On 17 October 2025, the Medicines & Healthcare products Regulatory Agency (MHRA) published updated guidance on borderline products, clarifying how it determines whether a product should be regulated as a medicinal product or falls under other frameworks such as medical devices, cosmetics, food supplements, herbal products, or biocides. The update is particularly relevant for manufacturers and sellers whose products sit at the intersection of multiple regulatory regimes or are subject to complaints about being marketed as medicines.
What the Updated Guidance Covers
The revised MHRA guidance explains that product classification is determined on a case-by-case basis, with assessment focused on several key criteria, including:
- Claims made about the product’s purpose or benefits
- Properties of active ingredients
- Intended use
- Overall presentation to consumers
A key determinant remains whether a product achieves its primary effect through a pharmacological, immunological, or metabolic mode of action, which would indicate medicinal status under UK regulations.
The guidance further clarifies that products commonly considered borderline include:
- Cosmetics
- Food supplements
- Herbal products
- Biocides
- Medical devices
Where food supplements or other non-medicinal products make medicinal claims, they may be reclassified as medicines and become subject to medicines’ legislation.
The MHRA reiterates that complaints are prioritized based on potential risks to consumer health. While the agency emphasizes voluntary compliance, it notes that investigations may still lead to enforcement action where necessary.
To support companies seeking regulatory clarity, the MHRA continues to provide formal opinions via the Medicines Borderline Advice Form, which allows submissions covering up to four products per inquiry. The guidance also notes that non-UK companies exporting directly to UK consumers may fall outside MHRA jurisdiction, but such products may still be investigated.
Feedback Deadline
No formal feedback deadline has been specified for this guidance update.
Who It Matters
This update provides regulatory clarity on how borderline products are assessed in the UK, helping companies align product development, claims, and labeling with the correct legal framework. Clearer criteria support digital-ready compliance workflows, reduce the risk of misclassification, and help organizations address potential issues early without unnecessary regulatory burden.
Who This Is Relevant For
The guidance is relevant for Regulatory Affairs, Quality Assurance, Compliance, Product Development, Legal, and Digital or AI teams involved in product classification, claims review, market access, and post-market monitoring for cosmetics, supplements, medical devices, and related products.
Next Steps
Organizations should review existing and planned product claims, assess active ingredient properties, and evaluate intended use and presentation against the updated MHRA criteria. Where classification remains unclear, stakeholders should consider submitting a request via the Medicines Borderline Advice Form to obtain a formal regulatory opinion before market placement or claim changes.
As regulatory expectations around product classification continue to evolve, RegASK helps organizations stay ahead by monitoring guidance updates, assessing regulatory impact across product portfolios, and supporting informed decision-making on borderline classifications.
RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 157 countries.
FAQs
What are borderline products under UK MHRA guidance?
Borderline products are those that may fall under medicines regulation or other frameworks such as cosmetics, food supplements, medical devices, herbal products, or biocides, depending on their claims, composition, and intended use.
How does the MHRA determine if a product is a medicinal product?
The MHRA assesses factors including the claims made, active ingredient properties, intended use, presentation to consumers, and whether the product acts through pharmacological, immunological, or metabolic means.
Can food supplements be regulated as medicines in the UK?
Yes. Food supplements that make medicinal claims or meet the criteria for medicinal mode of action may be reclassified and regulated as medicines.
How can RegASK support teams managing borderline product classifications?
RegASK helps teams track MHRA guidance updates, assess classification risks across products, and streamline regulatory intelligence and compliance workflows using agentic AI combined with expert oversight.
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