{"id":17070,"date":"2025-11-06T19:46:25","date_gmt":"2025-11-06T19:46:25","guid":{"rendered":"https:\/\/flmdev.dev1.symbiotica.rs\/regulatory-hub\/%regulatory-category%\/fda-dietary-supplement-claims\/"},"modified":"2025-11-06T19:46:25","modified_gmt":"2025-11-06T19:46:25","slug":"fda-dietary-supplement-claims","status":"publish","type":"regulatory-hub","link":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/","title":{"rendered":"How to Make FDA-Compliant Dietary Supplement Claims"},"content":{"rendered":"<p>What\u2019s the difference between \u201cSupports Immune Health\u201d and \u201cCures the Flu\u201d?\u00a0<\/p>\n\n\n\n<p>Getting this line wrong defines your product as either a legal supplement or an illegal drug.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"200\" src=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-300x200.jpg\" alt=\" Assorted pills with top view\" class=\"wp-image-12279\" srcset=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-300x200.jpg 300w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-1024x682.jpg 1024w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-768x512.jpg 768w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-1536x1023.jpg 1536w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-900x600.jpg 900w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-645x430.jpg 645w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-420x280.jpg 420w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-318x212.jpg 318w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-290x193.jpg 290w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-630x420.jpg 630w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034-280x187.jpg 280w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tufd034.jpg 1600w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\"><figcaption class=\"wp-element-caption\"><a href=\"https:\/\/www.pexels.com\/photo\/assorted-pills-in-top-view-7605733\/\" target=\"_blank\" rel=\"noreferrer noopener\">Photo by Aleksandar Pasaric<\/a><\/figcaption><\/figure>\n<\/div>\n\n\n<p>Dietary Supplement Labeling, much like Nutrition Supplement Labeling, has its own set of rules and regulations that food manufacturers need to follow. An important section within these regulations is dedicated entirely to claims, detailing exactly what manufacturers can and cannot say on a supplement label.<\/p>\n\n\n\n<p>This article will give you a clear, step-by-step roadmap to navigate all supplement claim rules, ensuring your label is FDA-compliant.<\/p>\n\n\n\n<p>If you\u2019re unsure of how to get started on your supplements labeling, <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">book a demo<\/a> to understand how Food Label Maker can fit your specific needs.\u00a0<\/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>Formulate, Analyze, and Generate FDA-Compliant Supplement Labels  <\/p>\n<\/div>\r\n        \r\n        <div class=\"btn-holder\">\r\n                            \t\t<a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\" class=\"btn btn-primary px-5\" target=\"\">Book a Demo<\/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_80 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:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#What_Are_the_Three_Types_of_Claims_the_FDA_Allows_on_Dietary_Supplements\" >What Are the Three Types of Claims the FDA Allows on Dietary Supplements?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#StructureFunction_Claims_SF_%E2%80%93_The_Most_Common\" >Structure\/Function Claims (S\/F) \u2013 The Most Common<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Health_Claims_%E2%80%93_Needs_FDA_Approval\" >Health Claims \u2013 Needs FDA Approval<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Nutrient_Content_Claims_NCCs_%E2%80%93_Meet_Quantitative_Standards\" >Nutrient Content Claims (NCCs) \u2013 Meet Quantitative Standards<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Deep_Dive_High_Potency_Antioxidant_Percentage_Claims\" >Deep Dive: High Potency, Antioxidant, &amp; Percentage Claims<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#High_Potency_Claims_%E2%80%93_The_100_Test\" >High Potency Claims \u2013 The 100% Test<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Antioxidant_Claims_%E2%80%93_The_Three_Checks\" >Antioxidant Claims\u00a0 \u2013 The Three Checks<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Percentage_Claims_%E2%80%93_For_Non-DV_Ingredients\" >Percentage Claims\u00a0 \u2013 For Non-DV Ingredients<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Key_Differences_between_Supplement_and_Food_Claims\" >Key Differences between Supplement and Food Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Final_Check_Scientific_Evidence_is_Required\" >Final Check: Scientific Evidence is Required<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Conclusion_FDA_Dietary_Supplement_Claims\" >Conclusion: FDA Dietary Supplement Claims<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#Frequently_Asked_Questions\" >Frequently Asked Questions\u00a0<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#1_How_should_the_disclosure_statement_be_presented_on_my_supplements_label\" >1. How should the disclosure statement be presented on my supplements label?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#2_How_do_I_notify_the_FDA_once_I_make_a_structurefunction_claim_on_my_supplements_label\" >2. How do I notify the FDA once I make a structure\/function claim on my supplements label?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#3_Who_is_Food_Label_Makers_Supplement_Labeling_Tool_designed_for\" >3. Who is Food Label Maker\u2019s Supplement Labeling Tool designed for?