This study aims at understanding how scientific evidence to substantiate nutrition and health claims in food commercial communication is regulated in Europe and the USA. A literature review was performed on the scientific evidence required by the European Food Safety Authority and the US Food and Drug Administration to substantiate food nutrition and health claims. Studies published in Scopus, Medline, Scirus, and Google Scholar from 2007 to 2012 were reviewed as well as documents released by both agencies. A total of 38 documents met our inclusion criteria out of 743 documents initially identified during our search. These agencies provide general guidelines on how to conduct food and health studies, intended to demonstrate a cause-and-effect relationship between a given food and a benefit to health. Despite this, they need to broaden the depth and scope of the guidelines provided to companies seeking to substantiate their claims and to provide further and more precise information concerning the evaluation of studies and application processes. No review has hitherto specifically focused on the subject of scientific evidence required by EU and US food agencies to substantiate health claims. This research thus leads to significant recommendations on how to improve current food industry guides.

中文翻译：

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功能性食品及其商业传播的科学证据：欧洲和美国立法回顾

本研究旨在了解欧洲和美国如何监管在食品商业传播中证实营养和健康声明的科学证据。对欧洲食品安全局和美国食品和药物管理局要求的科学证据进行了文献审查，以证实食品营养和健康声明。对 2007 年至 2012 年在 Scopus、Medline、Scirus 和 Google Scholar 上发表的研究以及这两个机构发布的文件进行了审查。在我们搜索期间最初确定的 743 份文件中，共有 38 份文件符合我们的纳入标准。这些机构提供关于如何进行食品和健康研究的一般指南，旨在证明给定食品与健康益处之间的因果关系。尽管如此，他们需要扩大向寻求证实其主张的公司提供的指南的深度和范围，并提供关于研究和申请过程评估的进一步和更准确的信息。迄今为止，没有任何审查专门针对欧盟和美国食品机构要求的科学证据主题，以证实健康声明。因此，这项研究就如何改进当前的食品行业指南提出了重要建议。