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==FDA-approved health claims== The FDA allows manufacturers of foods containing 1.7 g per serving of psyllium husk soluble fiber or 0.75 g of [[oat]] or [[barley]] soluble fiber as [[beta-glucans]] to [[health claim|claim]] that regular consumption may reduce the risk of [[heart disease]].<ref name=FDAc>[http://www.cfsan.fda.gov/~dms/2lg-xc.html FDA/CFSAN A Food Labeling Guide: Appendix C Health Claims, April 2008] {{webarchive|url=https://web.archive.org/web/20080412090421/http://www.cfsan.fda.gov/~dms/2lg-xc.html |date=12 April 2008 }}</ref> The FDA statement template for making this claim is: {{Blockquote|Soluble fiber from foods such as [name of soluble fiber source, and, if desired, name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food product] supplies __ grams of the [necessary daily dietary intake for the benefit] soluble fiber from [name of soluble fiber source] necessary per day to have this effect.<ref name=FDAc/>}} Eligible sources of soluble fiber providing beta-glucan include: * Oat bran * Rolled oats * Whole oat flour * Oatrim * Whole grain barley and dry milled barley * Soluble fiber from psyllium husk with purity of no less than 95% The allowed label may state that diets low in saturated fat and cholesterol and that include soluble fiber from certain of the above foods "may" or "might" reduce the risk of heart disease. As discussed in FDA regulation 21 CFR 101.81, the daily dietary intake levels of soluble fiber from sources listed above associated with reduced risk of [[coronary heart disease]] are: * 3 g or more per day of beta-glucan soluble fiber from either whole oats or barley, or a combination of whole oats and barley * 7 g or more per day of soluble fiber from psyllium seed husk.<ref>Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease, U.S. Government Printing Office, Electronic Code of Federal Regulations, Title 21: Food and Drugs, part 101: Food Labeling, Subpart E, Specific Requirements for Health Claims, 101.81 [http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=77ed7da9463357d9a09892213e5c74db&rgn=div8&view=text&node=21:2.0.1.1.2.5.1.12&idno=21] {{webarchive|url=https://web.archive.org/web/20080601040856/http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=77ed7da9463357d9a09892213e5c74db&rgn=div8&view=text&node=21%3A2.0.1.1.2.5.1.12&idno=21|date=1 June 2008}}</ref> Soluble fiber from consuming grains is included in other allowed health claims for lowering risk of some types of cancer and heart disease by consuming fruit and vegetables (21 CFR 101.76, 101.77, and 101.78).<ref name=FDAc/> In December 2016, the FDA approved a qualified health claim that consuming resistant starch from high-[[amylose]] corn may reduce the risk of [[type 2 diabetes]] due to its effect of increasing [[insulin sensitivity]]. The allowed claim specified: "High-amylose maize resistant starch may reduce the risk of type 2 diabetes. The FDA has concluded that there is limited scientific evidence for this claim."<ref>{{cite web| vauthors = Balentine D |title=Petition for a Health Claim for High-Amylose Maize Starch (Containing Type-2 Resistant Starch) and Reduced Risk Type 2 Diabetes Mellitus (Docket Number FDA2015-Q-2352)|url=https://www.fda.gov/downloads/food/ingredientspackaginglabeling/labelingnutrition/ucm546963.pdf|publisher=Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration|date=12 December 2016|access-date=22 March 2018}}</ref> In 2018, the FDA released further guidance on the labeling of isolated or synthetic dietary fiber to clarify how different types of dietary fiber should be classified.<ref>{{cite web|url=https://www.foodnavigator-usa.com/Article/2018/06/15/FDA-unveils-dietary-fibers-guidance-Good-news-for-inulin-polydextrose-some-gray-areas-remaining|title=FDA unveils dietary fibers guidance: Good news for inulin, polydextrose, some gray areas remaining|publisher=FoodNavigatorUSA.com|first=Elaine |last=Watson|date=14 June 2018|language=en|access-date=24 June 2019}}</ref>
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