title: Qualified health claim for whole-grain intake and risk of type 2 diabetes: an evidence-based review by the US Food and Drug Administration.
abstract: 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.
authors: Sedigheh Yamini and Paula R. Trumbo are with the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland, USA. essie.yamini@fda.hhs.gov.
authors: Sedigheh
authors: S
authors: Yamini
authors: Sedigheh Yamini and Paula R. Trumbo are with the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland, USA.
authors: Paula R
authors: PR
authors: Trumbo
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D004032:Diet; D002523:Edible Grain; D019317:Evidence-Based Medicine; D005515:Food Labeling / Q000331:legislation & jurisprudence*; D006293:Health Promotion / Q000331:legislation & jurisprudence; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
keywords: diabetes; health claim; type 2 diabetes; whole grains