{"id":12215,"date":"2023-09-22T12:24:34","date_gmt":"2023-09-22T12:24:34","guid":{"rendered":"https:\/\/flm-gs.dev1.symbiotica.rs\/regulatory-hub\/%regulatory-category%\/health-claim-vs-nutrient-content-vs-structure-function\/"},"modified":"2026-03-13T09:03:44","modified_gmt":"2026-03-13T09:03:44","slug":"health-claim-vs-nutrient-content-vs-structure-function","status":"publish","type":"regulatory-hub","link":"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/","title":{"rendered":"Health vs. Nutrient Content vs. Structure Function Claims"},"content":{"rendered":"<p>Navigating the intricate world of food labeling and the regulatory requirements that come with it can be a chNavigating the intricate world of food labeling and the regulatory requirements that come with it can be a challenging task.\u00a0<\/p>\n\n\n\n<p>With various claims that can be made about a product\u2019s health benefits and nutritional content, it\u2019s essential to understand the differences and implications of each. One of the most common dilemmas faced by producers is understanding the distinction between a health claim vs structure function claim.\u00a0There are <strong>three primary types of FDA food label claims<\/strong> you will encounter: <strong>health claims<\/strong>, <strong>nutrient content claims<\/strong>, and <strong>structure\/function claims<\/strong>. By the end, you\u2019ll have a clearer understanding of each, ensuring that your <a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/nutrition-facts-software-cfia-compliant\/\">product\u2019s label is FDA compliant<\/a> and informative.<\/p>\n\n\n\r\n\r\n<div class=\"blog-post-cta clr-main-bg p-6\">\r\n    <div class=\"cta-holder\">\r\n                    <div class=\"title clr-white\"><p>See How <strong>FoodLabelMaker<\/strong> Can Help You<\/p>\n<\/div>\r\n        \r\n        <div class=\"btn-holder\">\r\n                            \t\t<a href=\"https:\/\/app.foodlabelmaker.com\/?action=demoRecipe&amp;src=createFreeLabel\" class=\"btn btn-primary px-5\" target=\"\">Create a Free Label<\/a>\r\n\t\t                                        \t\t<a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/pricing\/\" class=\"btn btn-primary px-5\" target=\"\">View Pricing Plans<\/a>\r\n\t\t                    <\/div>\r\n    <\/div>\r\n<\/div>\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_81 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #0f393a;color:#0f393a\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #0f393a;color:#0f393a\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#What_Are_FDA_Food_Label_Claims\" >What Are FDA Food Label Claims?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Summary_Table_Health_Nutrient_Content_StructureFunction_Claims\" >Summary Table: Health, Nutrient Content &amp; Structure\/Function Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Health_Claims\" >Health Claims<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Examples\" >Examples:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#What_it_is_not\" >What it is not:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Types\" >Types:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Requirements\" >Requirements:<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Authorized_Health_Claims\" >Authorized Health Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Qualified_Health_Claim\" >Qualified Health Claim<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Nutrient_Content_Claims\" >Nutrient Content Claims<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Examples-2\" >Examples:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#What_it_is_not-2\" >What it is not:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Types-2\" >Types:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Requirements-2\" >Requirements:<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#StructureFunction_Claims\" >Structure\/Function Claims<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Examples-3\" >Examples:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#What_it_is_not-3\" >What it is not:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Types-3\" >Types:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Categories\" >Categories:<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Requirements-3\" >Requirements:<\/a><\/li><\/ul><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#How_to_Choose_the_Right_Claim_for_Your_Product\" >How to Choose the Right Claim for Your Product<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Common_Mistakes_Food_Manufacturers_Make_with_Label_Claims\" >Common Mistakes Food Manufacturers Make with Label Claims<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Making_Disease_Claims_Without_FDA_Authorization\" >Making