Contains Nonbinding Recommendations
Draft — Not for Implementation
588 other factors used to achieve emphasis (e.g., bolded lettering, bullets). However, FDA may object to
589 substantial differences in font size or the presentation of risk information in a difficult to read font size,
590 irrespective of the font size of benefit information, because this may seriously reduce the ability to see or
591 comprehend the risk information.
592
593 Even with identical risk and benefit font sizes, differences in type styles can render some information
594 easier to read than other information.
44
To be comparably prominent
and readable,
FDA recommends that
595 risk and benefit information be presented in type styles that are similar in the use of capitalization, serifs,
596 the weight of the type-face, the angle of the letters, the degree of flourishes and scripting, and other
597
typographical factors such as spacing (e.g., leading and kerning).
45
598
599 • Contrast
600
601 Contrast between text and background should not highlight the benefit information more than the risk
602 information.
603
604 Example 18: If benefit information in a piece is presented in white letters on a black background,
605 risk information should be presented with similar contrast. If the piece presents risk information
606 in a way that would make it difficult to discern (e.g., using white letters on a light gray
607 background or gray letters on a black background), the presentation may be considered false or
608 misleading.
609
610 Even if the background is a color designed to attract attention, the contrast influences the prominence of
611 the words once attention has been gained. In fact, printing words in some attention-grabbing colors (e.g.,
612 red) may make the words difficult to read.
46
Similarly, the placement o
f
risk information over pictures or
(2006). Provision of effective information. British Dental Journal, 201, 100; Sheedy, J.E., Subbaram, M.V.,
Zimmerman, A.B., & Hayes, J.R. (2005) Text legibility and the letter superiority effect. Human Factors, 47, 797-
815; Tantillo, J., Di Lorenzo-Aiss, J., & Mathisen, R.E. (1995) Quantifying perceived differences in type styles: An
exploratory study. Psychology and Marketing, 12, 447-457; Wogalter, M.S., & Vigilante, W.J. (2003) Effects of
label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics, 46, 327-
344.
44
English, E. (1944) A study of the readability of four newspaper headline types. Journalism Quarterly, 21, 217-
229; Mansfield, J.S., Legge, G.E., & Bane, M.C. (1996) Psychophysics of reading. XV: Font effects in normal and
low vision. Investigative Opthamology and Visual Science, 37, 1492-1501; Sheedy, J.E., Subbaram, M.V.,
Zimmerman, A.B., & Hayes, J.R. (2005) Text legibility and the letter superiority effect. Human Factors, 47, 797-
815; Tantillo, J., Di Lorenzo-Aiss, J., & Mathisen, R.E. (1995) Quantifying perceived differences in type styles: An
exploratory study. Psychology and Marketing, 12, 447-457.
45
See Arditi, A., & Cho, J. (2005) Serifs and font legibility. Vision Research, 45, 2926-2933; Baker, S. (2006)
Provision of effective information. British Dental Journal, 201, 100; Moriarty, S.E., & Scheiner, E.C. (1984) A
study of close-set text type. Journal of Applied Psychology, 69, 700-702; Paterson, D.G., & Tinker, M.A. (1947)
Influence of leading upon readability of newspaper type. Journal of Applied Psychology, 31, 160-163; Smither,
J.A., & Braun, C.C. (1994) Readability of prescription drug labels by older and younger adults. Journal of Clinical
Psychology in Medical Settings, 1, 149-159; Tinker, M.A., & Paterson, D.G. (1946) Effect of line width and leading
on readability of newspaper type. Journalism Quarterly, 23, 307-309.
46
See Pearson, R., & van Schaik, P. (2003) The effect of spatial layout and link colour in web pages on performance
in a visual search task and an interactive search task. International Journal of Human-Computer Studies, 59, 327-
353; but see Adams, A.S., & Edworthy, J. (1995) Quantifying and predicting the effects of basic text display
variables on the perceived urgency of warning labels: Tradeoffs involving font size, border weight, and color.
Ergonomics, 38, 2221-2237.
17