Understanding the MHRA Borderline Medicines Department: Protecting Public Health and Clarifying Product Classification
In the complex world of consumer healthcare products, there is often a fine line between what constitutes a medicine, a cosmetic, a food supplement, or a medical device. This is where the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Borderline Medicines department plays a critical role. Tasked with determining the correct legal classification of borderline products, this department ensures that products are regulated appropriately to protect public health and support industry compliance.
What Are Borderline Products?
Borderline products are those that do not clearly fall into a single regulatory category. For example, a cream might be marketed for soothing irritated skin – is it a cosmetic, or a medicinal product? A herbal supplement might claim to “boost immunity” – is it a food supplement or a medicine? The classification matters significantly, as it determines the regulatory requirements a product must meet, including licensing, manufacturing standards, and permitted marketing claims.
The Role of the Borderline Team
The MHRA’s Borderline Medicines department assesses products on a case-by-case basis, taking into account their ingredients, intended purpose, method of use, and promotional materials. The key legal definition used comes from the Human Medicines Regulations 2012, which defines a medicinal product by either its presentation (claims made) or function (its actual effect on the body).
When a product is referred to the department – whether by companies seeking guidance, by other regulatory authorities, consumer concerns or even rival companies – the team conducts a detailed evaluation. They may request further information from the company, including product samples or scientific evidence. Based on their findings, they determine whether a product is classified as a medicine, and if so, whether it requires a marketing authorisation (licence) to be legally sold in the UK. The team review thousands of queries a year, and remove many incorrectly classified products from the market.
Current hot topics in the borderlines department
Fusion Pharma were lucky to attend the recent BHMA annual conference which was attended by the whole MHRA borderlines team. The current hot topics within the department include:
- The presence of undeclared medicinal substances in food supplements, such as the recent concerns of Melatonin being found in children’s nutrient gummies.
- Concerns around the use of celebrity deepfakes to advertise and endorse medicinal products
- Labelling of food supplements with ‘GLP1’ to deceive the public into thinking it has weight-loss actions.
- Labelling of products with ‘Research only’ to enable them to be sold without a marketing authorisation. These products however are being sold to the general public and not research institutes.
A Key Part of the Regulatory Landscape
In summary, the MHRA Borderline Products Department plays a vital but often behind-the-scenes role in the UK’s healthcare system. By carefully assessing product classifications, the team helps ensure that regulation keeps pace with innovation while safeguarding the public from potentially unsafe or misleading products.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
