Borderline products: how to tell if your product is a medicine

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the classification of 'borderline products'—items such as food supplements, cosmetics, and herbal products that may be legally defined as medicines or medical devices. Operating under the framework of The Human Medicines Regulations 2012, the MHRA determines a product's status based on its intended purpose, how its ingredients affect the body, and the medicinal claims made in its marketing. The primary regulatory issue involves companies marketing products with health-related claims, such as treating or preventing disease, without obtaining the necessary marketing authorization. For the statistical period of November 2025 to April 2026, the agency processed 96 cases and executed 250 online marketplace takedowns. The MHRA prioritizes investigations based on consumer safety risks and typically seeks to resolve violations through voluntary compliance. This often involves companies amending their product formulations or removing medicinal claims from promotional materials, including websites and social media. To ensure compliance, manufacturers and sellers are required to review existing guidance and, if uncertain, submit a formal request for a regulatory opinion via the Medicines Borderline Advice Form. The agency emphasizes that even natural or herbal ingredients do not exempt a product from being classified as a medicine if its presentation suggests therapeutic benefits.