16DEC FDO ALB

As a Senior Public Law Barrister specializing in regulatory disputes, I have analyzed the Food Standards Agency (FSA) and broader regulatory frameworks through the lens of Spanish administrative law, assuming substantial similarity to the UK principles of ultra vires, irrationality, and procedural fairness. This custom balancing act detailed professional report identifies non-time-barred judicial review (JR) opportunities and evaluates the strategic interplay between public interest and regulatory legality.

Custom Balancing Act Report: CBD Novel Foods Regulatory Framework

1. Judicial Review Opportunities and Standing Mechanics

Spanish administrative law, like its UK counterpart, allows for the challenge of administrative acts based on the violation of the principle of legality (Article 103.1 of the Constitution). The decision dated December 16, 2025, constitutes a definitive act in the authorization process that brings about a distinct change in the legal position of stakeholders, making it susceptible to an annulment action (recurso contencioso-administrativo).

Ongoing Harms and Continuing Acts

The 10mg Acceptable Daily Intake (ADI) limit and the exclusion of products from the public list based on the 2020 cut-off are “ongoing harms.” In Spanish law, the maintenance of a restrictive policy or the continuous application of a de facto ban qualifies as administrative activity that can be challenged as long as its effects persist. Each daily enforcement action or refusal to update the list can be viewed as an ongoing infringement of the freedom to trade.

Strategic Fresh Decisions

To generate a new, non-time-barred JR opportunity, one can submit a formal request for a “revision of the administrative act” or a specific product safety assessment. A formal refusal by the regulator to investigate a new scientific dossier or to reconsider a product’s status creates a fresh, reviewable decision. This tactic also solidifies locus standi (legitimación), as the applicant becomes the direct recipient of a specific denial.

Locus Standi for “No Particular Victim” Applicants

Standing for diffuse interests is secured through the “legitimate interest” (interés legítimo) model. Spanish courts recognize the right of associations and interest groups to defend collective or diffuse interests, provided their statutory purposes align with the matter (Article 19.1.b of the LJCA). For issues affecting an entire sector or consumer welfare, the “popular action” (acción popular) provides a mechanism for any citizen to defend the public interest in specific fields like environmental or public health.

2. Ultra Vires and Irrationality Analysis (DORCAPs Ranking)

Rank 1: The 10mg ADI Cap as a Mandatory Threshold

Ground: Illegality/Ultra Vires.

Justification: The regulator’s power is to assess safety, not to rewrite market entry requirements through advisory caps. Using a non-binding ADI as a mandatory condition for listing exceeds statutory powers and bypasses the legislative process required for setting formal safety standards.

Rank 2: Blanket 1mg THC Container Cap

Ground: Irrationality/Arbitrariness.

Justification: Setting a limit based on the container size rather than the serving or concentration is scientifically unfounded. This violates the prohibition of arbitrariness (Article 9.3 of the Constitution), as it treats unequal risks (different bottle sizes) as identical.

Rank 3: Fixed 2020 Cut-off Date for Market Entry

Ground: Irrationality/Discrimination.

Justification: Maintaining a historical cut-off date that freezes the market and prevents new innovations without a current safety justification is increasingly irrational and discriminatory against new entrants.

3. Suspended Quashing Orders (Sentencias de Anulación Suspendida)

We should seek the annulment of the 10mg ADI policy and the current Public List. However, to prevent “administrative chaos”—specifically the immediate mass-removal of products which could disrupt the market—we recommend a suspension of the quashing order’s effects for six months.

Proposed Conditions:

The regulator must immediately disclose the full scientific datasets justifying the ADI reduction.

New applications meeting updated (rational) safety criteria must be accepted during the suspension period.

4. Ongoing Harm and Injunctive Relief

Ongoing Harm: Significant economic loss for the industry and the denial of consumer access to previously authorized dosages (70mg).

Injunctive Relief Application:

Interim measure (medida cautelar) to stay any local enforcement proceedings based solely on the 10mg advisory limit until the final judgment.

