2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC20
Submitter : Mr. Jeff Spieler Date & Time: 12/14/2005 11:12:17
Organization : United States Agency for International Development
Category : Federal Government
Issue Areas/Comments
GENERAL
GENERAL
I would like to submit the following three comments in reference to Docket No. 2004N-0556 - Condom Labeling:

1) I do not believe that there is any data to support the recommendation 'to leave space at the end of the condom and to remove remaining air from the condom' to prevent breakage as is instructed in the fourth bullet under subsection C. 'General labeling requirements' (page 5) in Section III. 'Existing Labeling Requirements' of the Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex.

2) An interagency working group led by the Johns Hopkins University INFO Project has come up with the following 5 essential steps for condom use: 1. Use a new condom for each act of intercourse; 2. Before any genital contact, place the condom on the tip of the erect penis with the rolled side out; 3. Unroll the condom all the way to the base of the erect penis; 4. Immediately after ejaculation, hold the rim of the condom and withdraw the penis while it is still hard; 5. Throw away the used condom safely. I recommend including these five steps in subsection C. 'General labeling requirements' (page 4-5) in Section III. 'Existing Labeling Requirements' and under 'Incorrect or Inconsistent Use' (page 14) in subsection A. 'Labeling Recommendations for Latex Condoms' of Section VI. 'Labeling Recommendations' of the Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex.

3) In Section VIII. 'References' of the Draft Guidance on labeling of male condoms, why not include the new and complete references found on page 69117 of the Proposed Rules section of the Federal Register Volume 70, No. 218 published November 14, 2005?

4) I fully support the FDA's decision as described on page 69111 of the Proposed Rules section of the Federal Register Volume 70, No. 218 that it would not be useful to include in condom labeling additional educational information about social behaviors or public health programs that can reduce HIV or STI transmission risks and consequences. This additional information should not be added to condom labeling.