{"id":1012,"date":"2014-10-03T08:00:02","date_gmt":"2014-10-03T14:00:02","guid":{"rendered":"https:\/\/www.ulprospector.com\/knowledge\/?p=1012"},"modified":"2021-04-01T15:24:10","modified_gmt":"2021-04-01T21:24:10","slug":"fbn-formulating-soluble-fiber","status":"publish","type":"post","link":"https:\/\/ulprospector.ul.com\/1012\/fbn-formulating-soluble-fiber\/","title":{"rendered":"Taking Fiber Claims to Heart"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-full wp-image-1024\" src=\"https:\/\/ulprospector.ul.com\/media\/2014\/10\/oatssm.jpg\" alt=\"oatssm\" width=\"300\" height=\"500\" srcset=\"https:\/\/ulprospector.ul.com\/wp-content\/uploads\/2014\/10\/oatssm.jpg 300w, https:\/\/ulprospector.ul.com\/wp-content\/uploads\/2014\/10\/oatssm-180x300.jpg 180w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>Health claims can be intimidating to achieve on packaging. However, the FDA has clearly outlined health claims around soluble fiber and coronary heart disease in <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.81\" target=\"_blank\" rel=\"noopener\">21 CFR 101.81<\/a> and <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.77\" target=\"_blank\" rel=\"noopener\">21 CFR 101.77<\/a>. With Americans lacking in fiber consumption (they eat, on average, less than half the daily requirement), formulating with soluble fiber to achieve a link to a reduced risk heart disease claim is feasible.<\/p>\n<p>When exploring the use of\u00a0health claims, you should always work closely with your legal counsel and regulatory advisors. However, this information should give you a head start when developing around a heart health claim.<\/p>\n<h4>Potential Claim Example:<\/h4>\n<ol>\n<li>Soluble fiber from foods such as oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of my product supplies 1 gram of the 3 grams of soluble fiber from oats necessary per day to have this effect.<\/li>\n<li>Diets low in saturated fat and cholesterol that include 3 grams of soluble fiber per day from oats may reduce the risk of heart disease. One serving of my product provides 1 gram of this soluble fiber.<\/li>\n<li>Implied health claim using symbols or images.<\/li>\n<\/ol>\n<h4>Soluble Fiber<\/h4>\n<p>Diets with 3 g or more of beta-glucan soluble fiber from whole oats or barley, or 7 g or more of <a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/search?k=soluble+fiber&amp;st=31\" target=\"_blank\" rel=\"noopener\">soluble fiber<\/a> (<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/search?k=soluble+fiber&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>) from <a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Product\/search?k=Psyllium+Seed+Husks&amp;sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">psyllium seed husk<\/a> (<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Product\/search?k=Psyllium+Seed+Husks&amp;sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>) have been associated with a reduced risk of coronary heart disease.<\/p>\n<p>Sources of approved soluble fiber ingredients are detailed in 21 CFR 101.81, and you can work with your vendor to find a source which meets the requirements.<\/p>\n<p><a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Product\/search?k=Beta-Glucan&amp;sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">Beta-glucan<\/a> (<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Product\/search?k=Beta-Glucan&amp;sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>) from Oat or Barley sources:<\/p>\n<ul>\n<li><a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/search?k=Whole+Grain+Oats&amp;st=31\" target=\"_blank\" rel=\"noopener\">Whole Grain Oats<\/a> (<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/search?k=Whole+Grain+Oats&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>); oat bran, rolled oats (oatmeal), whole oat flour and oatrim.<\/li>\n<li>Whole grain barley and dry milled barley; barley bran, barley flakes, barley grits, pearl barley, barley flour, barley meal, and sieved barley, and barley betafiber.<\/li>\n<\/ul>\n<p>Psyllium Husks<\/p>\n<ul>\n<li>Husks of the seed of Plantago ovata (P. indica, or P. psyllium)<\/li>\n<li>Note: Per CFR 21 101.17 you may require a label statement such as: \u2018\u2018NOTICE: This food should be eaten with at least a full glass of liquid. Eating this product without enough liquid may cause choking. Do not eat this product if you have difficulty in swallowing.\u2019\u2019<\/li>\n<\/ul>\n<h4>Total Formula Requirements:<\/h4>\n<p>To move toward a coronary heart disease claim, your product must meet general guidelines for health claims under <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.14\" target=\"_blank\" rel=\"noopener\">21 CFR 101.14.<\/a>\u00a0 In addition, foods must qualify for low fat, low saturated fat and low cholesterol defined in<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.62\" target=\"_blank\" rel=\"noopener\"> 21 CFR 101.62<\/a>, as well as contain a minimum fiber content of either beta-glucan or phyllium as outlined in <a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=101.81\" target=\"_blank\" rel=\"noopener\">21 CFR 101.81<\/a>.<\/p>\n<p><a href=\"https:\/\/ulprospector.ul.com\/media\/2014\/09\/claim1.