FDA approves health claim for barley

SPOKANE, Wash. (December 2005) – The US Food and Drug Administration (FDA) authorized use of a health claim for the role of beta-glucan soluble fiber from barley in reducing the risk of coronary heart disease.   The interim final rule was published in the Federal Register on December 23, 2005 and is in response to a petition submitted by the National Barley Foods Council.  Authorized use of the interim claim in barley food labeling is effective immediately.

According to the FDA, the following is an example of the health claim that may be used:
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.

The National Barley Foods Council submitted a health claim petition to the FDA in 2004 in cooperation with its member producer organizations, Idaho Barley Commission, Montana Wheat and Barley Committee, North Dakota Barley Council, Oregon Grains Commission and Washington Barley Commission.  The Council requested that the FDA amend the existing “Soluble fiber from certain foods and coronary heart disease health claim” at CFR 101.81 to include barley as a source of beta-glucan soluble fiber associated with reducing the risk of coronary heart disease.  The claim is based on consuming three grams of beta-glucan soluble fiber daily.

After reviewing the scientific evidence provided in the health claim petition, the FDA noted that five clinical trials testing the impact of consuming whole grain barley and dry milled barley products consistently reported statistically significant lower serum total and LDL-cholesterol levels.  In the trials, subjects consumed diets in which whole grain barley or dry milled barley product ingredients replaced wheat and rice ingredients.  A study published in 2004, for example, reported a six percent and eight percent reduction in LDL cholesterol following consumption of diets containing barley with three grams and six grams of beta-glucan soluble fiber, respectively.  For more specific information on barley clinical trials, click here.
 
In its decision to issue the interim ruling, the FDA took into consideration the fact that coronary heart disease continues to be the leading cause of death and permanent disability in the United States.  The FDA noted that allowing manufacturers of qualifying barley food products to use an interim health claim prior to a final ruling may result in a reduction in the risk of heart disease by helping at-risk consumers make healthier food choices now.

“Research has long shown that barley holds tremendous potential as a healthful food choice,” says Mary Sullivan, executive administrator of the National Barley Foods Council.  “The scientific evidence on barley beta-glucan soluble fiber and its ability to reduce cholesterol is significant and we are pleased that the FDA agrees with the findings and has authorized this claim.”

The FDA has identified several sources of barley beta-glucan soluble fiber that are eligible for the health claim.  These include whole grain barley, barley bran, barley flakes, barley grits, barley flour, barley meal, sieved barley meal and pearl barley produced from clean, sound dehulled or hulless barley using standard dry milling techniques.  To qualify for the health claim, a food made from these sources must contain at least 0.75 grams of barley beta-glucan soluble fiber per serving.

“Barley has a distinct advantage over some other grains in that beta-glucan soluble fiber is found throughout the entire barley kernel,” says Sullivan.  “In some other grains, the fiber is only found in the outer bran layer.  So if these grains are processed, the fiber can be easily lost.  This is not the case with barley,” says Sullivan.  “Even more refined products such as barley flour, barley flakes or barley meal contain beta-glucan soluble fiber which makes this grain an incredibly versatile ingredient for commercial food applications.  We fully expect to see a significant increase in new barley foods development and production in the future.”

For a full transcript of the FDA’s interim final ruling, click here.