Disease Claims Without FDA Authorization<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Confusing_StructureFunction_Claims_with_Health_Claims\" >Confusing Structure\/Function Claims with Health Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Skipping_the_Supplement_Disclaimer\" >Skipping the Supplement Disclaimer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Using_Nutrient_Content_Claim_Language_Without_Meeting_the_Threshold\" >Using Nutrient Content Claim Language Without Meeting the Threshold<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Final_Thoughts_Health_Claims_vs_Nutrient_Content_vs_StructureFunction_Claims\" >Final Thoughts: Health Claims vs. Nutrient Content vs. Structure\/Function Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-28\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Frequently_Asked_Health_Claims_vs_Nutrient_Content_vs_StructureFunction_Questions\" >Frequently Asked Health Claims vs. Nutrient Content vs. Structure\/Function Questions<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-29\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#How_are_structurefunction_claims_different_from_health_claims\" >How are structure\/function claims different from health claims?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-30\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#Do_structurefunction_claims_need_FDA_approval\" >Do structure\/function claims need FDA approval?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-31\" href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/#What_is_the_difference_between_a_health_claim_vs_structure_function_claim\" >What is the difference between a health claim vs structure function claim?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Are_FDA_Food_Label_Claims\"><\/span><strong>What Are FDA Food Label Claims?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>FDA food label claims are statements that appear on food or dietary supplement packaging that go beyond the standard nutrition facts table. They are optional, but when a manufacturer chooses to include them, they must follow the FDA\u2019s food labeling regulations under the Federal Food, Drug, and Cosmetic Act.<\/p>\n\n\n\n<p>The FDA recognizes three distinct types of label claims:\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Health claims: Describe a food\u2019s potential health benefits.<\/li>\n\n\n\n<li>Nutrient content claims: Highlight the level of specific nutrients in a product.<\/li>\n\n\n\n<li>Structure\/function claims: Explain a nutrient or ingredient\u2019s role in the body\u2019s structure or function.<\/li>\n<\/ul>\n\n\n\n<p>Each one serves a different purpose, communicates a different kind of information to consumers, and operates under its own set of regulatory requirements.<\/p>\n\n\n\n<p>Food manufacturers, dietary supplement manufacturers, and anyone else responsible for a product label needs to understand which claim type applies to their product before any language goes on the packaging. Using the wrong claim type, or making a claim without meeting the applicable requirements, can result in a product being considered misbranded under FDA guidelines.<\/p>\n\n\n\n<p>It is also worth noting that the FDA does not conduct pre-market label approval for most food products. That means the responsibility for getting claims right falls on the manufacturer. The sections below break down each claim type in detail, including what qualifies, what does not, and what the requirements are for each.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-summary-table-health-nutrient-content-amp-structure-function-claims\"><span class=\"ez-toc-section\" id=\"Summary_Table_Health_Nutrient_Content_StructureFunction_Claims\"><\/span><strong>Summary Table: Health, Nutrient Content &amp; Structure\/Function Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Claim Type<\/strong><\/td><td><strong>Description<\/strong><\/td><td><strong>Example<\/strong><\/td><td><strong>What It Is Not<\/strong><\/td><td><strong>Requirements<\/strong><\/td><\/tr><tr><td><strong>Health Claim<\/strong><\/td><td>Describes the relationship between a food product and a reduced risk of a disease or health-related condition.<\/td><td>\u201cDiets low in sodium may reduce the risk of high blood pressure.\u201d<\/td><td>\u201cEating a balanced diet is important for overall well-being.\u201d<\/td><td>Must be complete, truthful, and not misleading.Cannot be about the diagnosis, cure, mitigation, or treatment of diseases.Certain foods may be disqualified based on nutrient levels.The substance must have a taste, aroma, or nutrient value at the levels used.<\/td><\/tr><tr><td><strong>Nutrient Content Claim<\/strong><\/td><td>Characterizes the level of a specific nutrient in a food product.