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Title 21 — Food and DrugsRelease 119-73

§378 Advertising of foods

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VII— - GENERAL AUTHORITY › Part Part A— - General Administrative Provisions › § 378

Last updated Apr 6, 2026|Official source

Summary

Before starting an enforcement action under subchapter III about a food that is misbranded because of its advertising, the Secretary must notify the Federal Trade Commission. The notice must say what action the Secretary plans, describe the advertising that makes the food misbranded, explain why the Secretary reached that conclusion, and include the records and documents that support it. If the FTC tells the Secretary within 30 days that it is investigating, plans to sue, plans to issue a complaint, or is referring the matter to the Attorney General, the Secretary must wait. If, within 60 days after the FTC’s reply, the FTC or the Attorney General does not take the promised steps, the Secretary may go ahead. The notice and waiting rules do not apply when the Secretary finds an imminent health hazard. The Secretary must coordinate with the FTC to avoid duplicate actions.

Full Legal Text

Title 21, §378

Food and Drugs — Source: USLM XML via OLRC

(a)(1)Except as provided in subsection (c), before the Secretary may initiate any action under subchapter III—
(A)with respect to any food which the Secretary determines is misbranded under section 343(a)(2) of this title because of its advertising, or
(B)with respect to a food’s advertising which the Secretary determines causes the food to be so misbranded,
(2)The notice required by paragraph (1) shall—
(A)contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary’s determination that such advertising has caused such food to be misbranded, and
(B)be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.
(b)(1)If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under subchapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that—
(A)it has initiated under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act,
(B)it has commenced (or intends to commence) a civil action under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has commenced (or intends to commence) a civil action under section 5 [15 U.S.C. 45] with respect to such advertising,
(C)it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or
(D)pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to the Attorney General respecting such advertising,
(2)If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—
(A)the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary’s notice,
(B)the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or
(C)the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,
(c)The requirements of subsections (a) and (b) do not apply with respect to action under subchapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health.
(d)For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under subchapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect to such advertising.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is classified generally to subchapter I (§ 41 et seq.) of chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see section 58 of Title 15 and Tables.

Reference

Citations & Metadata

Citation

21 U.S.C. § 378

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73