Page:United States Statutes at Large Volume 108 Part 5.djvu/842

 108 STAT. 4332 PUBLIC LAW 103-417—OCT. 25, 1994 keted in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.". SEC. 9. GOOD MANUFACTURING PRACTICES. Section 402 (21 U.S.C. 342), as amended by section 4, is amended by adding at the end the following: "(g)(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). "(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available smalytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.". SEC. 10. CONFORMING AMENDMENTS. (a) SECTION 201. —The last sentence of section 201(g)(1) (21 U.S.C. 321(g)(1)) is amended to read as follows: "A food or dietary supplement for which a claim, subject to sections 403(r)(l)(B) and 403(r)(3) or sections 403(r)(l)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.". (b) SECTION 301. —Section 301 (21 U.S.C. 331) is amended by adding at the end the following: "(u) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413.". (c) SECTION 403.— Section 403 (21 U.S.C. 343), as amended by section 7, is amended by adding after paragraph (s) the following: "A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.". SEC. 11. WITHDRAWAL OF THE REGULATIONS AND NOTICE. The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void and of no force or effect Federal insofar as it applies to dietary supplements. The Secretary of Health wuWication ^^^ Human Services shall publish a notice in the Federal Register to revoke the item declared to be null and void and of no force or effect under subsection (a). 21 USC 343 SEC. 12. COMMISSION ON DIETARY SUPPLEMENT LABELS. "°*®' (a) ESTABLISHMENT.— T here shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the "Commission").

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