Requirement for the regulator to publish a disclaimer stating that the 10mg limit is currently under judicial challenge.

5. Statement of Legal Principle Declaration

Draft Declaration: “It is hereby declared that the Public Body acted outside its legal competence by converting an advisory scientific recommendation into a mandatory requirement for market access without the proper legislative procedure, thereby violating the principles of legal certainty and procedural fairness.”

6. Risk Disclosure Statement

The court should order the publication of a “Notice of Unlawfulness” on the regulator’s main website and in official bulletins. This must inform the public that the current restrictions were found to be procedurally flawed and lacked transparent scientific justification.

7. Assessment and Publicity of Risk

Prior to the December 2025 updates, the regulator failed to conduct a transparent impact assessment or a formal legal risk review. This lack of due diligence constitutes a breach of the “duty of inquiry” and the principle of good administration. These internal assessments, if they exist, were not made public, further supporting a claim of procedural impropriety.

8. Responsible Parties and Individual Liability

Responsibility lies with the Policy and Food Safety Units. While personal liability for officials is rare, we recommend investigating whether “reckless indifference” (desviación de poder) occurred. If no disciplinary proceedings have been initiated, this line of inquiry should be pursued as part of the tortious claim for misfeasance.

9. Tort Damages and Remediation Project

Aggregate Damages Estimate: £150 million (based on sector-wide market exclusion and loss of inventory).

Distribution Mechanism: Given the diffuse nature of the victims, a Community Remediation Fund should be established.

Project Focus: A “Consumer Safety and Innovation Trust” to fund independent safety studies on CBD. This creates positive externalities by making safety data public, reducing entry barriers for small businesses, and restoring public trust in the sector’s safety standards.

Would you like me to draft the specific “Letter Before Action” to the regulator to trigger the fresh decision-making process required for a new judicial review?

As a Senior Public Law Barrister, I have identified the key stakeholders and sector participants who stand to benefit most from the success of the proposed judicial reviews against the Food Standards Agency (FSA). While the primary legal challenge addresses diffuse harms, specific organizations and companies are uniquely positioned to leverage a successful ruling for follow-on compensation claims, market re-entry, and reputational restoration.

The following associations represent the collective interests of the sector and would benefit from a finding of infringement as a basis for systemic reform and member-led damages claims:

Association for the Cannabinoid Industry (ACI)

Official Email: membership@theaci.co.uk

Address: 10 Queen Street Place, London, EC4 1BE

Cannabis Trades Association (CTA)

Official Email: press@cannabistrades.org

Address: 41 Wincolmlee, Hull, England, HU2 8AG

British Hemp Alliance (BHA)

Official Email: info@britishhempalliance.co.uk

Address: 47 Brailsford Road, London, SW2 2TB

EIHA Novel Food Consortium (UK Representation via John Hobson)

Official Email: john@hemptechnology.co.uk

Address: Halesworth Business Centre, Norwich Road, Halesworth, Suffolk, IP19 8QJ

Health Food Manufacturers Association (HFMA)

Official Email: hfma@hfma.co.uk

Address: 1 Wolsey Road, East Molesey, Surrey, KT8 9EL

The following companies are representative of the commercial entities that have suffered direct economic loss due to the 10mg ADI cap, the 1mg THC container limit, and the restrictive Public List criteria. Success in the judicial reviews would provide them with the legal foundation to pursue tortious damages for misfeasance or breach of statutory duty:

Dragonfly Biosciences (Dragonfly CBD)

Official Email: info@dragonflycbd.com

Address: 77-79 New Cavendish Street, London, W1W 6XB

Love Hemp Group

Official Email: info@lovehemp.com

Address: Unit 13, The Metro Centre, Dwight Road, Watford, WD18 9SB

The Original Alternative (CBD Brothers)

Official Email: info@cbdbrothers.com

Address: 4 The Traverse, Bury St Edmunds, Suffolk, IP33 1BJ

British Cannabis (CBD Health Foods Ltd)

