FDA approves tenuous health claim for whole grains and type 2 diabetes

October 2, 2013

The U.S. Food and Drug Administration (FDA) has approved ConAgra Food’s petition for a qualified health claim that links whole grain consumption to a reduced risk of developing type 2 diabetes. However, the FDA stated that based on the scientific evidence submitted with the petition and other pertinent scientific evidence, it concludes that “there is very limited credible scientific evidence for a qualified health claim for whole grains and type 2 diabetes.”

ConAgra Foods Inc. filed the petition with the FDA on Jan. 27, 2012, after which the FDA filed the petition for comprehensive review on March 12, 2012, and posted the petition on the FDA website for a 60-day comment period. The evidence for a relationship between whole grain intake and type 2 diabetes risk was based on six intervention studies and two publications that together contain a total of six analyses of three prospective cohort studies. There were four analyses of three observational studies and one intervention study supporting an association between whole grains and reduced risk of type 2 diabetes, while five intervention studies and two additional analyses of observational studies found no evidence of such a relationship.

In addition to these individual studies, the FDA also considered the evaluation of whole grains and risk of type 2 diabetes that was done as part of the development of the Dietary Guidelines for Americans, 2010 (DGAC). Based on the USDA Nutrition Evidence Library review, the DGAC concluded that there was limited evidence showing an association between whole grain consumption and reduced incidence of type 2 diabetes in large prospective cohort studies. “Limited” is the lowest grade of evidence assigned by the DGAC and reflects either a small number of studies, studies of weak design, and/or inconsistent results. The FDA agrees with the DGAC that the limitations of the evidence suggesting a relationship between whole grain intake and reduced risk of type 2 diabetes justify the DGAC’s lowest grade for strength of the evidence. In fact, taking into account the DGAC’s findings and the additional studies FDA reviewed, the agency concludes that the evidence supporting a risk reduction relationship, while credible, falls near the lower end of the “limited” category and should be described as “very limited” in food labeling to avoid misleading consumers.

Food manufacturers will now be able to communicate that whole grains and whole grain-containing foods that meet certain nutrient requirements outlined by the FDA may reduce the risk of type 2 diabetes. The FDA intends to consider exercising its enforcement discretion for the following qualified health claims:

  • “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”

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.”

“We were the originator of this petition and we’re thrilled the FDA is confirming that whole grains have a positive effect on people’s health and well-being and can help reduce the risk of developing type 2 diabetes,” said Al Bolles, Executive Vice President, Research, Quality, and Innovation at ConAgra Foods.

FDA letter (pdf)

ConAgra press release