Page:United States Statutes at Large Volume 108 Part 5.djvu/838

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108 STAT. 4328 PUBLIC LAW 103-417—OCT. 25, 1994 (2) by striking the period at the end of subparagraph (5) and inserting "; or"; an4 (3) by adding at th^ end the following new subparagraph: "(6) an ingredient described in paragraph (fiO in, or intended for use in, a dietary supplement.". (c) FORM OF INGESTION. — Section 411(c)(1)(B) (21 U.S.C. 350(c)(1)(B)) is amended— (1) in clause (i), by inserting "powder, softgel, gelcap," after "capsule,"; and (2) in clause (ii), by striking "does not simulate and". SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BUKDEN OF PROOF ON FDA. Section 402 (21 U.S.C. 342) is amended by adding at the end the following: "(f)(1) If it is a dietary supplement or contains a dietary ingredient that— "(A) presents a significant or unreasonable risk of illness or injury under— "(i) conditions of use recommended or suggested in labeling, or "(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use; "(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurguice that such ingredient does not present a significant or unreasonable risk of illness or injury; "(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to af&rm or withdraw the declaration; or "(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement. In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis. Notification. «(2) Before the Secretary may report to a United States attorney a violation of paragraph (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orjQly and in writing, at least 10 days before such notice, with regard to such proceeding.". SEC. 6. DIETARY SUPPLEMENT CLAIMS. Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the following new section: "DIETARY SUPPLEMENT LABELING EXEMPTIONS 21 USC 343-2. «SEC. 403B. (a) IN GENERAL. —A publication, including an article, a chapter in a book, or an ofl[icial abstract of a peer-reviewed scientific publication that appears in an article and was prepared