<\/td><td>\u201cHigh in Vitamin C\u201d<\/td><td>\u201cGood for your health\u201d<\/td><td>Must accurately represent the nutrient level.Should not be misleading.Must meet the FDA\u2019s criteria for the specific claim.<\/td><\/tr><tr><td><strong>Structure\/Function Claim<\/strong><\/td><td>Describes the role of a nutrient or ingredient concerning the structure or function of the human body.<\/td><td>\u201cCalcium builds strong bones.\u201d<\/td><td>\u201cMay reduce the risk of heart disease\u201d<\/td><td>Should accurately represent the role of the nutrient or ingredient.Should not be misleading.Conventional food producers don\u2019t need to notify the FDA or make disclaimers.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>In the landscape of food labeling, it\u2019s crucial to discern between different types of claims. Health claims specifically highlight the relationship between a food product and its potential to reduce the risk of a disease or health condition. On the other hand, structure\/function claims emphasize how a nutrient or ingredient affects the body\u2019s structure or function. <\/p>\n\n\n\n<p>For instance, while a health claim might suggest that low-sodium-diets can mitigate high blood pressure risks, a structure\/function claim would underscore that calcium is instrumental in building strong bones.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-health-claims\"><span class=\"ez-toc-section\" id=\"Health_Claims\"><\/span><strong>Health Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Health claims are pivotal in food labeling as they describe the relationship between a food product and a reduced risk of a disease or a health-related condition. These claims can be made using words, images, or even references to third-party certifications.\u00a0<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-examples\"><span class=\"ez-toc-section\" id=\"Examples\"><\/span><strong>Examples:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cDiets low in sodium may reduce the risk of high blood pressure.\u201d<\/li>\n\n\n\n<li>\u201cIntake of calcium may support bone health.\u201d<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-what-it-is-not\"><span class=\"ez-toc-section\" id=\"What_it_is_not\"><\/span><strong>What it is not:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>It\u2019s essential to differentiate between health claims and general statements. For instance, \u201cEating a balanced diet is important for overall well-being\u201d is not a health claim. Such statements are more about dietary guidance and don\u2019t assert a reduced risk of a specific disease or health condition.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-types\"><span class=\"ez-toc-section\" id=\"Types\"><\/span><strong>Types:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Authorized Health Claims:<\/strong> These claims have been reviewed and approved by the FDA based on \u201csignificant scientific agreement.\u201d<\/li>\n\n\n\n<li><strong>Qualified Health Claims:<\/strong> These are claims supported by scientific evidence but don\u2019t meet the \u201csignificant scientific agreement\u201d standard. The FDA authorizes them with specific wording guidelines.<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-requirements\"><span class=\"ez-toc-section\" id=\"Requirements\"><\/span><strong>Requirements:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Health claims must be complete, truthful, and not misleading.<\/li>\n\n\n\n<li>They cannot be about the diagnosis, cure, mitigation, or treatment of diseases.<\/li>\n\n\n\n<li>Certain foods may be disqualified from health claims based on nutrient levels deemed unhealthy.<\/li>\n\n\n\n<li>The substance that is the subject of the health claim must have a taste, aroma, or nutrient value when consumed at the levels used to justify the claim.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-authorized-health-claims\"><span class=\"ez-toc-section\" id=\"Authorized_Health_Claims\"><\/span><strong>Authorized Health Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Authorized Health Claims describe a health claim that has been reviewed by the FDA and approved for use. There must be a robust scientific case for the FDA to issue an Authorized Health Claim. For instance, the claim \u201cEating soluble fiber from foods such as oatmeal, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease\u201d is an example of an authorized health claim.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-qualified-health-claim\"><span class=\"ez-toc-section\" id=\"Qualified_Health_Claim\"><\/span><strong>Qualified Health Claim<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>A Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements. When there\u2019s emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a \u201cQualified Health Claim\u201d.