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#4_How_does_the_Food_Label_Maker_software_stay_compliant_with_changing_FDA_regulations\" >4. How does the Food Label Maker software stay compliant with changing FDA regulations?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\" id=\"h-what-are-the-three-types-of-claims-the-fda-allows-on-dietary-supplements\"><span class=\"ez-toc-section\" id=\"What_Are_the_Three_Types_of_Claims_the_FDA_Allows_on_Dietary_Supplements\"><\/span>What Are the Three Types of Claims the FDA Allows on Dietary Supplements?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There are <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/\">three categories<\/a> of claims for both conventional foods and dietary supplements:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Structure\/Function Claims:<\/strong> explains a nutrient or ingredient\u2019s role in the body\u2019s structure or function<\/li>\n\n\n\n<li><strong>Health Claims:<\/strong> describe a food\u2019s potential health benefits<\/li>\n\n\n\n<li><strong>Nutrient Content Claims (NCCs): <\/strong>highlight the level of specific nutrients in a product<\/li>\n<\/ol>\n\n\n\n<p>For the FDA, your product\u2019s claims define its regulatory status. Getting claims right is the core of compliance.\u00a0<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-structure-function-claims-s-f-the-most-common\"><span class=\"ez-toc-section\" id=\"StructureFunction_Claims_SF_%E2%80%93_The_Most_Common\"><\/span>Structure\/Function Claims (S\/F) \u2013 The Most Common<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/\">Structure\/Function claims<\/a> describe the role of a nutrient and how it affects the human body. For example: \u201ccalcium builds strong bones\u201d or \u201c fiber maintains bowel regularity\u201d.<\/p>\n\n\n\n<p>According to <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-44:~:text=21%20CFR%20101.70-,Structure\/Function%20Claims,-What%20types%20of\" target=\"_blank\" rel=\"noreferrer noopener\">the FDA<\/a> a dietary supplement may have a structure\/function claim if:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>It\u2019s a benefit against a deficiency-related disease, provided you also state how common that deficiency is in the U.S.<\/li>\n\n\n\n<li>An ingredient supports, maintains, or affects the normal, healthy structure or function of the human body (e.g., \u201cbuilds strong bones\u201d).<\/li>\n\n\n\n<li>It\u2019s a broad statement about improved feelings of health or general well-being (e.g., \u201cpromotes general vitality\u201d).<\/li>\n<\/ol>\n\n\n\n<p><strong>NOTE: <\/strong>It\u2019s important to remember that you <strong>must not<\/strong> make a claim about the treatment of diseases, as this is considered a violation of FDA regulations:<\/p>\n\n\n\n<p>\u2705Good: \u201cSupports healthy cholesterol levels.\u201d<br>\u274cBad (Illegal Drug Claim): \u201cLowers high cholesterol.\u201d<\/p>\n\n\n\n<p>For any structure\/function claim made on your supplement facts label, you must <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-44:~:text=343(r)(6)-,What%20must%20I%20do%20when%20making%20structure\/function%20claims%20in%20my%20products%27%20labeling%3F,-You%20must%20(1\">notify<\/a> the FDA within 30 days of the claim.\u00a0<\/p>\n\n\n\n<p>The FDA guidelines also state supplement manufacturers must include the following <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-44:~:text=21%20CFR%20101.93-,What%20text%20must%20I%20use%20for%20the%20disclaimer%3F,-You%20must%20use\" target=\"_blank\" rel=\"noreferrer noopener\">disclaimer text<\/a>, <strong>without modifying<\/strong> any of the wording:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Singular: \u201cThis statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.\u201d<\/li>\n\n\n\n<li>Plural: \u201cThese statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.\u201d<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-health-claims-needs-fda-approval\"><span class=\"ez-toc-section\" id=\"Health_Claims_%E2%80%93_Needs_FDA_Approval\"><\/span>Health Claims \u2013 Needs FDA Approval<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-1:~:text=3)(ii)(B)-,Health%20Claims,-What%20is%20a\" target=\"_blank\" rel=\"noreferrer noopener\">Health Claims<\/a> describe the relationship between a substance and a disease\/health-related condition. These claims must be authorized by the FDA and are required to have copious amounts of scientific evidence in order to be made, and before they\u2019re released to market. Because of this, health claims are considered to be significantly harder to attain.<\/p>\n\n\n\n<p>There are <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/\">two types<\/a> of health claims:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Authorized Health Claims: <\/strong>These claims have been reviewed and are fully approved by the FDA based on \u201csignificant scientific agreement.\u201d (SSA)<\/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, and they must include a statement clearly explaining the lack of scientific agreement.<\/li>\n<\/ol>\n\n\n\n<p>Some examples of Authorized Health Claims are:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u201cAdequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.\u201d \u2192 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\/subpart-E\/section-101.72\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Regulation 21 CFR 101.72<\/a><\/li>\n\n\n\n<li>\u201cDiets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain soluble fiber, may reduce the risk of heart disease.