food in response to a court decision4 that was based on First Amendment commercial free speech considerations for dietary supplement labeling.

More recently FDA issued guidance on the review process for qualified health claims as part of its initiative on Consumer Health Information for Better Nutrition. The guidance included an interim method to systematically evaluate and rank the scientific evidence for qualified health claims (FDA, 2003c). While health claims are not addressed in this report, the committee’s recommendations may inform the process of developing health claims in so far as they relate to reference nutrient values.

Dietary Supplement5Labeling

NLEA covered dietary supplements, but as described earlier, DSA prohibited implementation of NLEA for dietary supplements earlier than December 15, 1993. Thus the 1993 nutrition labeling regulations did not address labeling of dietary supplements. However, as part of the implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) (21 U.S.C. §401(q)(5)), in 1997 FDA issued final regulations requiring that a Supplement Facts box appear on all dietary supplements effective in 1999 (FDA, 1997). The Supplement Facts box (see Box 2-3) is modeled after the Nutrition Fact box and is similarly regulated in content and format. It must include amounts and % DV of the same nutrients that are required on nutrition labeling of conventional food if the nutrients are present in the supplement and the amounts of other dietary ingredients included. These other dietary ingredients must be identified by their common or usual name and, in some cases for botanicals, by their Latin binomial name and specific plant part, if applicable.6 Proprietary blends may be listed by weight of the total blend,

4  

Pearson v. Shalala 164 F.3d 650 (D.C. Cir. 1999).

5  

Dietary supplements, as defined by DSHEA, include products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical; an amino acid; a dietary substance used to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above. A dietary supplement must be intended for ingestion in the form of a capsule, powder, soft gel, or gel cap, or, if not in one of those forms, is not represented as a conventional food or as a sole item of a meal or the diet (21 U.S.C. §321(ff).

6  

In a direct final rule FDA (2003a) amended its regulation on botanical ingredients in dietary supplements to incorporate the use of the latest (year 2000) editions



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