Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA

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.