Title 21 — Food and DrugsRelease 119-73

§343–2 Dietary supplement labeling exemptions

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IV— - FOOD › § 343–2

Last updated Apr 6, 2026|Official source

Summary

Allows exact, full reprints of articles, book chapters, or official scientific summaries written by the authors or editors to be shown with dietary supplements without being treated as product labeling, if they are accurate, do not promote a particular maker or brand, give a balanced view of the science (including when shown with similar items), are kept physically separate from the supplements in a store, and have nothing added to them. This rule does not stop a retailer or wholesaler from selling books or publications. If the government challenges a reprint as misleading, the government must prove it is misleading.

Full Legal Text

Title 21, §343–2

Food and Drugs — Source: USLM XML via OLRC

(a)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)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)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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 343–2

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73