\u00a0<\/p>\n\n\n\n<p>An example might be: \u201cSome scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer.\u201d However,<a href=\"https:\/\/www.fda.gov\/food\/food-labeling-nutrition\/qualified-health-claims\"> the FDA has determined<\/a> that this evidence is limited and not conclusive.<\/p>\n\n\n\r\n\r\n<div class=\"blog-post-cta clr-main-bg p-6\">\r\n    <div class=\"cta-holder\">\r\n                    <div class=\"title clr-white\"><p>See How <strong>FoodLabelMaker<\/strong> Can Help You<\/p>\n<\/div>\r\n        \r\n        <div class=\"btn-holder\">\r\n                            \t\t<a href=\"https:\/\/app.foodlabelmaker.com\/?action=demoRecipe&amp;src=createFreeLabel\" class=\"btn btn-primary px-5\" target=\"\">Create FDA Food Label<\/a>\r\n\t\t                                <\/div>\r\n    <\/div>\r\n<\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nutrient-content-claims\"><span class=\"ez-toc-section\" id=\"Nutrient_Content_Claims\"><\/span><strong>Nutrient Content Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nutrient content claims characterize the level of a specific nutrient in a food product. These claims are different from the information listed in the Nutrition Information Panel. Any claims made about nutrition outside of this panel are considered nutrient content claims.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-examples-0\"><span class=\"ez-toc-section\" id=\"Examples-2\"><\/span><strong>Examples:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cHigh in Vitamin C\u201d<\/li>\n\n\n\n<li>\u201cLow Fat\u201d<\/li>\n\n\n\n<li>\u201cReduced Sodium\u201d<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-what-it-is-not-0\"><span class=\"ez-toc-section\" id=\"What_it_is_not-2\"><\/span><strong>What it is not:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>It\u2019s crucial to distinguish nutrient content claims from general health statements. For instance, \u201cGood for your health\u201d is not a nutrient content claim. Such statements are more general and don\u2019t specify the nutrient level in the product.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-types-0\"><span class=\"ez-toc-section\" id=\"Types-2\"><\/span><strong>Types:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Absolute Claims:<\/strong> These claims describe a product\u2019s nutrient level without comparing it to another product, e.g., \u201cHigh Fiber.\u201d<\/li>\n\n\n\n<li><strong>Comparative Claims:<\/strong> These claims compare the nutrient levels of two or more products, e.g., \u201cReduced Fat compared to regular chips.\u201d<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-requirements-0\"><span class=\"ez-toc-section\" id=\"Requirements-2\"><\/span><strong>Requirements:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The claim must accurately represent the nutrient level in the product.<\/li>\n\n\n\n<li>It should not be misleading to consumers.<\/li>\n\n\n\n<li>The nutrient level should meet the FDA\u2019s defined criteria for the specific claim being made.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-structure-function-claims\"><span class=\"ez-toc-section\" id=\"StructureFunction_Claims\"><\/span><strong>Structure\/Function Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Structure\/function claims describe the role of a nutrient or ingredient concerning the structure or function of the human body. These claims can appear on the labels of foods, dietary supplements, or even drugs.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-examples-1\"><span class=\"ez-toc-section\" id=\"Examples-3\"><\/span><strong>Examples:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cCalcium builds strong bones.\u201d<\/li>\n\n\n\n<li>\u201cFiber maintains bowel regularity.\u201d<\/li>\n\n\n\n<li>\u201cAntioxidants maintain cell integrity.\u201d<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-what-it-is-not-1\"><span class=\"ez-toc-section\" id=\"What_it_is_not-3\"><\/span><strong>What it is not:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>It\u2019s essential to differentiate structure\/function claims from disease claims. For instance, \u201cMay reduce the risk of heart disease\u201d outlines the difference between a health claim vs structure function claim.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-types-1\"><span class=\"ez-toc-section\" id=\"Types-3\"><\/span><strong>Types:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Claims of General Well-Being:<\/strong> These describe general well-being from consumption of a nutrient or ingredient.