Page:United States Statutes at Large Volume 90 Part 1.djvu/460

 90 STAT. 410

PUBLIC LAW 94-278—APR. 22, 1976 "TITLE XI—GENETIC DISEASES, H E M O P H I L I A PROGRAMS, AND SUDDEN INFANT D E A T H SYNDROME."

Effective date.

42 USC 300b note.

(c) The amendments made by subsections (a) and (b) shall take effect July 1, 1976. TITLE V—FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS SEC. 501 (a) Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding after section 410 (21 U.S.C. 349) the following new section: "VITAMINS AND MINERALS

21 USC 350. 21 USC 321, 341, 343.

"Children."

Food labeling.

"Food to which this section applies."

"SEC. 411. (a)(1) Except as provided in paragraph (2) — "(A) the Secretary may not establish, under section 201(n), 401, or 403, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies; "(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful; "(C) the Secretary may not limit, under section 201(n), 401, or 403, the combination or number of any synthetic or natural— "(i) vitamin, "(ii) mineral, or " (iii) other ingredient of food, within a food to which this section applies. "(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph, the term 'children' means individuals who are under the age of twelve years. "(b)(1) A food to which this section applies shall not be deemed under section 403 to be misbranded solely because its label bears, in accordance with section 403(i)(2), all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals. "(2)(A) The labeling for any food to which this section applies may not list its ingredients which are not vitamins or minerals (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 403. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary. "(R) Notwithstanding the provisions of subparagraph (A), the labeling and advertising for any food to which this section applies may not give prominence to or emphasize ingredients which are not— "(i) vitamins, "(ii) minerals, or "(iii) represented as a source of vitamins or minerals. "(c)(1) For purposes of this section, the term 'food to which this section applies' means a food for humans which is a food for special dietary use— " (A) which is or contains any natural or synthetic vitamin or mineral, and

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