Food Claims Centre Venlo, Campus Venlo, Maastricht University, P.O. Box 8, Venlo 5900 AA, the Netherlands.
Food Claims Centre Venlo, Campus Venlo, Maastricht University, P.O. Box 8, Venlo 5900 AA, the Netherlands.
Health Policy. 2022 Aug;126(8):731-737. doi: 10.1016/j.healthpol.2022.05.011. Epub 2022 May 23.
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.
荷兰药品监测中心 Lareb 收到越来越多关于处于非注册健康增强产品灰色地带的产品的报告，包括补充剂。目前，对于这些可疑不良事件的自发报告，没有结构监测方法来处理。这项探索性研究确定了荷兰是否可以组织一个监测框架，以防止消费者因食用健康增强食品而产生不良反应。进行的访谈表明，相关组织形成了一个复杂的网络，没有正式的治理结构。组织缺乏处理报告的法律依据，而代表们确实认为有必要认真对待报告。受访者确定了各种改进监测的机会，包括提高消费者的意识。在我们的研究之后，Lareb 被正式指定研究不良事件，这是朝着提高安全性迈出的第一步。荷兰卫生部宣布了进一步提高食品补充剂安全性的措施，但尚未实施。由于在欧盟内外对监测的治理方法存在很大差异，因此仍有必要进一步分析如何最好地组织营养监测，以刺激消费者免受不安全物质的侵害。