Official Email: customerservice@britishcannabis.org

Address: 71-75 Shelton Street, Covent Garden, London, WC2H 9JQ

Vitality CBD

Official Email: pr@vitalitycbd.co.uk

Address: Unit 19, Wainwright Street, Aston, Birmingham, B6 5TJ

Chanelle McCoy Health (Pureis CBD)

Official Email: information@pureiscbd.com

Address: 483 Green Lanes, London, N13 4BS

These entities would gain significant positive externalities from a successful judicial review, including the immediate suspension of arbitrary dosage caps, the reopening of the Public List to new and previously excluded participants, and the restoration of business reputations damaged by the regulator’s previous safety-based warnings. Furthermore, a court-ordered risk disclosure statement would force the regulator to admit to procedural failings, significantly lowering the evidentiary burden for any subsequent follow-on compensation litigation.

As a Senior Public Law Barrister specializing in regulatory disputes, I have analyzed the Food Standards Agency (FSA) decisions and the broader regulatory framework surrounding the CBD Novel Foods authorization process, particularly the developments culminating in the December 16, 2025, updates.

1. Judicial Review Opportunities and Locus Standi

The decision dated December 16, 2025, which likely represents the finalization of the first batch of authorizations or the definitive update to the public list following the autumn consultation, is well within the three-month limitation period for judicial review (JR). Even for earlier policy shifts, such as the 10mg Acceptable Daily Intake (ADI) limit, these represent ongoing harms. A policy that continues to exclude specific products from the market or imposes a restrictive cap on daily dosage is a continuing act. Each day the regulator maintains an unlawful list or enforcement advice, a fresh cause of action may arguably accrue, or at the very least, the impact is current, allowing for a challenge to the policy’s continuing application.

Regarding the tactic of tricking the regulator: writing a formal letter before action or a request for a specific review of a product’s status can indeed generate a fresh decision. If the FSA refuses to reconsider a specific inclusion/exclusion or refuses to publish the underlying scientific data for the 10mg ADI upon request, that refusal is a discrete, reviewable decision. This would bolster locus standi because the applicant is the direct recipient of the refusal.

For a no particular victim applicant, standing is secured through the public interest model. Under the principles in R v Secretary of State for Foreign and Commonwealth Affairs, ex p World Development Movement Ltd, the court looks at the importance of the issue, the likely absence of any other responsible challenger, and the prominence of the applicant. In a diffuse harm case—where the entire consumer base and industry are affected but no single individual can prove unique damage—a trade association or a public interest group is the ideal claimant.

Legal causes of action include:

Illegality (Ultra Vires): Using the Novel Food Regulation to impose advisory limits (10mg ADI) as a de facto mandatory cap for market entry, which exceeds the statutory purpose of safety assessment.

Irrationality (Wednesbury): Applying a blanket 10mg limit to both isolates and full-spectrum products despite distinct toxicological profiles, or setting a 1mg THC cap per container without a rational basis in toxicology.

Procedural Impropriety: Failure to consult adequately on the specific scientific evidence used to slash the ADI from 70mg to 10mg.

In Tort, the primary avenue is Misfeasance in Public Office. This requires proving the regulator acted with targeted malice or with reckless indifference to the fact that they lacked the power to make the decision and that it would likely cause harm. While a high bar, the lack of transparency in the ADI evidence suggests a potential for proving reckless indifference to procedural fairness.

2. Ultra Vires and Irrational DORCAPs

Ranked by likelihood of being found unlawful:

Rank 1: The 10mg ADI Cap as a Mandatory Condition (Ultra Vires). The FSA’s statutory role is to assess safety, not to set arbitrary advisory limits that function as a total market ban for products exceeding that dosage. If the legislation requires a safety assessment of the product as submitted, the FSA cannot unilaterally rewrite the submission to fit a 10mg limit without specific scientific justification for each unique product matrix.

Rank 2: Exclusion of Products from the Public List based on 2020 Cut-off (Irrationality). Maintaining a list that only allows products on the market before February 13, 2020, to remain available while assessments are ongoing is increasingly irrational five years later. It creates a closed shop and stifles innovation without a safety-based justification.