<\/li>\n\n\n\n<li><strong>Nutrient-Deficiency Disease Claims:<\/strong> These describe a benefit related to a nutrient deficiency disease (such as vitamin C and scurvy).<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-categories\"><span class=\"ez-toc-section\" id=\"Categories\"><\/span><strong>Categories:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>General Well-Being Claims:<\/strong> Describe general well-being from consumption of a nutrient or ingredient.<\/li>\n\n\n\n<li><strong>Nutrient-Deficiency Disease Claims:<\/strong> Describe a benefit related to a nutrient deficiency disease.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-requirements-1\"><span class=\"ez-toc-section\" id=\"Requirements-3\"><\/span><strong>Requirements:<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The claim should accurately represent the role of the nutrient or ingredient.<\/li>\n\n\n\n<li>It should not be misleading to consumers.<\/li>\n\n\n\n<li>Conventional food producers do not need to notify the FDA about structure\/function claims or make disclaimers associated with these claims on their product labels. However, producers of Dietary Supplements may face additional requirements.<\/li>\n<\/ul>\n\n\n\n<p><a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/wp-content\/uploads\/2023\/09\/FLM-005-C2-20-Health-Claim-Resource.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a> for a more in-depth guide on health claims according to the <a href=\"https:\/\/www.fda.gov\/files\/food\/published\/Food-Labeling-Guide-%28PDF%29.pdf\">FDA Food Labeling Guide<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_to_Choose_the_Right_Claim_for_Your_Product\"><\/span><strong>How to Choose the Right Claim for Your Product<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The right claim depends on what you want to communicate and how much scientific evidence you have to support it.<\/p>\n\n\n\n<p>If you want to highlight that a nutrient in your product may lower the risk of a disease or health condition, you are looking at a health claim. This requires FDA pre-authorization and the strongest level of scientific evidence. If the science exists but does not yet meet the significant scientific agreement standard, a qualified health claim may be an option, but it must include specific FDA-approved qualifying language.<\/p>\n\n\n\n<p>If you want to call attention to the level of a nutrient in your product, such as being low in sodium or high in fiber, a nutrient content claim is the right fit. These describe the composition of the food without linking it to disease or body function.<\/p>\n\n\n\n<p>If you want to explain what a nutrient does in the body, a structure\/function claim is your most flexible option. For conventional food manufacturers, these do not require FDA pre-approval or a disclaimer.<\/p>\n\n\n\n<p>A quick rule of thumb: if your claim mentions a disease or health condition, it needs FDA authorization. If it describes a nutrient level, it is a nutrient content claim. If it describes what a nutrient does in the body without referencing disease, it is a structure\/function claim.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-common-mistakes-food-manufacturers-make-with-label-claims\"><span class=\"ez-toc-section\" id=\"Common_Mistakes_Food_Manufacturers_Make_with_Label_Claims\"><\/span><strong>Common Mistakes Food Manufacturers Make with Label Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Even well-intentioned food manufacturers make errors with label claims, often because the lines between claim types aren\u2019t always obvious. Here are the most frequent mistakes to watch out for.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-making-disease-claims-without-fda-authorization\"><span class=\"ez-toc-section\" id=\"Making_Disease_Claims_Without_FDA_Authorization\"><\/span><strong>Making Disease Claims Without FDA Authorization<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The most serious mistake is placing a disease claim on a food or supplement label without FDA authorization. Statements like \u201cprevents heart disease,\u201d \u201creduces cancer risk,\u201d or \u201ctreats high blood pressure\u201d are not permitted unless the FDA has specifically authorized them as health claims.\u00a0<\/p>\n\n\n\n<p>Using this language can cause a product to be reclassified as a drug, triggering a completely different, and far more rigorous, regulatory pathway.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-confusing-structure-function-claims-with-health-claims\"><span class=\"ez-toc-section\" id=\"Confusing_StructureFunction_Claims_with_Health_Claims\"><\/span><strong>Confusing Structure\/Function Claims with Health Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>A structure\/function claim that veers too close to disease language can quickly become a problem. \u201cSupports healthy blood pressure\u201d may be permissible as a structure\/function claim, but \u201creduces the risk of hypertension\u201d would be treated as a health claim. Manufacturers should review the FDA\u2019s guidance on impermissible structure\/function claim language before finalizing any label copy.