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

submitted 88 years ago by Pub. L. 103-417 to r/title-21-FOOD-AND-DRUGS · 223 words · no verdicts yet

in plain englishAI-generated · not legal advice

A reprinted publication about a dietary supplement is not "labeling" if it meets five conditions. It must be truthful, unbranded, balanced, physically separate in stores, and free of added stickers. The government must prove the publication is false or misleading if this exemption is challenged.

(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.

facts

- Citation: 21 U.S.C. § 343–2, titled "Dietary supplement labeling exemptions" - Placement in Code: Codified as § 403B of the Federal Food, Drug, and Cosmetic Act (ch. 675) - Original Enactment: Act of June 25, 1938, ch. 675; § 403B added by Pub. L. 103–417, § 5, Oct. 25, 1994, 108 Stat. 4328 - Length: 223 words, comprising three subsections (a)-(c) - Amendment History: One amendment count noted in metadata (the 1994 addition itself)

the actual law source: uscode.house.gov ↗public domain

(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.

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.

Source credit: (June 25, 1938, ch. 675, § 403B, as added Pub. L. 103–417, § 5, Oct. 25, 1994, 108 Stat. 4328.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 103-417 · 108 Stat. 4328

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.

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