FDA finalizes qualified health claim for barley products

The Food and Drug Administration announced May 19 that it has finalized a rule that allows foods containing whole-grain barley to claim that they reduce the risk of coronary heart disease. Specifically, whole barley and dry, milled barley products such as flakes, grits, flour, meal and barley meal, which provide at least 0.75 grams of soluble fiber per serving, may bear the following claim:

"Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect."

Coronary heart disease claims nearly half a million lives a year. High total cholesterol levels and high levels of low-density lipoprotein (LDL) cholesterol are known to increase one's risk for heart disease, so consumers are encouraged to keep these levels as low as possible. Scientific evidence indicates that including barley in a healthy diet can help reduce the risk of coronary heart disease by lowering LDL and total cholesterol levels.

"FDA is pursuing new initiatives to help consumers improve the choices they have for healthy and nutritious diets," said FDA Deputy Commissioner Scott Gottlieb, M.D. "We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so that they can make choices that are based on a better understanding of the health consequences of their diets."

FDA began allowing the claim in December 2005 under an interim final rule, while at the same time accepting public comments on the rule for 75 days. During this time no comments were received that warranted changes to the interim final rule.

Final Rule: www.fda.gov/ohrms/dockets/98FR/04p-0512-nfr0001.pdf

Interim Final Rule: www.cfsan.fda.gov/~lrd/fr051223.html.

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