OMAHA, NEBRASKA, U.S. — ConAgra Foods Inc. has filed a petition with the U.S. Food and Drug Administration (FDA) indicating there is “ample scientific evidence” for the authorization of a health claim about the relationship between whole grain consumption and a reduced risk of type II diabetes.
The petition, which was submitted to the FDA on Jan. 25 by Mark Andon, vice-president of nutrition, research, quality and innovation at ConAgra Foods, included an overview of scientific data from eight qualified observational trials and 20 randomized controlled trials in the U.S. suggesting consumption of whole grains reduces the incidence of type II diabetes.
Andon said some of the studies determined consuming whole grains daily reduced glucose and/or insulin, while other studies found substituting whole grains for refined grains increased daily dietary fiber intake by 10 grams and reduced fasting blood glucose concentrations and insulin resistance.
ConAgra provided two proposed model health claims consistent with the data presented in the petition:
• “Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.”
• “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”
Products that would be eligible for the proposed health claim would include whole grains defined as “consisting of the intact, ground, cracked or flaked caryopsis, whose principal anatomical components — the starchy endosperm, germ and bran — are present in the same relative proportions as they exist in the intact caryopsis,” as well as “whole grain containing products.”
“The information presented provides scientific evidence that suggests that whole grain consumption may reduce the incidence of (type 2 diabetes) in the U.S. population,” Andon said. “Since (type 2 diabetes) is a leading health problem for adults in the U.S., dietary strategies that incorporate increased consumption of whole grains and whole grain products are likely to have a significant and substantially positive public health outcome to the U.S. consumer without any negative health implications.”
If the FDA were to accept ConAgra’s petition it would join two other approved health claims about whole grains that were approved in 1999 and 2003, respectively.
• “Diets rich in whole grain foods and other plant foods and low in fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.”
• “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”
The petition, which is available at www.regulations.gov, is open to comments until May 11, and the FDA must respond by Oct. 23.