Washington — The Food and Drug Administration will consider individually food manufacturers’ claims that consumption of whole grains and foods made with whole grains can reduce the risk of type 2 diabetes.
In a letter responding to a qualified health claims petition filed by ConAgra Foods, Inc., FDA Acting Director, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Philip C. Spiller writes: “FDA concludes there is very limited credible scientific evidence for a qualified health claim for whole grains and type 2 diabetes, provided that the qualified claim is appropriately worded so as not to mislead consumers.”
Consequently, Spiller writes, the agency will continue its enforcement discretion for two qualified health claims, similar in language, in labels of foods with grain ingredients consisting solely of whole grains: “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.”
However, he adds, the agency acknowledges that current evidence supports a qualified health claim on labels of whole grain-containing foods about the association between consuming whole grains and lowered risk of type 2 diabetes.
In its petition, filed in March 2012, ConAgra presented data from both observational trials and randomized controlled trials in the U.S. in support of two model health claims: “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,” and “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.”
Spiller’s letter notes that during the 60-day comment period following posting of ConAgra’s petition on the FDA website, three of 11 comments opposed the company’s proposed qualified health claims.
Whole grains led the list of most desirable health claims on packages in 2010, according to the Institute of Food Technologists, followed by claims about fiber, sodium, fats, sugar, calories, additives, preservatives and cholesterol.