2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC3
Submitter : Ms. Susan Keller Date & Time: 11/17/2005 12:11:36
Organization : Ms. Susan Keller
Category : Individual Consumer
Issue Areas/Comments
I strongly recommend against a change in labeling that responds to political pressure rather than new scientific data. The effect of the proposed change may be to discourage rather than encourage condom use for those who are sexually active. Discouraging condom use for those who remain sexually active anyway will lead to more unwanted pregnancies and a rise in sexually transmitted disease. All that in order to appease a particular political constituency will serve to further reduce public confidence in the authority of the FDA.