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-skipping-the-supplement-disclaimer\"><span class=\"ez-toc-section\" id=\"Skipping_the_Supplement_Disclaimer\"><\/span><strong>Skipping the Supplement Disclaimer<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Dietary supplement manufacturers sometimes omit the required disclaimer from structure\/function claims, or they place it in a location that is not clearly associated with the claim.\u00a0<\/p>\n\n\n\n<p>This is a compliance violation even if the underlying claim itself is substantiated and permissible. The disclaimer must appear on every label where a structure\/function claim is made.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-using-nutrient-content-claim-language-without-meeting-the-threshold\"><span class=\"ez-toc-section\" id=\"Using_Nutrient_Content_Claim_Language_Without_Meeting_the_Threshold\"><\/span><strong>Using Nutrient Content Claim Language Without Meeting the Threshold<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Terms like \u201chigh in,\u201d \u201cgood source of,\u201d \u201clow,\u201d \u201creduced,\u201d and \u201cfree\u201d each have specific FDA-defined criteria tied to nutrient levels per serving. Using these terms without meeting the applicable thresholds, even if the product is genuinely nutritious, is considered misbranding.\u00a0<\/p>\n\n\n\n<p>Manufacturers should verify that every nutrient content claim on their label aligns with the FDA\u2019s Food Labeling Guide before going to market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-final-thoughts-health-claims-vs-nutrient-content-vs-structure-function-claims\"><span class=\"ez-toc-section\" id=\"Final_Thoughts_Health_Claims_vs_Nutrient_Content_vs_StructureFunction_Claims\"><\/span><strong>Final Thoughts: Health Claims vs. Nutrient Content vs. Structure\/Function Claims<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Understanding the difference between FDA health claims, nutrient content claims, and structure\/function claims is one of the most important steps a food or supplement manufacturer can take toward building a compliant, trustworthy product label.<\/p>\n\n\n\n<p>Each claim type serves a distinct purpose. Health claims link a food or nutrient to a reduced risk of disease and require FDA authorization. Nutrient content claims describe the nutrient levels in your product using defined, permissible terms. Structure\/function claims explain what a nutrient does in the body and offer the most flexibility for conventional food manufacturers.<\/p>\n\n\n\n<p>Getting these distinctions right protects your product from being considered misbranded, keeps you on the right side of FDA regulations, and builds consumer confidence in what you are selling. Getting them wrong can be costly.<\/p>\n\n\n\n<p>Whether you are finalizing your first product label or auditing an existing one, Food Label Maker is built to help you navigate FDA food labeling requirements with confidence. Create a <a href=\"https:\/\/app.foodlabelmaker.com\/?action=demoRecipe&amp;src=createFreeLabel&amp;_gl=1*70qv0*_gcl_au*MTU3NDg3NjU0My4xNzY1ODY4MjAxLjE5MTMwODczNTguMTc3MTMyNDY1NS4xNzcxMzI0ODc4*_ga*NzU1NDY5NTk5LjE3NTc0MjIyMTM.*_ga_4KP5F0BHZF*czE3NzEzMjQ2NTUkbzM5JGcxJHQxNzcxMzI0ODgxJGo1NCRsMCRoNTc5MDI3Mzk0\">FDA compliant food label<\/a> or <a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/pricing\/\">view our pricing plans<\/a> to get started today.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-frequently-asked-health-claims-vs-nutrient-content-vs-structure-function-questions\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Health_Claims_vs_Nutrient_Content_vs_StructureFunction_Questions\"><\/span><strong>Frequently Asked Health Claims vs. Nutrient Content vs. Structure\/Function Questions<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-how-are-structure-function-claims-different-from-health-claims\"><span class=\"ez-toc-section\" id=\"How_are_structurefunction_claims_different_from_health_claims\"><\/span><strong>How are structure\/function claims different from health claims?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Health claims describe a relationship between a food or nutrient and a reduced risk of a specific disease or health condition, and they require FDA pre-authorization before they can appear on a label.