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U.S. Department of Health and Human Services

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Dietary Supplement Labeling Guide: Chapter V. Ingredient Labeling

April 2005

Guidance for Industry
A Dietary Supplement Labeling Guide

Contains Nonbinding Recommendations

This document also available en Español (Spanish).

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Questions

  1. What is an "ingredient"?
  2. What is unique about the ingredient labeling of dietary supplements?
  3. Do I need an ingredient statement when all of my ingredients are listed in the "Supplement Facts" panel?
  4. How must I identify the ingredient list?
  5. Where must I place the ingredient list on the label?
  6. What type size must I use for the ingredient list?
  7. Must I list the ingredients in a specified order?
  8. How must I declare spices, natural flavors, or artificial flavors?
  9. Can I indicate that a spice is also a coloring?
  10. How must I declare artificial colors?
  11. May I use "and/or" labeling for fats and oils?
  12. Do I need to list water?
  13. How do I list a chemical preservative?

Answers

  1.  What is an "ingredient"?

    The Dietary Supplement Health and Education Act uses the term "ingredient" to refer to the compounds used in the manufacture of a dietary supplement. For instance, when calcium carbonate is used to provide calcium, calcium carbonate is an "ingredient" and calcium is a "dietary ingredient." The term "ingredient" also refers to substances such as binders, colors, excipients, fillers, flavors, and sweeteners.

    Public Law 103-417, 60 Federal Register 67194 at 67199 (December 28, 1995)

  2.  What is unique about the ingredient labeling of dietary supplements?

    Ingredients that are sources of dietary ingredients may be listed within the "Supplement Facts" panel, e.g., "Calcium (as calcium carbonate)." When ingredients are listed in this way, they do not have to be listed again in the ingredient statement (also called an ingredient list).

    21 CFR 101.36(d)

  3.  Do I need an ingredient statement when all of my ingredients are listed in the "Supplement Facts" panel?

    No. If you place all source ingredients in the "Supplement Facts" panel and you have no other ingredients, such as excipients or fillers, you do not need an ingredient statement.

    21 CFR 101.4(a)(1)

  4.  How must I identify the ingredient list?

    You must precede the ingredient list by the word "Ingredients," except that you must use the words "Other Ingredients" when you have identified some ingredients (i.e., as sources) within the nutrition label.

    21 CFR 101.4(g)

  5.  Where must I place the ingredient list on the label?

    When present, you must place the ingredient list on dietary supplements immediately below the nutrition label, or if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label.

    21 CFR 101.4(g)

  6.  What type size must I use for the ingredient list?

    You must display this information prominently and conspicuously, but in no case may the types size be less that 1/16 inch in height as measured by the lower case "o", or its equivalent, in accordance with 21 CFR 101.105(h)(2).

    21 CFR 101.2(c), 21 CFR 101.15, and 21 CFR 101.105(h)(1) and (2)

  7.  Must I list the ingredients in a specified order?

    Yes. You must list the ingredients in descending order of predominance by weight. This means that the ingredient that weighs the most is first and the ingredient that weighs the least is last.

    21 CFR 101.4(a)

  8.  How must I declare spices, natural flavors, or artificial flavors?

    You must declare these ingredients in ingredient lists by using either specific common or usual names or by using the declarations "spice," "natural flavor" or "artificial flavor," or any combination thereof.

    21 CFR 101.22(h)(1) and 21 CFR 101.4(a)(1)

  9.  Can I indicate that a spice is also a coloring?

    Yes. Paprika, turmeric, saffron and other spices that are also colorings, may be declared either by name or the term "spice and coloring." For example, paprika may be listed as "paprika" or as "spice and coloring."

    21 CFR 101.22(a)(2)

  10.  How must I declare artificial colors?

    It depends on whether or not the artificial color is certified. List a certified color by its specific or abbreviated name, e.g., "FD&C Red No. 40" or "Red 40."

    A color that is not certified may be listed as an "Artificial Color," "Artificial Color Added," "Color Added,"or by its specific common or usual name.

    21 CFR 101.22(k)(1) and (k)(2)

  11.  May I use "and/or" labeling for fats and oils?

    Yes. When a blend of fats and/or oils is not the predominant ingredient of your product and you vary the makeup of the blend you may use "and/or" labeling or language such as:

    INGREDIENTS:...vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)."

    21 CFR 101.4(b)(14)

  12.  Do I need to list water?

    Yes. You must identify the added water in the list of ingredients in descending order of predominance by weight. For example:

    "Ingredients: Cod liver oil, gelatin, water, and glycerin"

    21 CFR 101.4(a) and (c) and 21 CFR 101.36(e)(10)(iv)

  13.  How do I list a chemical preservative?

    You must list the common or usual name of the preservative followed by a description that explains its function e.g., "preservative," "to retard spoilage," "a mold inhibitor," "to help protect flavor," or "to promote color retention."

    21 CFR 101.22(j)