2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC8
Submitter : Ms. Lauren Hill Date & Time: 11/18/2005 02:11:45
Organization : Ms. Lauren Hill
Category : Individual Consumer
Issue Areas/Comments
Highlighting condom limitations in prominent labeling, such as the outer package, will only dissuade users. Having worked in the HIV field for many years, we rely on condom use as the primary HIV/STD prevention strategy for those who are currently sexually active. It is important to ENCOURAGE people to protect themselves and their partners. While older adults may understand condom efficacy with or without the proposed labeling, sexually active or potentially sexually active teens may not. If the perceived risk of STD transmission is the same with or without a condom, what would be the point in using one (if using a condom would only dampen the sexual experience)? The outer package labeling should reflect that condoms are the most effective means of HIV/STD prevention outside of abstinence/monogamy, however are not 100% effective. Such labeling would provide accurate initial information, and those desiring more details of condom efficacy limitations should be directed to the package insert.
Nonoxyl-9 (N-9) should carry a warning label regardless of the partner's HIV status. If one-third of those infected with HIV in the United States do not know their status, condoms lubricated with N-9 should not be used at any sexual encounter.

If during every hour of every day two youth between the ages of 15-24 are infected with HIV, isn't it important to do everything possible to encourage prevention, including prominently highlighting the positives of condom efficacy?