The UK's novel food journey for CBD has been a challenging, yet often rewarding, marathon. As September 2026 unfolds, operators, founders, boards, and investors are still navigating the complexities of the Food Standards Agency (FSA) public list and the rigorous scientific scrutiny applied by the Advisory Committee on Novel Foods and Processes (ACNFP).

However, a recent regulatory notice from the Department of Health and Social Care (DHSC) on MHRA reforms, though ostensibly concerning medicinal products, carries profound, yet subtly understood, implications for the CBD novel foods sector. This intersection demands a critical re-evaluation of current strategies and future planning.

The Ripple Effect of MHRA Reforms on Novel Foods

The DHSC's comprehensive impact assessment published on September 9, 2026, details the objectives, rationale, costs, and benefits of reforming the Medicines and Healthcare products Regulatory Agency. The core intent is to enhance regulatory agility, streamline approval processes, and bolster patient safety for medicines and medical devices. While CBD novel foods fall under the FSA's purview, not the MHRA's medicinal product remit, the philosophical shift and strengthened capabilities within the broader UK health regulatory apparatus are set to create significant downstream pressure.

Heightened Expectations for Safety and Efficacy Data

One of the most critical, yet understated, consequences is the likely ratcheting up of expectations for safety and efficacy data across all health-related product categories. As the MHRA becomes more adept at leveraging real-world data, accelerating scientific evaluations, and demanding robust post-market surveillance for medicinal products, the ACNFP – working closely with the FSA – will inevitably feel emboldened, and perhaps compelled, to apply similar rigor to novel food applications.

For CBD novel food operators, this means:

  • More Intensive Dossier Validation: Expect ACNFP to scrutinise toxicological data, pharmacokinetic studies, and genotoxicity assessments with an even finer tooth comb. The days of 'sufficient data' being a moving target are giving way to a standard more aligned with pharmaceutical-grade substantiation.
  • Enhanced Post-Market Monitoring: While the FSA already requires ongoing monitoring, the MHRA's push for advanced post-market surveillance in medicines signals a broader regulatory trend. Operators must anticipate demands for more sophisticated adverse event reporting and greater transparency regarding consumer complaints.
  • Cross-Regulatory Synergy: Although distinct, the MHRA and FSA are both arms of the UK government committed to public health. Increased sophistication in one impacts the other. Intelligence sharing and best practices will undoubtedly flow, potentially leading to a more harmonised, and more demanding, approach to safety data across the board.

The Operator's Dilemma: Navigating the Evolving Standard

Consider the predicament of an operator with a CBD novel food dossier already submitted and awaiting validation, or one still in preparation. The goalposts, while not explicitly moved by the MHRA reforms for novel foods, are effectively being elevated due to the overall regulatory environment strengthening. A dossier that might have been deemed acceptable a year ago may now face additional queries or demands for supplementary data.

This presents a practical operator dilemma: Do you proactively strengthen your existing data package, anticipating future questions, or wait for ACNFP feedback, risking delays and additional costs? For boards and investors, this translates into a heightened risk profile for novel food ventures.

Practical Implications for Boards and Investors

Boards must now factor in increased R&D costs for robust toxicological studies and clinical safety data, even for novel foods. The days of solely relying on existing literature or minimal proprietary data for novel food applications are drawing to a close. Investment decisions need to account for longer timelines to validation and potentially higher capital expenditure to meet these evolving scientific benchmarks.

The 'public list' isn't just about inclusion; it's about sustained inclusion based on an ever-more rigorous understanding of safety. Brands must demonstrate not just absence of harm, but a clear, well-substantiated safety profile that stands up to increasingly sophisticated regulatory review. This may also influence how the FSA approaches the current 'authorised but not yet listed' category, potentially requiring further data for products that have been on the market under existing interim arrangements.

Medicexum's Recommendation

Medicexum advises a proactive stance. Operators should review their existing and planned novel food dossiers through the lens of heightened scrutiny. Engage with toxicology experts to identify potential gaps in safety data that might be flagged under a more rigorous review. For products already on the public list, reinforce post-market surveillance systems and prepare for potential future data requests.

This is not a time for complacency. The MHRA reforms signal a broader, systemic shift towards more robust health product regulation in the UK. While not a direct imposition on novel foods, the spirit and capability of these reforms will inevitably permeate the ACNFP's scientific evaluation, raising the bar for CBD novel food compliance. Founders, boards, and investors who recognise and adapt to this evolving standard will be best placed to secure their position in the UK's competitive CBD market.

Source: Impact assessment: Health Bill: MHRA reforms - impact assessments — DHSC