Wholegrain health claim clears FDA procedure
beneficial actions of wholegrains on reduction of heart disease
risk, following an application from Kraft Foods.
The company submitted a health claim to the US Food and Drug Administration (FDA) in August, basing it on a recent NAS report, 'Diet and Health: Implications for Reducing Chronic Disease Risk'.
The report found that diets high in plant foods, including wholegrain cereals, are associated with a lower occurrence of coronary heart disease and cancers of the lung, colon, esophagus and stomach.
"Although the mechanisms underlying these effects are not fully understood, the inverse association with coronary heart disease may be largely explained by the usually low saturated fatty acid and cholesterol content of such diets. Such diets are also low in total fat, which is directly associated with the risk of certain cancers, but rich in complex carbohydrates (starches and fiber) and certain vitamins, minerals, trace elements, and nonnutritive constituents, and these factors probably also confer protection against certain cancers and coronary heart disease," says the report.
FDA reviewed the report and the existing authorized health claims and current science for coronary heart disease and received no additional comments from NAS. The claim therefore is allowed to be used from December 9, 120 days after notification with FDA.
The Kraft notification defined 'whole grain foods' as specified in the 1999 whole grain notification, as foods that contain 51 per cent or more whole grain ingredient(s) by weight per reference amount customarily consumed (RACC). FDA said it intends to assess compliance with this definition in the new health claim by reference to the dietary fiber level of whole wheat, the predominant grain in the US diet. Whole wheat contains 11 grams of dietary fiber per 100 grams; thus, the qualifying amount of dietary fiber required for a food to bear the prospective claim may be determined by the following formula: 11 grams x 51% x RACC/100.
A study published earlier this year found that eating wholegrain cereals can reduce likelihood of death from heart disease. In contrast, refined grain cereals had no effect on heart health.
More information on this method of establishing claims (ie based on an 'authoritative statement of a scientific body') is available on the FDA website.