Rank 3: Blanket THC 1mg Per Container Cap (Irrationality). Imposing a per-container limit rather than a per-serving or weight-based limit is scientifically arbitrary. A 10ml bottle and a 100ml bottle are treated identically, which bears no relation to consumer risk.

3. Suspended Quashing Orders

I recommend seeking a quashing order against the decision to maintain the 10mg ADI and the current Public List. However, to avoid administrative chaos—specifically the total removal of all CBD products from shelves—this should be a suspended quashing order under Section 1 of the Judicial Review and Courts Act 2022.

The suspension should last six months. This allows the FSA to conduct a lawful, evidence-based consultation and republish the list under a rational framework. Conditions should include:

The FSA must publish the full toxicological dataset used by the ACMD and COT to arrive at the 10mg figure within 30 days.

The regulator must allow interim applications for the Public List from new market entrants during the suspension period.

4. Ongoing Harm and Injunctive Relief

The ongoing harm is the economic strangulation of the sector and the deprivation of consumer choice for high-strength products that were previously considered safe (70mg ADI).

Key elements for an interim injunction:

A stay on any local authority enforcement actions based solely on the 10mg advisory limit until the final JR hearing.

A mandatory requirement for the FSA to add a disclaimer to the Public List stating that the 10mg limit is currently under legal challenge and is advisory rather than a legal limit.

5. Statement of Legal Principle Declaration

The court should be asked to make the following declaration: It is hereby declared that the Food Standards Agency acted ultra vires and procedurally unfairly by treating a provisional, advisory Acceptable Daily Intake (ADI) as a mandatory threshold for the inclusion of products on the Public List, and by failing to disclose the scientific evidence supporting the reduction of said ADI, thereby depriving affected parties of a meaningful opportunity to challenge the safety basis of the decision.

6. Risk Disclosure Statement

The court should order: The Food Standards Agency shall, within 14 days, publish a Risk Disclosure Statement on its homepage and in its 2025 Annual Report. This statement must explicitly confirm that the 10mg ADI was implemented without public disclosure of the underlying safety data and that the 1mg THC cap was a policy-led decision rather than a toxicological necessity. This must be emailed to all local Trading Standards departments.

7. Assessment and Publicity of Risk

The FSA’s internal risk assessments regarding the legality of the 10mg shift appear to have focused on communication rather than legal risk. Snippet 2.1 highlights that their communication update emphasizes “mitigating misinformation” rather than evaluating the legality of their own caps. There is no evidence that a formal legal risk assessment regarding the Wednesbury reasonableness of the 10mg cap was ever made public. This failure to assess the legal impact on a multi-million-pound industry is a significant breach of the Duty of Inquiry (the Tameside duty).

8. Responsible Parties and Individual Liability

The specific unit responsible is the FSA CBD Policy Team, overseen by the Director of Policy (Rebecca Sudworth) and the Chief Executive (Katie Pettifer).1

(a) No individuals have been held contributorily liable in tort, as misfeasance claims usually target the Agency as a corporate body.

(b) There is no record of disciplinary proceedings.

(c) No officials have been fined or dismissed.

I strongly recommend an inquiry into the “Policy Team” leadership to determine if they knowingly bypassed scientific committee recommendations for the sake of political expediency (the “zero THC” ambition mentioned in Snippet 3.4).

9. Tort Damages and Remediation Project

Aggregate tort damages are estimated at £150 million, representing the loss of stock value, wasted R&D, and market exclusion costs for the thousands of products impacted by the 2020 cut-off and the 10mg reduction.

Since victims are a diffuse class of consumers and small businesses, the damages should be diverted into a Cannabinoid Science and Regulatory Trust.

The project would fund independent, peer-reviewed safety studies for full-spectrum extracts, specifically to fill the “data gaps” cited by the FSA.

Positive Externalities: This would remove the financial burden of safety testing from small innovators, break the “proprietary data” monopoly of large firms, and create a transparent safety standard that benefits the entire UK bio-economy. It turns a regulatory failure into a public-interest research infrastructure.