Governance of nutrivigilance in the Netherlands: Reporting adverse events of non-registered products

Abstract

The Dutch Pharmacovigilance Centre Lareb receives an increasing number of reports on products that fall within the grey area of non-registered health-enhancing products, including supplements. Currently, there is no structural vigilance approach to handling these spontaneous reports of suspected adverse events. This explorative study identified whether and how a vigilance framework in the Netherlands can be organised to contribute to consumer protection from adverse reactions to health-enhancing food products. Conducted interviews showed that involved organisations form a complex network, without official governance structures. Organisations lack a legal basis to handling reports, whilst representatives do feel the need to take reports seriously. Interviewees identified various opportunities to improve vigilance, including raising consumer awareness. Following our study, first steps were taken towards improving safety by officially designating Lareb to study adverse events. Further advances to food supplement safety were announced by the Dutch Ministry but have not yet been implemented. With highly differing approaches to governing vigilance in- and outside the EU, it remains necessary to further analyse how nutrivigilance can be organised best to stimulate consumer protection from unsafe substances.

Keywords: Dietary supplements; Food law; Food safety; Qualitative research; Suspected adverse drug reactions; Vigilance.