Qualified health claim for whole-grain intake and risk of type 2 diabetes: an evidence-based review by the US Food and Drug Administration.

The objective of this review is to explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified health claim on the role of whole-grain consumption in reducing the risk of type 2 diabetes. The labeling of health claims, including qualified health claims, on conventional foods and dietary supplements requires premarket approval by the FDA. Health claims characterize the relationship between a substance (food or food component) and a disease (eg, diabetes or cardiovascular disease) or a health-related condition (eg, hypertension). This review describes the FDA's evaluation of intervention and observational studies that characterize a relationship between whole grains and type 2 diabetes. This evidence-based review provides very limited evidence to support a health claim of a relationship between intake of whole grains and a reduced risk of type 2 diabetes. Published by Oxford University Press on behalf of International Life Sciences Institute 2016. This work is written by US Government employees and is in the public domain in the United States.