\u00a0<\/p>\n\n\n\n<p>Structure\/function claims describe how a nutrient or ingredient supports the body\u2019s normal structure or function, without making any reference to disease.<\/p>\n\n\n\n<p>The distinction comes down to disease. \u201cCalcium may reduce the risk of osteoporosis\u201d is a health claim. \u201cCalcium builds strong bones\u201d is a structure\/function claim. One word or phrase can be the difference between a claim that needs FDA authorization and one that does not.<\/p>\n\n\n\n<p>Ready to make sure your label claims are compliant? <a href=\"https:\/\/app.foodlabelmaker.com\/sign-up?_gl=1%2a1b9klec%2a_gcl_au%2aMTU3NDg3NjU0My4xNzY1ODY4MjAxLjE5MTMwODczNTguMTc3MTMyNDY1NS4xNzcxMzI0NjU1%2a_ga%2aNzU1NDY5NTk5LjE3NTc0MjIyMTM.%2a_ga_4KP5F0BHZF%2aczE3NzEzMjQ2NTUkbzM5JGcwJHQxNzcxMzI0NjU1JGo2MCRsMCRoNTc5MDI3Mzk0\">Create a label<\/a> on Food Label Maker.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-do-structure-function-claims-need-fda-approval\"><span class=\"ez-toc-section\" id=\"Do_structurefunction_claims_need_FDA_approval\"><\/span><strong>Do structure\/function claims need FDA approval?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>For conventional food manufacturers, structure\/function claims do not require FDA pre-approval, and no disclaimer is needed on the product label. This makes them the most accessible claim type for food brands looking to communicate health benefits without going through a lengthy authorization process.<\/p>\n\n\n\n<p>Dietary supplement manufacturers face additional requirements. They must notify the FDA within 30 days of first marketing a product with a structure\/function claim, and must display a disclaimer on the label stating that the claim has not been evaluated by the FDA. In both cases, the claim must be truthful, not misleading, and supported by credible scientific evidence.<\/p>\n\n\n\n<p>Need help getting your structure\/function claims right? <a href=\"https:\/\/app.foodlabelmaker.com\/sign-up?_gl=1%2a1b9klec%2a_gcl_au%2aMTU3NDg3NjU0My4xNzY1ODY4MjAxLjE5MTMwODczNTguMTc3MTMyNDY1NS4xNzcxMzI0NjU1%2a_ga%2aNzU1NDY5NTk5LjE3NTc0MjIyMTM.%2a_ga_4KP5F0BHZF%2aczE3NzEzMjQ2NTUkbzM5JGcwJHQxNzcxMzI0NjU1JGo2MCRsMCRoNTc5MDI3Mzk0\">Sign up<\/a> to try Food Label Maker\u2019s label generator and see how easy compliant labeling can be.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-what-is-the-difference-between-a-health-claim-vs-structure-function-claim\"><span class=\"ez-toc-section\" id=\"What_is_the_difference_between_a_health_claim_vs_structure_function_claim\"><\/span>What is the difference between a health claim vs structure function claim?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Health claims and structure\/function claims both appear on food and supplement labels, but they have very different regulatory requirements.<\/p>\n\n\n\n<p><strong>Health claims<\/strong> describe a relationship between a food or nutrient and a reduced risk of disease. For example: \u201cDiets low in saturated fat and cholesterol may reduce the risk of heart disease.\u201d Unlike health claims made on conventional foods, which require FDA pre-authorization through a health claim petition or an authoritative statement, such claims carry a high evidentiary burden and strict approval process.<\/p>\n\n\n\n<p><strong>Structure\/function claims<\/strong> describe how a nutrient supports normal body structure or function without mentioning disease. For example: \u201cCalcium builds strong bones\u201d or \u201cFiber supports digestive health.\u201d These claims do not require FDA pre-approval, though dietary supplements must notify the FDA within 30 days of marketing and include a disclaimer stating that the claim has not been evaluated by the FDA.<\/p>\n\n\n\n<p>The key difference: health claims link to disease risk reduction and require authorization. Structure\/function claims describe normal body functions and do not require authorization.<\/p>\n\n\n\n<p>For a complete breakdown of supplement-specific claim requirements, see our<a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\"> <\/a>guide to <a href=\"https:\/\/flm-gs.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\">FDA dietary supplement claims<\/a>.<\/p>\n","protected":false},"author":5,"featured_media":12216,"parent":0,"template":"","meta":{"_acf_changed":true},"regulatory-category":[212],"class_list":["post-12215","regulatory-hub","type-regulatory-hub","status-publish","has-post-thumbnail","hentry","regulatory-category-fda"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.8 (Yoast SEO v27.1.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Health vs. Nutrient Content Claims | Food Label Maker<\/title>\n<meta name=\"description\" content=\"Learn how to distinguish between different types of FDA-regulated marketing claims. 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