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-1013\" src=\"https:\/\/ulprospector.ul.com\/media\/2014\/09\/claim1.png\" alt=\"claim1\" width=\"475\" height=\"149\" srcset=\"https:\/\/ulprospector.ul.com\/wp-content\/uploads\/2014\/09\/claim1.png 475w, https:\/\/ulprospector.ul.com\/wp-content\/uploads\/2014\/09\/claim1-300x94.png 300w\" sizes=\"(max-width: 475px) 100vw, 475px\" \/><\/a><\/p>\n<h4>Additional Formula considerations:<\/h4>\n<p>A quick formula calculation exercise will help you identify potential usage levels before you ever make a prototype. For example, calculate how much ingredient will need to be incorporated to achieve a minimum 0.75 grams of beta-glucan. Adjust the formula so the nutrition profile meets the minimum requirements.<\/p>\n<p>Often the limiting factor for soluble fiber will be taste and texture changes. However, several ingredients have been developed with high levels of beta-glucan from oat or barley sources, which will have less of an impact on sensory characteristics.<\/p>\n<p><b>Bakery:<\/b>\u00a0Fiber should be added in the dough stage, not the sponge stage, to minimize interaction with yeast. As you increase soluble fiber, you will need to adjust the water in the formula to accommodate the extra fiber and adjust the baking profile accordingly.<\/p>\n<p><strong>Beverages:<\/strong>\u00a0The fiber supplementation of choice has been resistant starches (colorless, flavorless, and easy to use). Using oat, barley or psyllium in beverages will increase viscosity. However, this increased thickness may provide a satisfying base for breakfast or meal replacement smoothies.<\/p>\n<p><strong>Meat:<\/strong>\u00a0These fibers are allowed as a binder in many products. Per the USDA FSIS, psyllium husk can be used up to 0.1% of total product weight and oat fiber up to 3.5% of the product formulation. A study in 2011 indicated that beta-glucan may enable a reduction in sodium or phosphates and still achieve product structure in processed chicken. If incorporated into a meal product, the soluble fiber content of meat may enable a health claim for the full meal if the rest of the guidelines are met.<\/p>\n<p><strong>Dairy:<\/strong>\u00a0Naturally high in protein, adding beta-glucan to dairy products will enable a powerful protein and fiber formula. To achieve a claim, be conscious of the sat fat and total fat of the finished product. The USDA ARS reported in March 2013 that a usage level of 0.3% refined beta-glucan, (yielding 0.75g\/ 8 oz serving) could be added into a low fat yogurt mix without sensory or performance changes.<\/p>\n<p><span style=\"font-size: 1.4rem; line-height: 1.625;\">In reviewing calculations\u00a0for your formulation, be sure to note that costs of materials increase as more concentrated forms of fiber are added, and this may impact your finished\u00a0product costs. Look at other fiber options\u00a0if cost becomes a substantial issue in commercializing a product.<\/span><\/p>\n<p><span style=\"font-size: 1.4rem; line-height: 1.625;\">No matter your product, make sure you collect data following the appointed AOAC methods (beta-glucan: method 992.28 and\u00a0 psyllium husk: modified method 991.43) to establish that your final product meets the requirements. Work with your legal and regulatory contacts to ensure they have the data repeated as needed.<\/span><\/p>\n<p><strong>Here are some ingredients to get you started:<\/strong><\/p>\n<p><a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Detail\/6220\/210363\/Barlv-Barley-Beta-Fiber?st=31\" target=\"_blank\" rel=\"noopener\">Barl\u00edv\u2122 Barley Beta Fiber<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Detail\/13355\/210363\/Barlv-Barley-Beta-Fiber?st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>) from <a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Suppliers\/6220\/Cargill-Industrial-Specialties\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">Cargill Industrial Specialties<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Suppliers\/13355\/Cargill-Food-Ingredients\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>)<br \/>\n<a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Detail\/6295\/239910\/OatWell-14?st=31\" target=\"_blank\" rel=\"noopener\">OatWell\u00ae 14<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Detail\/15324\/239910\/OatWell-14?st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>)\u00a0from <a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Suppliers\/6295\/DSM-Nutritional-Products--Inc\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">DSM Nutritional Products, Inc<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Suppliers\/15324\/DSM-Nutritional-Products--Inc\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>)<br \/>\n<a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Detail\/16681\/407510\/Psyllium-Husk-95-Pure?st=31\" target=\"_blank\" rel=\"noopener\">Psyllium Husk 95% Pure<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Detail\/16679\/407510\/Psyllium-Husk-95-Pure?st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>) from <a href=\"http:\/\/www.ulprospector.com\/en\/na\/Food\/Suppliers\/16681\/Psyllium-Labs--Inc\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">Psyllium Labs, Inc<\/a>\u00a0(<a href=\"http:\/\/www.ulprospector.com\/en\/eu\/Food\/Suppliers\/16679\/Psyllium-Labs--Inc\/search?sug=1&amp;st=31\" target=\"_blank\" rel=\"noopener\">EU<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Health claims can be intimidating