Dietary Supplement Labeling Guide

April 2005

Contains Nonbinding Recommendations.

This document also available en Español (Spanish).

Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to All comments should be identified with the Docket Number 2004D-0487.

For questions regarding this document contact the Center for Food Safety and Applied Nutrition, at 240-402-2375.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.


The Food and Drug Administration (FDA) receives many questions about the labeling of dietary supplements. These questions are a consequence of the activity in this area over the past several years. Some of the important events relating to the labeling of dietary supplements include:

  • The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.
  • The Dietary Supplement Health and Education Act of 1994 (the DSHEA) amended the act, in part, by defining "dietary supplements," adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.
  • On September 23, 1997 (62 FR 49826), we implemented the DSHEA by publishing several key regulations on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. On June 5, 1998 (63 FR 30615), we amended the regulations pertaining to the nutrition labeling of extracts used in dietary supplements.
  • On January 15, 1997 (62 FR 2218), we published regulations that require a label warning statement on dietary supplements with added iron. These regulations also required the unit-dose packaging of supplements containing 30 milligrams or more, but this requirement has been eliminated as a result of a court challenge in January, 2003.
  • On July 11, 2003 (68 FR 41434), we published a final regulation that amended the labeling requirements for dietary supplements, as well as for conventional foods, that would make the declaration of trans fat mandatory in nutrition labeling. This regulation requires that, when present at 0.5 g or more, trans fat be listed in the Supplement Facts panel of dietary supplements on a separate line under the listing of saturated fat by January 1, 2006.

We have prepared this guide to help assure that the dietary supplements sold in the United Stated (U.S.) are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries. Under our regulations, label approval is not required to import or distribute a dietary supplement.

We have included the most frequently raised questions about the labeling of dietary supplements using a "question and answer" format. If you have a question not addressed in this guide, please contact an FDA District Office (see Appendix A of this guide) or the:

Division of Dietary Supplement Programs (HFS-810)
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
(301) 436-2375 (Updated phone: 240-402-2375)

Please be advised that you must comply with any requirements for dietary supplements that may publish after this booklet is issued. New regulations are published in the Federal Register prior to their effective date and are compiled annually in Title 21, Part 101 of the Code of Federal Regulations (21 CFR 101). Summaries of our new regulations (proposed regulations and final regulations) are posted on our Internet Website (

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required.

April 2005

Table of Contents
  1. General Dietary Supplement Labeling
  2. Identity Statement
  3. Net Quantity of Contents
  4. Nutrition Labeling
  5. Ingredient Labeling
  6. Claims
  7. Pre-market Notification of New Dietary Ingredients
  8. Other Labeling Information
  1. FDA District Offices
  2. Daily Values for Adults and Children 4 or More Years of Age (also known as Food Labeling Guide Reference Values)
  3. Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant or Lactating Women
  4. Nutrient Content Claims (Includes Food Labeling Guide Appendix A and B)
  5. Authorized Health Claims (Includes Food Labeling Guide Appendix C and FDAMA claims)
  6. Qualified Health Claims
Alternate principal display panelChapter I
"And/or" labeling of fat and oil ingredientsChapter V
Antioxidant claimsChapter VI
Artificial colorsChapter V
Artificial flavorsChapter V
BotanicalsChapter IV
Bulk containersChapter IV
Chemical preservativesChapter V
Common or usual nameChapters II and V
ConspicuousnessChapters I and III
Country of originChapter I
Daily ValuesChapter IV
Definition of dietary supplementsChapter I
Degree of ProminenceChapter I and II
Descending order of predominanceChapter IV and V
Determining the net quantityChapter III
Dietary ingredientsChapters I, II,IV, V, VI and VII
Different package sizesChapter III
DisclaimerChapter VI
Disclosure statementsChapter VI
Exemptions from nutrition labelingChapter IV
Expiration datingChapter I
ExtractsChapter IV
Folic acidChapter VIII
Format of "Supplement Facts" panelChapter IV
"Free" claimsChapter VI
"Good source" claimsChapter VI
Health claimsChapter VI
"High potency" claimsChapter VI
Incidental additivesChapter V
Information panelChapter I
Ingredient listChapter V
Iron-containing dietary supplementsChapter VIII
JuiceChapter VIII
Label statementsChapter I
Latin namesChapter IV
Name and addressChapter I
"Low" claimsChapter VI
Name of dietary supplementChapter II
Natural flavorsChapter V
Net quantity of contents statementChapter III
New dietary ingredientChapter VII
New dietary supplementsChapter VII
NomenclatureChapter IV
Notification for a claimChapter VI
Nutrient content claimsChapter VI
Nutrition labelingChapter IV
Nutrition labeling exemptionsChapter IV
Omega-3 fatty acidsChapter VI
OrganicChapter VIII
Other dietary ingredientsChapter IV
Ounces and gramsChapter III
Percent of Daily ValueChapter IV
Percentage claimsChapter VI
Placement of statement of identityChapter II
Premarket notificationChapter VII
Principal display panelChapter I and III
ProminenceChapters I
Proprietary blendsChapter IV
Section 403(r)(6) claimsChapter VI
Serving sizesChapter IV
Small packagesChapter IV
Special labeling provisionsChapter VI
Statement of identityChapter II
Structure/function claimsChapter VI
"Supplement Facts"Chapter IV
Trans fatChapter IV
Type sizeChapters I - VI
Warning statement about ironChapter VI
WaterChapter V

(1) This guidance has been prepared by the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) in the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration.


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