\u201d \u2192 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\/subpart-E\/section-101.81\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Regulation 21 CFR 101.81<\/a><\/li>\n\n\n\n<li>\u201cHealthful diets with adequate folate may reduce a woman\u2019s risk of having a child with a brain or spinal cord birth defect.\u201d \u2192 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\/subpart-E\/section-101.79\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Regulation 21 CFR 101.79<\/a><\/li>\n\n\n\n<li>\u201cDiets low in saturated fat and cholesterol that include 25g of soy protein a day may reduce the risk of heart disease.\u201d \u2192 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\/subpart-E\/section-101.82\" target=\"_blank\" rel=\"noreferrer noopener\">FDA Regulation 21 CFR 101.82<\/a><\/li>\n<\/ol>\n\n\n\n<p><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\/subpart-E?toc=1\" target=\"_blank\" rel=\"noreferrer noopener\">Read the FDA\u2019s full list<\/a> of authorized health claims to ensure your health claim statement would be approved by the regulatory body.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-nutrient-content-claims-nccs-meet-quantitative-standards\"><span class=\"ez-toc-section\" id=\"Nutrient_Content_Claims_NCCs_%E2%80%93_Meet_Quantitative_Standards\"><\/span>Nutrient Content Claims (NCCs) \u2013 Meet Quantitative Standards<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/health-claim-vs-nutrient-content-vs-structure-function\/\">Nutrient Content Claims (NCCs)<\/a> characterize the amount or level of a nutrient contained in a dietary supplement. They are about quantitative math, rather than effects.<\/p>\n\n\n\n<p>Here is a table of the nutrient content claims specifically defined <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-1:~:text=CFR%20101.13(b)-,Where%20may%20I%20find%20nutrient%20content%20claims%20specifically%20defined%20by%20the%20FDA%3F,-You%20may%20find\" target=\"_blank\" rel=\"noreferrer noopener\">by the FDA<\/a> with their requirements:<\/p>\n\n\n\n<figure class=\"wp-block-table flm-header\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Nutrient Content Claim<\/strong><\/td><td><strong>FDA Regulation for Dietary Supplements<\/strong><\/td><\/tr><tr><td><strong>\u201cHigh\u201d claims<\/strong><\/td><td>Contains <strong>20%<\/strong> or more of the Recommended Daily Intake (RDI) or the Dietary Reference Value (DRV) per reference amount customarily consumed (RACC).<\/td><\/tr><tr><td><strong>\u201cGood Source\u201d claims<\/strong><\/td><td>Contains <strong>10-19% <\/strong>of the RDI or the DRV per reference amount customarily consumed (RACC).<\/td><\/tr><tr><td><strong>\u201cMore\u201d claims<\/strong><\/td><td>Contains at least <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/101.54\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>10% more<\/strong> of the Daily Value (DV)<\/a> of the nutrient than the food it is being compared against.<\/td><\/tr><tr><td><strong>\u201cHigh potency\u201d claims<\/strong><\/td><td>Used only for vitamins\/minerals at <strong>100% or more<\/strong> of the RDI (or 2\/3 of vitamins\/minerals for multi-products).<\/td><\/tr><tr><td><strong>\u201cAntioxidant\u201d claims<\/strong><\/td><td><a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/101.54\" target=\"_blank\" rel=\"noreferrer noopener\">Established RDI Value<\/a> and \u201cGood Source\u201d (\u226510% DV) or \u201cHigh\u201d (\u226520% DV) claim.<\/td><\/tr><tr><td><strong>\u201cLight\u201d or \u201cLite\u201d claims<\/strong><\/td><td>Requires either <strong>50% less fat<\/strong> or <strong>1\/3 fewer calories<\/strong> than the original version of the product being compared.\u201dLight\u201d and \u201cLite\u201d claims are exceptionally rare on supplement labels. The reason is simple: these terms are relative claims that require a direct comparison to a \u201cregular\u201d version of the product, which most supplements do not have.<\/td><\/tr><tr><td><strong>\u201cCalorie or Sugar\u201d claims<\/strong><\/td><td>Terms like \u201cFree\u201d or \u201cLow\u201d require the product to contain a <strong>nutritionally insignificant amount<\/strong> based on specific, low FDA thresholds.<\/td><\/tr><tr><td><strong>\u201cSodium or Salt\u201d claims<\/strong><\/td><td>\u201cLow Sodium\u201d requires <strong>140mg or less per serving<\/strong><br>\u201cSodium Free\u201d requires <strong>less than 5mg per serving.<\/strong><\/td><\/tr><tr><td><strong>\u201cFat, fatty acids, and cholesterol\u201d claims<\/strong><\/td><td>Terms like \u201cFree\u201d (e.g., Fat-Free, Saturated Fat Free, Cholesterol-Free) must meet strict, low FDA limits per labeled serving (e.g., &lt;0.5g for Saturated Fat-Free).\u00a0These claims are often avoided for supplements high in beneficial fats (like fish oils).<\/td><\/tr><tr><td><strong>Implied nutrient content claims<\/strong><\/td><td>Any word or symbol that suggests a nutrient level (e.g., using \u201cMega\u201d or a checkmark) must <strong>meet the legal definition<\/strong> of the implied claim (like \u201cHigh\u201d or \u201cGood Source\u201d).<\/td><\/tr><tr><td><strong>\u201cHealthy\u201d claims<\/strong><\/td><td>Supplements generally <strong>do not qualify<\/strong> as this claim is designed for conventional food diets.