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                Dietary Supplements Guidance Documents & Regulatory Information

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          Dietary Supplements Guidance Documents & Regulatory Information
          Dietary Supplement Labeling GuideDietary Supplements Guidance Documents & Regulatory Information Dietary Supplement Labeling Guide
  
  	
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    Print**April 2005**

*Contains Nonbinding Recommendations.*

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. 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.*

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
5001 Campus Drive
College Park, MD 20740-3835
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 (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

General Dietary Supplement Labeling
	Identity Statement
	Net Quantity of Contents
	Nutrition Labeling
	Ingredient Labeling
	Claims
	Pre-market Notification of New Dietary Ingredients
	Other Labeling InformationAppendixes

FDA District Offices
	Daily Values for Adults and Children 4 or More Years of Age (also known as Food Labeling Guide Reference Values)
	Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant or Lactating Women
	Nutrient Content Claims (Includes Food Labeling Guide Appendix A and B)
	Authorized Health Claims (Includes Food Labeling Guide Appendix C and FDAMA claims)
	Qualified Health ClaimsIndex
	Alternate principal display panel
			Chapter I"And/or" labeling of fat and oil ingredients
			Chapter VAntioxidant claims
			Chapter VIArtificial colors
			Chapter VArtificial flavors
			Chapter VBotanicals
			Chapter IVBulk containers
			Chapter IVChemical preservatives
			Chapter VCommon or usual name
			Chapters II and VConspicuousness
			Chapters I and IIICountry of origin
			Chapter IDaily Values
			Chapter IVDefinition of dietary supplements
			Chapter IDegree of Prominence
			Chapter I and IIDescending order of predominance
			Chapter IV and VDetermining the net quantity
			Chapter IIIDietary ingredients
			Chapters I, II,IV, V, VI and VIIDifferent package sizes
			Chapter IIIDisclaimer
			Chapter VIDisclosure statements
			Chapter VIExemptions from nutrition labeling
			Chapter IVExpiration dating
			Chapter IExtracts
			Chapter IVFolic acid
			Chapter VIIIFormat of "Supplement Facts" panel
			Chapter IV"Free" claims
			Chapter VI"Good source" claims
			Chapter VIHealth claims
			Chapter VI"High potency" claims
			Chapter VIIncidental additives
			Chapter VInformation panel
			Chapter IIngredient list
			Chapter VIron-containing dietary supplements
			Chapter VIIIJuice
			Chapter VIIILabel statements
			Chapter ILatin names
			Chapter IVName and address
			Chapter I"Low" claims
			Chapter VIName of dietary supplement
			Chapter IINatural flavors
			Chapter VNet quantity of contents statement
			Chapter IIINew dietary ingredient
			Chapter VIINew dietary supplements
			Chapter VIINomenclature
			Chapter IVNotification for a claim
			Chapter VINutrient content claims
			Chapter VINutrition labeling
			Chapter IVNutrition labeling exemptions
			Chapter IVOmega-3 fatty acids
			Chapter VIOrganic
			Chapter VIIIOther dietary ingredients
			Chapter IVOunces and grams
			Chapter IIIPercent of Daily Value
			Chapter IVPercentage claims
			Chapter VIPlacement of statement of identity
			Chapter IIPremarket notification
			Chapter VIIPrincipal display panel
			Chapter I and IIIProminence
			Chapters IProprietary blends
			Chapter IVSection 403(r)(6) claims
			Chapter VIServing sizes
			Chapter IVSmall packages
			Chapter IVSpecial labeling provisions
			Chapter VIStatement of identity
			Chapter IIStructure/function claims
			Chapter VI"Supplement Facts"
			Chapter IV*Trans* fat
			Chapter IVType size
			Chapters I - VIWarning statement about iron
			Chapter VIWater
			Chapter V

                                                                                  Content current as of:
      04/01/2005
              
              
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		 Dietary SupplementsDietary Supplements Guidance Documents & Regulatory Information
 
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