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“Dietary Supplement” is a Proper Statement of Identity

FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement.  Announcement of this revision was published in a Federal Register notice on March 7th.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended section 403 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide that a dietary supplement would be deemed to be misbranded:

If … the label or labeling of the dietary supplement fails to identify the product by using the term “dietary supplement,” which term may be modified with the name of [a dietary] ingredient…

FFDCA § 403(s)(2)(B); 21 U.S.C. § 343(s)(2)(B).  The regulation promulgated by FDA to implement this statutory requirement provides:

Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins).

21 C.F.R. § 101.3(g).

In April 2005, FDA issued guidance for industry entitled “A Dietary Supplement Labeling Guide.”  In Chapter II, entitled “Identity Statement,” question 3 asked “Can the term ‘dietary supplement’ by itself be considered the statement of identity?”  The response to the question said that it could not; however, that response FDA now acknowledges was not consistent with FFDCA § 403(s)(2)(B) and 21 C.F.R. § 101.3(g). 

The revised question and answer (Q&A) now reads:

  1. 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.”

Dietary Supplement Labeling Guide: Chapter II. Identity Statement at Q&A 3.  FDA also has modified Q&As 2-3 for clarity and consistency with 21 CFR § 101.3(g).  The bottom line: “Dietary Supplement” is an acceptable statement of identity for a dietary supplement.

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