliged guidance from the FSA.

I inquire into changes in requirements, the legitimacy of products and companies on 13/02/20, and the FSA's instructions to Trading Standards.

A further concern revolves around whether any potential wrongdoing by the FSA would be addressed, and who would be held accountable.

13-02-20.pdf

Download PDF • 1.48MB

MoDR / 1mg rule: This part of the complaint addresses the FSA's handling of validated CBD products potentially violating the Misuse of Drugs Regulations 2001 Regulation 2 Limb C, aka the 1mg rule.

It questions the FSA's 1mg threshold, seemingly introduced after I received a response to my complaint, and selective enforcement by citing cases like Moonrise CBD, and providing case studies of companies breaching the 1mg threshold. I also ask a very important question on whether the FSA's 1mg threshold is in fact MoDR in disguise.

I also raise concerns about the FSA's dismissal of evidence and a perceived lack of fairness, and ask for clarity on the removal of non-compliant products, potential judicial reviews, and for confirmation of a comprehensive review of submitted evidence.

1mg rule.pdf

Download PDF • 433KB

Monopolies Market: This section of the complaint challenges the FSA's handling of conflicts of interest within the Committee on Toxicology (COT) regarding CBD products and the formulation of guidance.

I highlight the relationship between Reading University, its researchers, and GW Pharmaceuticals, and questions whether there was a failure to disclose interests during discussions on CBD novel foods.

The complaint questions whether academics affiliated with Reading University should have declared their institution's interest. It also asks whether selective enforcement of MoDR or a 1mg threshold, and whether a product was on sale on 13/02/20 or on-the-market at that time, is leading to the creation of a Cartel (Monopolies) market, and potentially, a judicial review.

The section concludes with specific questions about recognizing university interests, connections between GW Pharmaceuticals and Reading University, disclosure requirements for academics, the creation of a cartel market, and the identification of unnamed GW Pharmaceuticals observers at a COT meeting to discuss novel foods and GW's 16 lab reports.

Monopolies.pdf

Download PDF • 199KB

Food Crimes: This section of the complaint addresses concerns related to labelling language and the FSA's handling of white labelling in the CBD novel foods market.

It questions whether the FSA's language on the public list creates a fair playing field and highlights potential issues with the authenticity of food, particularly in the context of synthetic CBD products.

I also point out discrepancies in the application of labelling requirements and challenges the FSA's introduction of a 10mg ADI for CBD products, derived from studies on synthetic CBD and CBD isolate.

The complaint also questions the FSA's focus on the product rather than the ingredient in novel foods for CBD and requests clarification on the interpretation of regulations.

Food Cimes.pdf

Download PDF • 111KB

The contribution by a named manager at the FSA: This part of the complaint addresses the conduct of a named FSA manager, primarily the head of novel foods, focusing on communication between March and July 2022.

The response asserts that all interactions were factual, impartial, respectful, and clear, meeting the Civil Service Code's expectations. However, discrepancies arise concerning impartiality and discrimination against companies.

Evidence was presented regarding products inaccurately validated, with the head of novel foods dismissing it. The response emphasizes his honesty, respectfulness, and clarity, yet fails to address concerns about honesty, objectivity and integrity.

Questions are raised about changes in policies and potential discrimination within the industry. The complaint further highlights the necessity for an authentic evaluation of the manager's actions in alignment with the Civil Service Code.

The contribution by a named manager at the FSA.pdf

Download PDF • 165KB

ACI webinar in January 2023: “What the world can learn from the UK approach to CBD regulation”: This additional part of the complaint involves an ACI webinar, questioning if it signalled problems in CBD validation.

I delve into concerns about ACI's use of Epidiolex data and note potential contradictions. I bring up the authenticity of CBD as food, the FSA's connections with ACI, and links between GW, ACI, and Deloitte.

I also inquire about FSA-ACI meetings, and suspecting undisclosed interactions.

Now for a personal message from The Hemp Hound Agency

Two years... that's how long I've been fighting for fairness within novel foods for CBD products.

It's been a long road, as the files above and the output I've maintained over that time will confirm.

But what have I got out of it?

• Some have been hesitant to join The Hemp Hound Agency, even though for the best part, it's The Hemp Hound Agency that has been championing for a level playing field, and appropriate updates on industry guidance when it's required.
  

• Others have expressed fear that by endorsing the actions and direction of The Hemp Hound Agency, the FSA might target them through their novel foods application.

In essence, I've done myself no favours in fighting for the hemp and CBD industry.

But at the same time, I have. The amount of calls I've had from companies who thank me for what I've been doing is insane.

I know I'm fighting the right fight, and for an industry that I love, and have called home for the best part of 9 years now. That fight means nothing if I can't get support though, which is why this document is behind a pay wall for 30 days. If you paid for access, thank you. You're helping me do what the trade associations should be doing.

If you have waited 30 days for free access, that's great, but do me a favour, please share this document to where ever you can. The more who are aware of this fight, the better. Most importantly, the more who are aware of this fight, the more the FSA and the British Government in general will take note.

For more information on The Hemp Hound Agency, email cefyn.jones@hemphound.co.uk, or call 07456528813