2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC14
Submitter : Mr. Christopher Edwards Date & Time: 12/09/2005 04:12:09
Organization : UIC College of Pharmacy
Category : Academia
Issue Areas/Comments
As a student of the health sciences, I would like to add my two cents on this issue. I have reviewed the proposed changes and I feel that most of the changes would over complicate the matter. Most people do not take the time to read the all of the information on the box anyway. Beside that, the current packaging does an excellent job of explaining that while not foolproof, condoms do provide an excellent means to help prevent pregnancy and the transmission of HIV and other STDs. Although abstinence will prevent pregnancy and STD's, no one who using condoms is practicing this method.

It is a good idea to mandate an advisory about N-9 as possible being an irritant, but I think most of the manufacturers have voluntarily placed this warning on the package of all condoms with spermicidal lubricant. I would not include the part about N-9 not preventing HIV, because most people do not even know that there may be a connection between the two. Again, the simpler the labeling is, the more effective it will be.

Please, do not let politics get in the way of science. Thank you for listening.

Chris Edwards
Doctor of Pharmacy candidate 2008