Page:United States Statutes at Large Volume 108 Part 5.djvu/837

 PUBLIC LAW 103-417—OCT. 25, 1994 108 STAT. 4327 SEC. 3. DEFINITIONS. (a) DEFINITION OF CERTAIN FOODS AS DIETARY SUPPLEMENTS.— Section 201 (21 U.S.C. 321) is amended by adding at the end the following: "(f^ The term 'dietary supplement'— "(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: "(A) a vitamin; "(B) a mineral; "(C) an herb or other botanical; "(D) an amino acid; "(E) a dietary substance for use by man to supplement the diet by increasing the total dietsiry intake; or "(F) a concentrate, metaboHte, constituent, extract, or combination of any ingredient described in clause (A), (B), (C),(D),or(E); "(2) means a product that— "(A)(i) is intended for ingestion in a form described in section 411(c)(l)(B)(i); or " (ii) complies with section 411(c)(l)(B)(u); "(B) is not represented for use as a conventional food or asa soleitem ofameal orthediet;and "(C) is labeled as a dietary supplement; and " (3) does— "(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section ^ '•• 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is imlawfiil under section 402(f); and "(B) not include— "(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or "(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.". (b) EXCLUSION FROM DEFINITION OF FOOD ADDITIVE.—Section 201(s) (21 U.S.C. 321(s)) is amended— (1) by striking "or" at the end of subparagraph (4);

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