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Other than the nutrient content claims listed, a supplement manufacturer or R&amp;D specialist, must use a <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-1:~:text=CFR%20101.13(n)-,What%20is%20a%20disclosure%20statement%3F,-It%20is%20a\" target=\"_blank\" rel=\"noreferrer noopener\">disclosure statement<\/a> that warns a consumer if the product exceeds FDA limits for total fat, saturated fat, cholesterol, or sodium.<\/p>\n\n\n\n<p>The limits are:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fat \u2013 13g<\/li>\n\n\n\n<li>Saturated Fat \u2013 4g<\/li>\n\n\n\n<li>Cholesterol \u2013 60mg<\/li>\n\n\n\n<li>Sodium \u2013 480mg<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-deep-dive-high-potency-antioxidant-amp-percentage-claims\"><span class=\"ez-toc-section\" id=\"Deep_Dive_High_Potency_Antioxidant_Percentage_Claims\"><\/span>Deep Dive: High Potency, Antioxidant, &amp; Percentage Claims<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignright size-medium is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"200\" src=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-300x200.jpeg\" alt=\"Ginkgo leaves and a strainer\" class=\"wp-image-12285\" style=\"width:300px;height:auto\" srcset=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-300x200.jpeg 300w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1024x682.jpeg 1024w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-768x512.jpeg 768w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1536x1023.jpeg 1536w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-900x600.jpeg 900w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-645x430.jpeg 645w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-420x280.jpeg 420w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-318x212.jpeg 318w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-290x193.jpeg 290w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-630x420.jpeg 630w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-280x187.jpeg 280w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image.jpeg 1600w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\"><figcaption class=\"wp-element-caption\"><a href=\"https:\/\/www.pexels.com\/photo\/ginkgo-leaves-and-a-strainer-7615618\/\">Photo by Nataliya Vaitkevich<\/a><\/figcaption><\/figure>\n<\/div>\n\n\n<p>When it comes to nutrition content claims, for dietary supplements, such as potency, antioxidant, and percentage claims \u2013 it\u2019s vital that supplement manufacturers get them right. This is because these claims are considered to be more technical and have multiple layers and expectations to meet, on top of the general NCC rules.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-high-potency-claims-the-100-test\"><span class=\"ez-toc-section\" id=\"High_Potency_Claims_%E2%80%93_The_100_Test\"><\/span>High Potency Claims \u2013 The 100% Test<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>A supplement <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=%C2%A0Can%20I%20use%20the%20term%20%22high%20potency%22%20to%20describe%20an%20individual%20nutrient%3F\" target=\"_blank\" rel=\"noreferrer noopener\">can carry the High Potency Claim<\/a> if one individual nutrient is present at 100% or more of its Reference Daily Intake (RDI) per serving.\u00a0<\/p>\n\n\n\n<p>For combination products or botanicals, the claim is only allowed when the product clearly identifies which vitamin, or mineral, is being described. <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=%C2%A0Can%20the%20term%20%22high%20potency%22%20be%20used%20for%20combination%20products%2C%20such%20as%20botanicals%20with%20vitamins%3F\" target=\"_blank\" rel=\"noreferrer noopener\">For example:<\/a> \u201cBotanical X with high potency vitamin E\u201d.<\/p>\n\n\n\n<p>For a multinutrient supplement (i.e. multivitamins), \u201chigh potency\u201d can be claimed if the product contains 100% or more of the RDI for at least \u2154 of the nutrients listed. <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=%C2%A0How%20many%20nutrients%20must%20be%20present%20at%20100%25%20of%20the%20DV%20for%20a%20multinutrient%20product%20to%20qualify%20for%20the%20term%20%22high%20potency%3F%22\" target=\"_blank\" rel=\"noreferrer noopener\">For example:<\/a> \u201cHigh potency multivitamin, multimineral dietary supplement tablets\u201d<\/p>\n\n\n\n<p>The FDA strictly regulates \u201cHigh Potency\u201d because the term often implies a pharmacological effect \u2013 a direct, measurable change in the body\u2019s chemistry or function. If misused, these claims can be highly misleading or potentially encourage unsafe dosing. The strict, mathematical FDA standards exist solely to protect consumers and maintain trust.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-antioxidant-claims-nbsp-the-three-checks\"><span class=\"ez-toc-section\" id=\"Antioxidant_Claims_%E2%80%93_The_Three_Checks\"><\/span>Antioxidant Claims\u00a0 \u2013 The Three Checks<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>For the claim \u201cAntioxidant\u201d to be true and present,\u00a0 three points must be strictly followed:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>The nutrient must have an established RDI.<\/strong>\n<ul class=\"wp-block-list\">\n<li>The average daily intake of a nutrient recommended to meet the requirements of 97\u201398% of healthy individuals in a specific group.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=May%20beta%2Dcarotene%2C%20which%20does%20not%20have%20an%20RDI%2C%20be%20the%20subject%20of%20an%20antioxidant%20claim%3F%C2%A0\">One exception<\/a> to this rule is beta-carotene (which does not have an RDI). So, a claim of \u201cgood source of antioxidant in beta-carotene\u201d can be made when 10% or more of RDI for vitamin A is present as beta-carotene.