21 CFR 1143.7 – Language requirements for required warning statements
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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.