to achieve on packaging. However, the FDA has clearly outlined health claims around soluble fiber and coronary heart disease in 21 CFR 101.81 and 21 CFR 101.77. With Americans lacking in fiber consumption (they eat, &hellip; <a href=\"https:\/\/ulprospector.ul.com\/1012\/fbn-formulating-soluble-fiber\/\">Continued<\/a><\/p>\n","protected":false},"author":4,"featured_media":1023,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","footnotes":""},"categories":[2],"tags":[],"ppma_author":[1254],"class_list":{"0":"post-1012","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-food-beverage-nutrition","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Formulating with Soluble Fiber - Reduced Risk Heart Disease<\/title>\n<meta name=\"description\" content=\"The FDA has clearly outlined health claims around soluble fiber and coronary heart disease.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ulprospector.ul.com\/1012\/fbn-formulating-soluble-fiber\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Formulating with Soluble Fiber - Reduced Risk Heart Disease\" \/>\n<meta property=\"og:description\" content=\"The FDA has clearly outlined health claims around soluble fiber and coronary heart disease.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/ulprospector.ul.com\/1012\/fbn-formulating-soluble-fiber\/\" \/>\n<meta property=\"og:site_name\" content=\"Prospector Knowledge Center\" \/>\n<meta property=\"article:published_time\" content=\"2014-10-03T14:00:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-01T21:24:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/ulprospector.ul.com\/wp-content\/uploads\/2014\/10\/Oats.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"496\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Jill Frank\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jill Frank\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/ulprospector.ul.com\\\/1012\\\/fbn-formulating-soluble-fiber\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/ulprospector.ul.com\\\/1012\\\/fbn-formulating-soluble-fiber\\\/\"},\"author\":{\"name\":\"Jill Frank\",\"@id\":\"https:\\\/\\\/ulprospector.ul.com\\\/#\\\/schema\\\/person\\\/09967ef4992af8cbbfc9a5be2d3fffa0\"},\"headline\":\"Taking Fiber Claims to Heart\",\"datePublished\":\"2014-10-03T14:00:02+00:00\",\"dateModified\":\"2021-04-01T21:24:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/ulprospector.ul.com\\\/1012\\\/fbn-formulating-soluble-fiber\\\/\"},\"wordCount\":873,\"image\":{\"@id\":\"https:\\\/\\\/ulprospector.ul.com\\\/1012\\\/fbn-formulating-soluble-fiber\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/ulprospector.ul.com\\\/wp-content\\\/uploads\\\/2014\\\/10\\\/Oats.jpg\",\"articleSection\":[\"Food, Beverage &amp; 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Jill serves as a consultant to all departments and monitors food industry trends and regulatory changes around the world. Her articles on these topics provide timely and relevant information for Prospector's\u00a0food industry members. In addition, Jill has played an integral role in optimizing and reorganizing the categorization of food ingredients within the Prospector\u00a0search engine. Her efforts help to provide an enhanced user experience that is customized to meet the needs of R&amp;D professionals in the food, beverage and nutrition industry. Prior to joining Prospector, Jill was a Bakery Applications Specialist for Dupont Nutrition &amp; Health, formerly Danisco USA, where she worked with the company\u2019s sales team and with the global development team to analyze and develop new products, custom solutions and sales literature. She has worked as a consultant for nutrition products, and has acted as a Manager and Director of Research and Development at companies in the bakery and nutrition fields. Jill held multiple titles with Gerber Products Company from 1995 \u2013 2004. During her tenure, she managed and developed formulas relating to bakery, cereal and dry blended products. Jill worked to create, improve and reformulate products, mindful of ingredient origins, nutritional value and consumer acceptability. Jill holds a B.S. in Bakery Science and Management from Kansas State University. She is a Certified Food Scientist, and is the President\u00a0of her local chapter of the Institute of Food Technologists. Jill is also an accomplished seamstress, textile designer and costume maker. 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Jill serves as a consultant to all departments and monitors food industry trends and regulatory changes around the world. Her articles on these topics provide timely and relevant information for Prospector's\u00a0food industry members. In addition, Jill has played an integral role in optimizing and reorganizing the categorization of food ingredients within the Prospector\u00a0search engine. Her efforts help to provide an enhanced user experience that is customized to meet the needs of R&amp;D professionals in the food, beverage and nutrition industry. Prior to joining Prospector, Jill was a Bakery Applications Specialist for Dupont Nutrition &amp; Health, formerly Danisco USA, where she worked with the company\u2019s sales team and with the global development team to analyze and develop new products, custom solutions and sales literature. 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