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>It has recognized scientific antioxidant activity.<\/strong>\n<ul class=\"wp-block-list\">\n<li>As defined <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=and%20(g)(3)-,What%20do%20you%20mean%20by%20%22recognized%20antioxidant%20activity%22%3F,-Recognized%20antioxidant%20activity\" target=\"_blank\" rel=\"noreferrer noopener\">by the FDA<\/a>: The ingredient must be scientifically proven to maintain cell integrity by neutralizing free radicals once it is absorbed.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>The dose must qualify for a \u201cGood Source\u201d, \u201cHigh\u201d, or \u201cMore\u201d claim.<\/strong>\n<ul class=\"wp-block-list\">\n<li>In addition to having recognized antioxidant activity, each nutrient must qualify for either \u201chigh\u201d, \u201cgood source\u201d, or \u201cmore\u201d claims.\u00a0<\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=101.54(g)(1)-,Are%20there%20any%20other%20requirements%20for%20a%20dietary%20supplement%20to%20qualify%20for%20an%20antioxidant%20nutrient%20content%20claim%3F,-Yes.%20The%20nutrients\" target=\"_blank\" rel=\"noreferrer noopener\">For example:<\/a> \u201cHigh in antioxidant vitamin C\u201d means it must contain 20% or more of its RDI.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-31:~:text=101.54(g)(1)-,Are%20there%20any%20other%20requirements%20for%20a%20dietary%20supplement%20to%20qualify%20for%20an%20antioxidant%20nutrient%20content%20claim%3F,-Yes.%20The%20nutrients\" target=\"_blank\" rel=\"noreferrer noopener\">For example:<\/a> \u201cGood source of antioxidant vitamin C\u201d means it must contain 10-19% of its RDI.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>Just like the high potency claim, claiming a dietary supplement is an antioxidant could be misleading and harmful to consumers if overused. Therefore, the above strict guidelines are implemented to ensure the claim is only made when it passes the tough regulations.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-percentage-claims-nbsp-for-non-dv-ingredients\"><span class=\"ez-toc-section\" id=\"Percentage_Claims_%E2%80%93_For_Non-DV_Ingredients\"><\/span>Percentage Claims\u00a0 \u2013 For Non-DV Ingredients<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-34:~:text=%C2%A0What%20is%20a%20percentage%20claim%3F\" target=\"_blank\" rel=\"noreferrer noopener\">A percentage claim<\/a> is a statement used for a dietary ingredient that does not have an RDI, DRV, or established Daily Value (DV). If this statement is made, it must have a disclosure statement as well.<\/p>\n\n\n\n<p>There are 2 types of percentage claims:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-34:~:text=q)(3)(ii)-,What%20is%20a%20simple%20percentage%20claim%3F,-It%20is%20a\" target=\"_blank\" rel=\"noreferrer noopener\">Simple Percentage Claim:<\/a> The percentage of a non-DV ingredient can be added (e.g \u201c40% Curcuminoids\u201d), but it must immediately list the actual amount in milligrams next to it (e.g \u201c40% Curcuminoids, 200mg per capsule\u201d).<\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-34:~:text=3)(ii)(A)-,What%20is%20a%20comparative%20percentage%20claim%3F,-It%20is%20a\" target=\"_blank\" rel=\"noreferrer noopener\">Comparative Percentage Claim:<\/a> A non-DV ingredient can be compared to a reference product (e.g., \u201cTwice the Omega-3\u201d), but it must clearly identify the reference product and disclose the exact amount of the ingredient in both products.<\/li>\n<\/ol>\n\n\n\n<p>This rule is exclusive to dietary supplements, as they often have ingredients that do not have an established Daily Value (DV).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-differences-between-supplement-and-food-claims\"><span class=\"ez-toc-section\" id=\"Key_Differences_between_Supplement_and_Food_Claims\"><\/span>Key Differences between Supplement and Food Claims<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Labeling for conventional food versus supplements may seem similar in terms of the language used and the layout; however, there are some fundamental differences. A misstep in any compliance regulations for supplements could be very costly! This is why it\u2019s essential for food manufacturers to correctly choose a supplement labeling software that\u2019s knowledgeable and compliant.\u00a0<\/p>\n\n\n\n<p>The table below summarizes the key differences in labeling regulations between nutrition facts and supplement facts.<\/p>\n\n\n\n<figure class=\"wp-block-table flm-header\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Regulation<\/strong><\/td><td><strong>Conventional Food<\/strong><\/td><td><strong>Dietary Supplements<\/strong><\/td><\/tr><tr><td><strong>Disclaimer Requirement<\/strong><\/td><td>Not required when making S\/F claims<\/td><td>Always required when making S\/F claims according to the <a href=\"https:\/\/ods.od.nih.gov\/About\/DSHEA_Wording.aspx\" target=\"_blank\" rel=\"noreferrer noopener\">Dietary Supplement Health and Education Act (DSHEA) of 1994<\/a>.<\/td><\/tr><tr><td><strong>\u201cHealthy Claim\u201d<\/strong><\/td><td>Based on food groups (i.e. grains, fruits, vegetables) and limits \u2018bad\u2019 nutrients\u2019 (i.e. sodium, saturated foods)<\/td><td>Do not quality since nutrients are very concentrated.