Page:United States Statutes at Large Volume 108 Part 5.djvu/839

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PUBLIC LAW 103-417—OCT. 25, 1994 108 STAT. 4329 by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consiuners when it— "(1) is not false or misleading; "(2) does not promote a particular msinufacturer or brand of a dietary supplement; "(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement; "(4) if displayed in an establishment, is physically separate from the dietary supplements; and "(5) does not have appended to it any information by sticker or any other method. "(b) APPLICATION. —Subsection (a) shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications as a part of the business of such retailer or wholesaler. "(c) BURDEN OF PROOF. —In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.". SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT. Section 403(r) (21 U.S.C. 343(r)) is amended by adding at the end the following: "(6) For purposes of paragraph (r)(l)(B), a statement for a dietary supplement may be made if— "(A) the statement claims a benefit related to a classicgd nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient •. or dietary ingredient intended to affect the structure or function , in humans, characterizes the documented mechanism by which J a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient, "(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and "(C) the statement contains, prominently displayed and in boldface type, the following: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.'. A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.". SEC. 7. DIETARY SUPPLEMENT INGREDIENT LABELING AND NUTRI- TION INFORMATION LABELING. (a) MiSBRANDED SUPPLEMENTS. —Section 403 (21 U.S.C. 343) is amended by adding at the end the following: "(s)If—