Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -61

Accepted - Volume 14

Comment Record
Commentor Mr. Paul Gammrano Date/Time 2003-01-30 06:44:49
Organization Montclair State University (Adjunct Professor)
Category Health Professional

Comments for FDA General
1. General Comments Before labeling the Nonoxynol 9 products with any statements that the chemical substance does not kill STD/STI pathogens, one would hope that there is conclusive scientific (experimentative) evidence that it is not effective. If it is partially effective, the statement should reflect precisely which pathogens (i.e. causing syphilis, gonorrhea, chlamydia, etc.) this substance can kill on contact. Ongoing studies should be conducted if necessary, ith changes to lableing, as needed...

EC -61