---
kind: "section"
citation: "21 U.S.C. § 353c"
title: "21"
title_heading: "Food and Drugs"
number: "353c"
heading: "Prereview of television advertisements"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/353c"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §353c. Prereview of television advertisements

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) may require the submission of any television advertisement for a [drug](/usc/21/321.md?p=g-1) (including any script, story board, rough, or a completed video production of the television advertisement) to the [Secretary](/usc/21/321.md?p=d) for review under this section not later than 45 days before dissemination of the television advertisement.
- (b) **Review—** In conducting a review of a television advertisement under this section, the [Secretary](/usc/21/321.md?p=d) may make recommendations with respect to information included in the [label](/usc/21/321.md?p=k) of the [drug](/usc/21/321.md?p=g-1)—
  - (1) on changes that are—
    - (A) necessary to protect the consumer good and well-being; or
    - (B) consistent with prescribing information for the [product](/usc/21/360eee.md?p=13) under review; and
  - (2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the [drug](/usc/21/321.md?p=g-1) as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.
- (c) **No authority to require changes—** Except as provided by [subsection (e)](#e), this section does not authorize the [Secretary](/usc/21/321.md?p=d) to make or direct changes in any material submitted pursuant to [subsection (a)](#a).
- (d) **Elderly populations, children, racially and ethnically diverse communities—** In formulating recommendations under [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) shall take into consideration the impact of the advertised [drug](/usc/21/321.md?p=g-1) on elderly populations, children, and racially and ethnically diverse communities.
- (e) **Specific disclosures—**
  - (1) **Serious risk; safety protocol—** In conducting a review of a television advertisement under this section, if the [Secretary](/usc/21/321.md?p=d) determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the [labeling](/usc/21/321.md?p=m) of the [drug](/usc/21/321.md?p=g-1) involved, the [Secretary](/usc/21/321.md?p=d) may require inclusion of such disclosure in the advertisement.
  - (2) **Date of approval—** In conducting a review of a television advertisement under this section, the [Secretary](/usc/21/321.md?p=d) may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the [drug](/usc/21/321.md?p=g-1) under [section 355 of this title](/usc/21/355.md) or [section 262 of title 42](/usc/42/262.md), a specific disclosure of such date of approval if the [Secretary](/usc/21/321.md?p=d) determines that the advertisement would otherwise be false or misleading.
- (f) **Rule of construction—** Nothing in this section may be construed as having any effect on requirements under [section 352(n) of this title](/usc/21/352.md?p=n) or on the authority of the [Secretary](/usc/21/321.md?p=d) under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).

## Source credit

(June 25, 1938, ch. 675, § 503C, formerly § 503B, as added Pub. L. 110–85, title IX, § 901(d)(2), Sept. 27, 2007, 121 Stat. 939, renumbered § 503C, Pub. L. 113–54, title I, § 102(a)(1), Nov. 27, 2013, 127 Stat. 587.)

## Notes

### Editorial Notes

### Codification

Section was formerly classified to section 353b of this title prior to renumbering by Pub. L. 113–54.

### Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 331 of this title.