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J Nutr. 2008 Jun;138(6):1228S-36S.

Generic and product-specific health claim processes for functional foods across global jurisdictions.

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School of Dietetics and Human Nutrition, McGill University, Ste-Anne-de-Bellevue, Quebec H9X 3V9, Canada.


Worldwide consumer interest in functional foods and their potential health benefits has been increasing over the past 10 y. To respond to this interest, regulatory bodies have developed guidelines for assessing health claims on functional foods. The objective of this article is to investigate the type and amount of evidence needed in various jurisdictions on a worldwide basis to substantiate both generic and product-specific health claims. Two types of health claims were examined using separate case studies. Analysis of generic health claims was highlighted by (n-3) fatty acids and their relation to heart health; whereas examination of product-specific health claims was conducted using probiotics and their association with gastrointestinal well-being. Results showed a common core for use of convincing high-quality human data, especially in the form of randomized controlled trials (RCT), but there was significant variability in the type and amount of scientific evidence needed to substantiate health claims, both generic and product specific, across different jurisdictions. Product-specific claims tended to use human RCT as the main basis for claims, whereas generic claims tended to base their statements on a wider spectrum of literature.

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