The study measured and compared consumer understanding of the labeling recommended for latex condoms under FDA's 1998 guidance document, "Latex Condoms for Men, Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions," which is found on currently marketed latex condoms, and the latex condom labeling proposed in the 2005 draft guidance document, "Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex." The results of the study were used in FDA's final rulemaking process.
The study found that readers with lower reading levels and those with less education (two variables not highly correlated) had lower comprehension scores than those with higher reading levels. However, there were no differences based on age, race, ethnicity, income, or the type of neighborhoods where the respondents resided. The study found that most participants understood the basic message in the current and proposed labeling that latex condoms help protect against transmission of sexually transmitted infections (>80% correct responses). When comparing equivalent questions between the current and proposed latex condom labeling, for every comparison with a significant difference in rates of comprehension, the difference favored the current latex condom labeling over the proposed latex condom labeling. Most study participants did not understand the more complex messages about the relative degree of protection provided by condoms against different sexually transmitted infections (<30% correct responses). FDA's proposed labeling was lengthier, with considerably more information than current labeling. Shorter and simpler labeling will more likely result in better consumer comprehension.
Report Title: Food and Drug Administration (FDA) Condom Label Comprehension Study: Stage One Report of Findings; Report may be obtained from Federal Contact
Agency Sponsor: FDA, Food and Drug Administration
Federal Contact: Paula Silberberg, 240-276-3234
Performer: M. Davis and Company, Inc.
PIC ID: 8956