Department of Clinical Pharmacy and Pharmaceutical Care, Faculty of Pharmacy with the Laboratory Medicine Division, Medical University of Warsaw, Poland.
Department of Clinical Pharmacy and Pharmaceutical Care, Faculty of Pharmacy with the Laboratory Medicine Division, Medical University of Warsaw, Poland.
Regul Toxicol Pharmacol. 2018 Aug;97:98-102. doi: 10.1016/j.yrtph.2018.06.014. Epub 2018 Jun 19.
Food supplements have been playing an increasingly important role in the consumers' awareness nowadays. They are widespread and - according to popular belief - healthier and safer than synthetic drugs. In the European Union (EU) food supplements are classified as foodstuffs and thus not subjected to any specific safety assessments prior to commercialisation. With the growing popularity of food supplements, there is an increased need for more effective control of their production and distribution. The aim of this study was to examine the food notifications, recorded since 2003 via the EU RASFF database with particular regard to recent years, as well as to evaluate the involvement of different EU state structures in the fight against drug-adulterated food supplements with regard to efficacy and safety. In recent years, the number of RASFF notifications in the category of dietetic foods, food supplements and fortified foods, especially related to unauthorised composition, has increased significantly. The majority of EU Member States authorities, who responded to the study, consider drug-adulterated food supplements to be a public health threat. However, the competences of different official structures within the Member States concerning such products do not appear to be clearly defined. Regulators should thus think of stricter legislative solutions to increase the safety of public health.
如今,食品补充剂在消费者意识中扮演着越来越重要的角色。它们广泛存在,并且——根据普遍的看法——比合成药物更健康、更安全。在欧盟(EU),食品补充剂被归类为食品,因此在商业化之前不需要进行任何特定的安全评估。随着食品补充剂的日益普及,对其生产和分销的控制需要更加有效。本研究旨在通过欧盟 RASFF 数据库自 2003 年以来记录的食品通知,特别是近年来的情况,评估不同欧盟国家结构在打击掺杂药物的食品补充剂方面的有效性和安全性。近年来,RASFF 通知中关于饮食食品、食品补充剂和强化食品的类别,尤其是与未经授权的成分有关的通知数量显著增加。对这项研究作出回应的大多数欧盟成员国当局认为掺杂药物的食品补充剂对公共健康构成威胁。然而,成员国不同官方机构对这些产品的职权似乎没有明确界定。监管机构因此应该考虑采取更严格的立法措施,以提高公共健康的安全性。