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CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements
April 2005
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
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.
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:
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
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.