Title 21, Food and DrugsRelease 119-110

§343–2 Dietary Supplement Labeling Exemptions

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

Last updated Sep 22, 2026|Official source

Summary

Allows a full scientific article or official abstract, written by the author or the publication’s editors and reprinted exactly as published, to be used when selling dietary supplements without being treated as product labeling if it is truthful, does not promote a specific maker or brand, is shown with other balanced information on the topic, is kept separate from supplements in a store, and has nothing attached to it. This rule does not limit a retailer or wholesaler from selling books or publications as part of their business. If challenged in court, the United States must prove the article is false or misleading.

Full Legal Text

Title 21, §343–2

Food and Drugs, Source: USLM XML via OLRC

(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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 343–2

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110