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  6. Dietary Supplement Labeling Guide: Chapter II. Identity Statement
  1. Dietary Supplements Guidance Documents & Regulatory Information

Dietary Supplement Labeling Guide: Chapter II. Identity Statement

January 2016

Contains Nonbinding Recommendations

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Questions

  1. What is the statement of identity for a dietary supplement and where must I place it?
  2. How am I required to identify a dietary supplement?
  3. Can the term "dietary supplement" by itself be considered the statement of identity?
  4. Should I make the statement of identity stand out?
  5. How should I place the statement of identity on the principal display panel?

Answers

1. What is the statement of identity for a dietary supplement and where must I place it?

The statement of identity for a dietary supplement is the name that appears on the label of the dietary supplement. As a general matter, the statement of identity of a food (including dietary supplements) is the name specified by federal law or regulation, or, if no such name is specified, the common or usual name of the food. If the food has no common or usual name and the nature of the food is not obvious, the statement of identity must be an appropriately descriptive term. In the case of dietary supplements, both the Federal Food, Drug, and Cosmetic Act and FDA’s regulations specify that the statement of identity must include the term “dietary supplement,” except that the word “dietary” may be replaced with a description of the type of dietary ingredient(s) in the product (e.g., “herbal supplement”) or the names of one or more dietary ingredients in the product (e.g., “bee pollen supplement”). You must place the statement of identity on the principal display panel of the dietary supplement and on any alternate principal display panels. Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity.

21 U.S.C. 321(ff)(2)(C), 21 U.S.C. 343(s)(2)(B), 21 CFR 101.1 and 21 CFR 101.3

2. How am I required to identify a dietary supplement?

You must identify a dietary supplement by using the term "dietary supplement" in the statement of identity, except that you may delete the word "dietary" and replace it with the name of the dietary ingredient(s) in the product (e.g., “calcium supplement”) or an appropriately descriptive term indicating the type of dietary ingredient(s) in your dietary supplement product (e.g., “herbal supplement with vitamins”).

21 U.S.C. 321(ff)(2)(C), 21 U.S.C. 343(s)(2)(B) and 21 CFR 101.3(g)

3. Can the term "dietary supplement" by itself be considered the statement of identity?

Yes. This term describes the basic nature of a dietary supplement and therefore is an “appropriately descriptive term” that can be used as the product’s statement of identity. The statement of identity for a dietary supplement may therefore consist simply of the term “dietary supplement,” or “dietary supplement” may be part of a longer statement of identity (e.g., “cod liver oil liquid dietary supplement”). In either case, the word ‘‘dietary’’ may be deleted and replaced by another appropriately descriptive term identifying the contents of the product, such as “calcium supplement,” “herbal supplement”, or “herbal supplement with vitamins.”

21 CFR 101.3(g)

4. Should I make the statement of identity stand out?

Yes. You must make the statement of identity one of the most important features on the principal display panel. To do this, you must use bold type and a type size reasonably related to the most prominent printed matter on the front panel of your label.

21 CFR 101.3(d) 

5. How should I place the statement of identity on the principal display panel?

You must place the statement of identity of your dietary supplement product in lines generally parallel to the base of the package.

21 CFR 101.3(d)  

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