• Companies Seek Expansion of Soluble Fiber-Coronary Heart Disease Health Claim
  • July 12, 2013
  • Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
  • Two companies, DKSH Italia Srl and Polycell Technologies LLC, have filed a citizen petition with FDA asking that it expand the health claim on soluble fiber and coronary heart disease to include their product, Glucagel.  The petition describes Glucagel as a “barley beta-glucan fiber that provides a high purity (75%) form [that] lends itself to inclusion in a wide array of foods and beverages at rates of 1gram or more per serving.”

    If the petition is granted, the companies will be eligible to use model claims provided by FDA.  The model claims include information about how much soluble fiber a particular food source provides and state that the food source, “as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”  The companies propose that the qualifying level for  Glucagel “be consistent with the minimum of 3 grams per day of beta-glucan intake, as provided in 4 servings daily of a minimum of 0.75 grams per serving, as previously specified for oat bran, rolled oats, oat flour, specified oatrims, whole grain barley, certain dry milled barley products, and barley betafiber.”

    According to the petitioners, Glucagel “is efficacious in lowering serum cholesterol and related risk factors for [coronary heart disease]” and has been shown to “modulat[e] post-prandial blood glucose levels, [thereby] promoting satiety and helping in weight management.”  The petitioners further state that “barley beta-glucan soluble fibers have demonstrated cholesterol efficacy in a number of human studies using cooked, baked or otherwise prepared foods, using high purity isolates (>50% beta-glucan), concentrates (20-30% beta-glucan), and barley flours (<19% beta-glucan).”

    The petition provides a brief history of the soluble fiber-coronary heart disease health claim.  According to the petition, since first approving the health claim in 1997, FDA has allowed for expansions on four occasions.  First, in response to a 1998 petition by Kellogg Company, FDA expanded the health claim to include psyllium.  Next, in response to a 2002 petition by Quaker Oats Company and Rhodia, Inc., FDA expanded the health claim to cover Oatrim, which the companies described as an acid base and enzymatic hydrolosis produced beta-glucan concentrate.  Finally, in 2005 and 2008, respectively, FDA expanded the health claim to include whole grain and dry milled barley (under an interim final rule) and barley betafiber.  The National Barley Foods Council had sought the inclusion of whole grain and dry milled barley products.  Cargill, Inc. petitioned for the inclusion of barley betafiber.