Guidance for Industry

A Dietary Supplement Labeling Guide

Contains Nonbinding Recommendations.

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 http://www.fda.gov/dockets/ecomments. All comments should be identified with the Docket Number 2004D-0487.

For questions regarding this document contact Susan Thompson at the Center for Food Safety and Applied Nutrition, (Tel) 301 436-1784, (Fax) 301 436-2639, or e-mail Susan Thompson at

Additional copies are available from:
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition, HFS-810
Food and Drug Administration, 5100 Paint Branch Parkway
College Park, MD 20740
http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
April 2005

---

Guidance for Industry⁽¹⁾

A Dietary Supplement Labeling Guide

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. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Introduction

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
5100 Paint Branch Parkway
College Park, MD 20740-3835
(301) 436-2375

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 (http://www.fda.gov).

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. Statement of Identity
3. Net Quantity of Contents
4. Nutrition Labeling
5. Ingredient Labeling
6. Claims
7. Premarket Notification of New Dietary Ingredients
8. Other Labeling Information

Appendixes

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

Index

---

Index

Alternate principal display panel	Chapter I
"And/or" labeling of fat and oil ingredients	Chapter V
Antioxidant claims	Chapter VI
Artificial colors	Chapter V
Artificial flavors	Chapter V
Botanicals	Chapter IV
Bulk containers	Chapter IV
Chemical preservatives	Chapter V
Common or usual name	Chapters II and V
Conspicuousness	Chapters I and III
Country of origin	Chapter I
Daily Values	Chapter IV
Definition of dietary supplements	Chapter I
Degree of Prominence	Chapter I and II
Descending order of predominance	Chapter IV and V
Determining the net quantity	Chapter III
Dietary ingredients	Chapters I, II,IV, V, VI and VII
Different package sizes	Chapter III
Disclaimer	Chapter VI
Disclosure statements	Chapter VI
Exemptions from nutrition labeling	Chapter IV
Expiration dating	Chapter I
Extracts	Chapter IV
Folic acid	Chapter VIII
Format of "Supplement Facts" panel	Chapter IV
"Free" claims	Chapter VI
"Good source" claims	Chapter VI
Health claims	Chapter VI
"High potency" claims	Chapter VI
Incidental additives	Chapter V
Information panel	Chapter I
Ingredient list	Chapter V
Iron-containing dietary supplements	Chapter VIII
Juice	Chapter VIII
Label statements	Chapter I
Latin names	Chapter IV
Name and address	Chapter I
"Low" claims	Chapter VI
Name of dietary supplement	Chapter II
Natural flavors	Chapter V
Net quantity of contents statement	Chapter III
New dietary ingredient	Chapter VII
New dietary supplements	Chapter VII
Nomenclature	Chapter IV
Notification for a claim	Chapter VI
Nutrient content claims	Chapter VI
Nutrition labeling	Chapter IV
Nutrition labeling exemptions	Chapter IV
Omega-3 fatty acids	Chapter VI
Organic	Chapter VIII
Other dietary ingredients	Chapter IV
Ounces and grams	Chapter III
Percent of Daily Value	Chapter IV
Percentage claims	Chapter VI
Placement of statement of identity	Chapter II
Premarket notification	Chapter VII
Principal display panel	Chapter I and III
Prominence	Chapters I
Proprietary blends	Chapter IV
Section 403(r)(6) claims	Chapter VI
Serving sizes	Chapter IV
Small packages	Chapter IV
Special labeling provisions	Chapter VI
Statement of identity	Chapter II
Structure/function claims	Chapter VI
"Supplement Facts"	Chapter IV
Trans fat	Chapter IV
Type size	Chapters I - VI
Warning statement about iron	Chapter VI
Water	Chapter 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.