Guidance for Industry

A Dietary Supplement Labeling Guide

Chapter II. Statement of Identity

Contains Nonbinding Recommendations.

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 its common or usual name or an appropriately descriptive term, as specified by Federal law or regulation. You must place the statement of identity on the principal display panel and on alternate principal display panels, if present.

   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 use of the term "dietary supplement" as part of 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 CFR 101.3(g)

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

   No. This term by itself is not appropriately descriptive to be a statement of identity.

   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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