Page:United States Statutes at Large Volume 108 Part 5.djvu/840

 108 STAT. 4330 PUBLIC LAW 103-417—OCT. 25, 1994 "(1) it is a dietary supplement; and "(2)(A) the label or labeling of the supplement fails to list^ "(i) the name of each ingredient of the supplement that is described in section 201(fD; and "(ii)(I) the quantity of each such ingredient; or "(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend; "(B) 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 such an ingredient; "(C) the supplement contains an ingredient described in section 201(fO(l)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived; "(D) the supplement— "(i) is covered by the specifications of an official compendium; "(ii) is represented as conforming to the specifications of an official compendium; and "(iii) fails to so conform; or "(E) the supplement— "(i) is not covered by the specifications of an official compendium; and "(ii)(I) fails to have the identity and strength that the supplement is represented to have; or "(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.". (b) SUPPLEMENT LISTING ON NUTRITION LABELING.— Section 403(q)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended to read as follows: " (F) A dietgiry supplement product (including a food to which section 411 applies) shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the product and which is specified in regulations of the Secretary which shall provide that— "(i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established by the Secretary, except that a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation; "(ii) the listing of dietsiry ingredients shall include the quantity of each such ingrechent (or of a proprietary blend of such ingredients) per serving; "(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and "(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.". (c) PERCENTAGE LEVEL CLAIMS.— Section 403(r)(2) (21 U.S.C. 343(r)(2)) is amended by adding after clause (E) the following:

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