2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC5
Submitter : Mrs. Marni Bregman Reinhardt Date & Time: 11/17/2005 12:11:00
Organization : Mrs. Marni Bregman Reinhardt
Category : Individual Consumer
Issue Areas/Comments
Labeling condoms in this way could deter people from using them who need them the most! Condoms are the most effective way to prevent pregnancy and STDs, and changing the labeling may result in less use. Abstinence education is NOT effective in preventing pregnancy; condom use needs to be encouraged by any means possible.