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U.S. Department of Health and Human Services

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Dietary Supplement Labeling Guide: Chapter I. General Dietary Supplement Labeling

April 2005

Guidance for Industry
A Dietary Supplement Labeling Guide

Contains Nonbinding Recommendations

This document also available en Espanol (Spanish).


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Questions

  1. How are dietary supplements defined?
  2. What label statements are required on the containers and packages of dietary supplements?
  3. Where do I place the required label statements?
  4. What label statements must I place on the principal display panel?
  5. How do I locate the principal display panel?
  6. What label statements must I place on the information panel?
  7. Where is the information panel?
  8. What name and address must I list on the label of my product?
  9. May I place intervening material on the information panel?
  10. What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?
  11. Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?
  12. Who regulates the statement "Made in the U.S.A."?
  13. How do I obtain a UPC bar code?
  14. Must expiration dating be included on the label for dietary supplements?

Answers

  1.  How are dietary supplements defined?

    Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:

    1. A vitamin;
    2. A mineral;
    3. An herb or other botanical;
    4. An amino acid;
    5. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
    6. A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.

    Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements. The complete statutory definition is found in section 201(ff) of Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321).

  2.  What label statements are required on the containers and packages of dietary supplements?

    Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.

    21 CFR 101.3(a), 21 CFR 101.105(a), 21 CFR 101.36, 21 CFR 101.4(a)(1), and 21 CFR 101.5

  3.  Where do I place the required label statements?

    You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).

    21 CFR 101.2(b) and (d), 21 CFR 101.9(j)(13) and (j)(17), 21 CFR 101.36(g), (i)(2) and (i)(5)

  4.  What label statements must I place on the principal display panel?

    You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.

    21 CFR 101.1, 21 CFR 101.3(a) and 21 CFR 101.105(a)

  5.  How do I locate the principal display panel?

    The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.

    21 CFR 101.1

  6.  What label statements must I place on the information panel?

    You must place the "Supplement Facts" panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the "Supplement Facts" panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.

    21 CFR 101.2(b) and (d), 101.36(i)(2)(iii) and (i)(5), 101.5, 101.9(j)(13)(i)(A) and (j)(17)

  7.  Where is the information panel?

    The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.

    21 CFR 101.2(a)

  8.  What name and address must I list on the label of my product?

    You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.

    21 CFR 101.5

  9.  May I place intervening material on the information panel?

    No. You may not place intervening material, which is defined as label information that is not required (e.g., UPC bar code), between label information that is required on the information panel.

    21 CFR 101.2(e)

  10.  What type size, prominence and conspicuousness am I required to use on the principal display panel and the information panel?

    You are required to use a print or type size that is prominent, conspicuous and easy to read. The letters must be at least one-sixteenth (1/16) inch in height based on the lower case letter "o," and not be more than three times as high as they are wide, unless you petition for an exemption in accordance with 21 CFR 101.2(f). The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. See Chapter IV for the type size requirements for the nutrition label.

    21 CFR 101.2(c) and (f), 21 CFR 101.15, and 21 CFR 101.105(h)

  11.  Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?

    Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.

    Section 304, Tariff Act of 1930, as amended (19 U.S.C. 304)

  12.  Who regulates the statement "Made in the U. S. A."? 

    FDA does not have regulatory authority over such statements. The U.S. Customs Service regulates country of origin marking (i.e., "Made in the U.S.A.") as authorized by the Tariff Act of 1930. Their website is www.customs.ustreas.gov.

  13.  How do I obtain a UPC bar code?

    The UPC bar code may be obtained from the Uniform Code Council. Their website is www.uc-council.org. Click on the button that says "I Need a UPC Bar Code."

  14.  Must expiration dating be included on the label of dietary supplements?

    No. However, a firm may include this information if it is supported by valid data demonstrating that it is not false or misleading.