Can the layout or the way information is presented affect whether an advertisement or labeling piece is in compliance with the regulations?
Yes, 21 CFR 202.1(e)(7)(viii) states that an advertisement may be false, lacking in fair balance, or otherwise misleading if it: “Fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.” For example, the presentation below of the word benefits and the word disadvantages would not be considered comparable. Although the words are the same point size, the color and contrast with the background make the word benefits much more noticeable than the word disadvantages.