<\/td><\/tr><tr><td><strong>Nutrient Content Claims<\/strong><\/td><td>Usually used to showcase what has been removed (low fat, no added sugar)<\/td><td>Almost exclusively used to showcase what has been added (high potency, good source)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-final-check-scientific-evidence-is-required\"><span class=\"ez-toc-section\" id=\"Final_Check_Scientific_Evidence_is_Required\"><\/span>Final Check: Scientific Evidence is Required<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Compliance starts and ends with having scientific proof. Every single claim must be backed by competent and reliable scientific evidence kept, on file, by the manufacturer. If you are challenged by a regulator, this evidence is your only defense.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-1024x683.jpeg\" alt=\"Person holding laboratory flask.\" class=\"wp-image-12291\" srcset=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-1024x683.jpeg 1024w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-300x200.jpeg 300w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-768x513.jpeg 768w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-900x601.jpeg 900w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-645x430.jpeg 645w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-420x280.jpeg 420w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-318x212.jpeg 318w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-290x194.jpeg 290w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-630x420.jpeg 630w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1-280x187.jpeg 280w, https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/image-1-1536x1025-1.jpeg 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\"><figcaption class=\"wp-element-caption\"><a href=\"https:\/\/www.pexels.com\/photo\/person-holding-laboratory-flask-2280571\/\">Photo by Chokniti Khongchum<\/a><\/figcaption><\/figure>\n\n\n\n<p>While the FDA focuses primarily on the physical label and product packaging, the <a href=\"https:\/\/www.ftc.gov\/news-events\/news\/speeches\/ftc-dietary-supplements\" target=\"_blank\" rel=\"noreferrer noopener\">FTC (Federal Trade Commission)<\/a> monitors all forms of advertising (your website, social media posts, email marketing, etc.). Both agencies require the same level of scientific integrity for any claim you make, meaning your proof must be ready for review at all times.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-conclusion-fda-dietary-supplement-claims\"><span class=\"ez-toc-section\" id=\"Conclusion_FDA_Dietary_Supplement_Claims\"><\/span>Conclusion: FDA Dietary Supplement Claims<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>For any dietary supplement manufacturer, ensuring your label claims are FDA-compliant is a crucial legal step to get the supplement on shelves, legally.<\/p>\n\n\n\n<p>The primary insight is that every claim has a unique regulatory hurdle. Structure\/Function Claims demand two things: an FDA disclaimer and notification, and avoiding any language that suggests a cure. Health Claims are the most stringent, requiring extensive scientific evidence and mandatory pre-approval. Finally, NCCs such as \u201cHigh Potency\u201d are entirely dependent on precise calculation and meeting the FDA\u2019s strict quantitative standards.<\/p>\n\n\n\n<p>Ultimately, regardless of which claim you use, compliance starts and ends with having reliable scientific evidence on file to back up every statement. This proof must be ready for review by the FDA (for labeling) and the FTC (for advertising).<\/p>\n\n\n\n<p>To eliminate the risk of errors, <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">book a demo<\/a> to see how Food Label Maker automatically verifies your ingredient levels against all the FDA\u2019s strict regulations, guaranteeing a fully FDA-compliant label every time.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-frequently-asked-questions-nbsp\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions\"><\/span>Frequently Asked Questions\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-how-should-the-disclosure-statement-be-presented-on-my-supplements-label\"><span class=\"ez-toc-section\" id=\"1_How_should_the_disclosure_statement_be_presented_on_my_supplements_label\"><\/span>1. How should the disclosure statement be presented on my supplements label?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The supplements label disclosure statement must be presented in a specific, highly visible format when a nutrient content claim is made that exceeds levels for fat, saturated fat, cholesterol, or sodium (<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/part-101\/section-101.13#p-101.13(h)(4)\" target=\"_blank\" rel=\"noreferrer noopener\">21 CFR 101.13(h)(4)<\/a>).\u00a0<\/p>\n\n\n\n<p>The statement must have the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Correct wording: \u201cSee nutrition information for [nutrient] content\u201d (e.g., \u201cSee nutrition information for fat content\u201d).\u00a0<\/li>\n\n\n\n<li>Immediate placement next to the nutrient content claim with no intervening material (like text or graphics).<\/li>\n\n\n\n<li>Easily legible boldface print in distinct contrast to the rest of the label.<\/li>\n\n\n\n<li>Font size no less than half the font size of the main claim it is attached to.<\/li>\n<\/ul>\n\n\n\n<p>If you need help with your disclosure statement, <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">book a demo<\/a> with our team and one of our experts will guide you through any specific questions you may have.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-how-do-i-notify-the-fda-once-i-make-a-structure-function-claim-on-my-supplements-label\"><span class=\"ez-toc-section\" id=\"2_How_do_I_notify_the_FDA_once_I_make_a_structurefunction_claim_on_my_supplements_label\"><\/span>2. How do I notify the FDA once I make a structure\/function claim on my supplements label?