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

(a) A publication about a dietary supplement can be an article, a book chapter, or a peer-reviewed scientific abstract. Such a publication does not count as "labeling" when it is reprinted in full and sold alongside the supplement. This exemption applies only if five conditions are met. The publication must not be false or misleading. It must not promote one particular manufacturer or brand. It must present a balanced view of the science, alone or alongside other materials on the same topic. If displayed in a store, it must be kept physically separate from the supplements themselves. Finally, nothing — no sticker or other addition — may be attached to it. (b) This rule does not limit a retailer or wholesaler from selling books or other publications as a normal part of its business. (c) In any case brought under subsection (a), the United States government has the burden of proving that the publication is false or misleading.

The record. The source credit indicates that this section was not part of the original Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), but was added later as § 403B by § 5 of the Dietary Supplement Health and Education Act of 1994, Public Law 103-417, enacted October 25, 1994, and published at 108 Stat. 4328. The credit shows no subsequent amendments to this section since its addition in 1994. Historical context. Public Law 103-417, commonly known as DSHEA, is generally understood to have been enacted in response to a broader debate in the early 1990s over how the Food and Drug Administration should regulate dietary supplements — vitamins, minerals, herbs, and similar products — as distinct from conventional foods and drugs. The Act as a whole is commonly described as reflecting congressional intent to preserve consumer access to supplements and related information while establishing a distinct regulatory framework for them. The provision exempting certain publications from the statutory definition of "labeling" is consistent with that broader aim, as it appears to address concerns that FDA labeling rules might otherwise restrict the sale or display of books, articles, and abstracts alongside supplements. However, the record supplied here does not include committee reports or other legislative history establishing the specific reasoning behind this provision's particular conditions, and none should be presumed beyond this general understanding.