21 CFR 1143.7 - Language requirements for required warning statements.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 1143 [§ 1143.1 - § 1143.13]

§ 1143.7 - Language requirements for required warning statements.

The text in each warning statement required in § 1143.3 or § 1143.5 must be in the English language, except as follows:

(a) In the case of an advertisement that appears in a non-English medium, the text in the required warning statement must appear in the predominant language of the medium whether or not the advertisement is in English, and;

(b) In the case of an advertisement that appears in an English language medium but that is not in English, the text in the required warning statement must appear in the same language as that principally used in the advertisement.

authority: 21 U.S.C. 387a(b), 387f(d), Pub. L. 117-103, 136 Stat. 49

source: 81 FR 29103, May 10, 2016, unless otherwise noted.

cite as: 21 CFR 1143.7