The Fragmented Regulatory Puzzle of so-called Botanicals in the EU between Food and Medicine

Abstract Botanical supplements occupy a regulatory grey area between food and medicine within the European Union, a situation that has given rise to a series of interrelated challenges. This paper highlights regulatory dysfunctions across several dimensions: definitional voids in EU food law, unclear food–medicine classification boundaries, fragmented market access rules, and inadequate safety monitoring systems. These regulatory gaps impose costs on business operators, restrict consumer access, and result in uneven protection across Member States. The article also focuses on safety concerns, which are, however only one element of this broader puzzle. To address such systemic difficulties, the paper proposes the introduction of harmonised pre-market notification and post-market surveillance mechanisms, with a specific focus on botanical supplements. These measures could help reconcile market accessibility with stronger consumer protection while supporting innovation. Admittedly, they may not resolve all regulatory challenges, particularly the thousands of health claims that remain on hold. Nevertheless, they might offer a practical foundation for addressing long-term, often overlooked safety concerns related to botanicals. It remains to be seen whether they could also contribute to resolving the interconnected regulatory issues in this sector, potentially paving the way for broader reform.