21 U.S.C. § 343-2 — Dietary supplement labeling exemptions

(a) In general A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared 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 consumers when it— (1) is not false or misleading; (2) does not promote a particular manufacturer 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. (June 25, 1938, ch. 675, § 403B, as added Pub. L. 103–417, § 5 , Oct. 25, 1994 , 108 Stat. 4328 .) CFR Title Parts 21 5 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 20 , 25

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