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Once you have made relevant structure\/function claims on your supplement label, you should follow these steps, according to the <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements-guidance-documents-regulatory-information\/dietary-supplement-labeling-guide-chapter-vi-claims#6-49:~:text=%C2%A0What%20are%20the%20notification%20procedures%20for%20structure\/function%20claims%3F\" target=\"_blank\" rel=\"noreferrer noopener\">FDA regulations:<\/a><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Notify FDA within 30 days of first marketing a product whose label or labeling bears a statement made under section 403(r)(6) of the act;<\/li>\n\n\n\n<li>Submit an original and two copies of the notification to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835;<\/li>\n\n\n\n<li>The notification must be signed by a person who can certify that the information in the notification is complete and accurate, and that the notifying firm has substantiation that the section 403(r)(6) statement is truthful and not misleading.<\/li>\n<\/ol>\n\n\n\n<p>If you\u2019d prefer not to handle dietary supplement claims on your own, <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">book a demo with Food Label Maker<\/a>, and a dedicated account manager will be assigned to help you at every step.\u00a0<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_Who_is_Food_Label_Makers_Supplement_Labeling_Tool_designed_for\"><\/span>3. Who is Food Label Maker\u2019s Supplement Labeling Tool designed for?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>If you\u2019re a product developer, R&amp;D scientist, regulatory affairs specialist, quality assurance manager or a nutritionist \u2013 this supplements labeling software was designed with you in mind.<\/p>\n\n\n\n<p>The tool is designed in an accurate, compliant and user-friendly way for you to create FDA supplement facts labels with ease and reassurance that it complies with current regulations. It features automated formula builders for scientists, instant compliance verification for regulatory teams, and validation tools crucial for QA managers and nutritionists.<\/p>\n\n\n\n<p><a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">Book a demo<\/a> today to learn more.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-4-how-does-the-food-label-maker-software-stay-compliant-with-changing-fda-regulations\"><span class=\"ez-toc-section\" id=\"4_How_does_the_Food_Label_Maker_software_stay_compliant_with_changing_FDA_regulations\"><\/span>4. How does the Food Label Maker software stay compliant with changing FDA regulations?<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>We\u2019re always tracking regulatory changes and are constantly updating our software so that your Supplement Facts Label is compliant. Details like formatting changes to new nutrient disclosures are continuously updated so your labels stay compliant by default, reducing the risk of errors or recalls.<\/p>\n\n\n\n<p>To learn more about our Supplements Labeling Software, <a href=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/supplement-submission-form\/\">book a demo today.\u00a0<\/a><\/p>\n\n\n\n<style>\n.flm-header table tr:first-child td {\n\tcolor: white;\n\tbackground-color: #347362;\n\tborder-color: #000!important;\n\tpadding: 15px!important;\n\ttext-align: center;\n}\n\n.recipal-header table tr:first-child td {\n\tcolor: white;\n\tbackground-color: #408abf;\n\tborder-color: #000!important;\n\tpadding: 15px!important;\n\ttext-align: center;\n}\n<\/style>\n","protected":false},"author":5,"featured_media":12298,"parent":0,"template":"","meta":{"_acf_changed":true},"regulatory-category":[341],"class_list":["post-17070","regulatory-hub","type-regulatory-hub","status-publish","has-post-thumbnail","hentry","regulatory-category-dietary-supplements"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>How to Make FDA Dietary Supplement Claims | Food Label Maker<\/title>\n<meta name=\"description\" content=\"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Make FDA-Compliant Dietary Supplement Claims\" \/>\n<meta property=\"og:description\" content=\"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\" \/>\n<meta property=\"og:site_name\" content=\"Food Label Maker\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/foodlabelmaker\/\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"700\" \/>\n\t<meta property=\"og:image:height\" content=\"602\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"13 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\"},\"author\":{\"name\":\"Maria Abi Hanna\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/c20e7f4fb1971c18a92723e05a9fbcc2\"},\"headline\":\"How to Make FDA-Compliant Dietary Supplement Claims\",\"datePublished\":\"2025-11-06T19:46:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\"},\"wordCount\":2632,\"image\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg\",\"inLanguage\":\"en-CA\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\",\"url\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\",\"name\":\"How to Make FDA Dietary Supplement Claims | Food Label Maker\",\"isPartOf\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg\",\"datePublished\":\"2025-11-06T19:46:25+00:00\",\"description\":\"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.