C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE › Subpart A—Definitions and Interpretations

21 C.F.R. § 369.10

Conspicuousness of warning statements

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Necessary warning statements should appear in the labeling prominently and conspicuously as compared to other words, statements, designs, and devices, and in bold type on clearly contrasting background, in order to comply with the provisions of section 502(c) and (f)(2) of the act. The warning statements should be placed in the labeling in juxtaposition with the directions for use and, in any case, should appear on the label when there is sufficient label space in addition to mandatory label information.

Notes of Decisions
Cited in 1 case, 2002–2002 · leading case: Calvit v. Procter & Gamble Mfg. Co., 207 F. Supp. 2d 527 (M.D. La. 2002).
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Calvit v. Procter & Gamble Mfg. Co., 207 F. Supp. 2d 527 (M.D. La. 2002). “Plaintiff quotes 21 C.F.R. 369.10, a regulation issued by the Federal Drug Administration, relating to labeling of products and cites the opinion of her (now excluded) expert that the label used by P & G in this case “violates” that regulation.”
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