\",\"breadcrumb\":{\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#breadcrumb\"},\"inLanguage\":\"en-CA\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-CA\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage\",\"url\":\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg\",\"contentUrl\":\"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg\",\"width\":700,\"height\":602},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Regulatory Hub\",\"item\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"How to Make FDA-Compliant Dietary Supplement Claims\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#website\",\"url\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/\",\"name\":\"Food Label Maker\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-CA\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/c20e7f4fb1971c18a92723e05a9fbcc2\",\"name\":\"Maria Abi Hanna\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-CA\",\"@id\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b1c95c3da7399da107239bf96890a5fd3062930535e58f727a8968f38a191c6f?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b1c95c3da7399da107239bf96890a5fd3062930535e58f727a8968f38a191c6f?s=96&d=mm&r=g\",\"caption\":\"Maria Abi Hanna\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/in\/maria-abi-hanna-2b6770b3\/\"],\"url\":\"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/blog\/author\/maria\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to Make FDA Dietary Supplement Claims | Food Label Maker","description":"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"en_US","og_type":"article","og_title":"How to Make FDA-Compliant Dietary Supplement Claims","og_description":"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.","og_url":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/","og_site_name":"Food Label Maker","article_publisher":"https:\/\/www.facebook.com\/foodlabelmaker\/","og_image":[{"width":700,"height":602,"url":"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"13 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#article","isPartOf":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/"},"author":{"name":"Maria Abi Hanna","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/c20e7f4fb1971c18a92723e05a9fbcc2"},"headline":"How to Make FDA-Compliant Dietary Supplement Claims","datePublished":"2025-11-06T19:46:25+00:00","mainEntityOfPage":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/"},"wordCount":2632,"image":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage"},"thumbnailUrl":"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg","inLanguage":"en-CA"},{"@type":"WebPage","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/","url":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/","name":"How to Make FDA Dietary Supplement Claims | Food Label Maker","isPartOf":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage"},"image":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage"},"thumbnailUrl":"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg","datePublished":"2025-11-06T19:46:25+00:00","description":"Master FDA dietary supplement claims for accurate, compliant, and comprehensive Supplement Facts labels. Read on Food Label Maker today.","breadcrumb":{"@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#breadcrumb"},"inLanguage":"en-CA","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/"]}]},{"@type":"ImageObject","inLanguage":"en-CA","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#primaryimage","url":"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg","contentUrl":"https:\/\/flmdev.dev1.symbiotica.rs\/wp-content\/uploads\/2025\/11\/tueorit2342.jpg","width":700,"height":602},{"@type":"BreadcrumbList","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/fda\/dietary-supplements\/fda-dietary-supplement-claims\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/"},{"@type":"ListItem","position":2,"name":"Regulatory Hub","item":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/regulatory-hub\/"},{"@type":"ListItem","position":3,"name":"How to Make FDA-Compliant Dietary Supplement Claims"}]},{"@type":"WebSite","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#website","url":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/","name":"Food Label Maker","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-CA"},{"@type":"Person","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/c20e7f4fb1971c18a92723e05a9fbcc2","name":"Maria Abi Hanna","image":{"@type":"ImageObject","inLanguage":"en-CA","@id":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b1c95c3da7399da107239bf96890a5fd3062930535e58f727a8968f38a191c6f?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b1c95c3da7399da107239bf96890a5fd3062930535e58f727a8968f38a191c6f?s=96&d=mm&r=g","caption":"Maria Abi Hanna"},"sameAs":["https:\/\/www.linkedin.com\/in\/maria-abi-hanna-2b6770b3\/"],"url":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/blog\/author\/maria\/"}]}},"_links":{"self":[{"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/regulatory-hub\/17070","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/regulatory-hub"}],"about":[{"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/types\/regulatory-hub"}],"author":[{"embeddable":true,"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/users\/5"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/media\/12298"}],"wp:attachment":[{"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/media?parent=17070"}],"wp:term":[{"taxonomy":"regulatory-category","embeddable":true,"href":"https:\/\/flmdev.dev1.symbiotica.rs\/en-ca\/wp-json\/wp\/v2\/regulatory-category?post=17070"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}