Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -146

Accepted - Volume 14

Comment Record
Commentor Ms. Deborah Arrindell Date/Time 2003-04-16 18:42:31
Organization American Social Health Association
Category Association

Comments for FDA General
1. General Comments Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir/Madam, The American Social Health Association (ASHA) and the National Coalition of STD Directors (NCSD) appreciate the opportunity to comment on proposed label warning statements for Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol-9 [21 CFR Part 201]. The American Social Health Association has sought to eliminate sexually transmitted diseases (STDs) and their harmful effects on individuals, communities, and families since 1914. The National Coalition of STD Directors is a coalition of our nation’s directors of public health STD prevention programs in states, cities, counties and territories—the frontline of STD prevention efforts. We appreciate FDA’s commitment to providing accurate information regarding the limitations and potential risks posed by N-9. We are deeply concerned that many consumers incorrectly believe that N-9 provides protection against STDs and HIV. Consumers who rely on N-9 products for protection against STDs are putting themselves at great health risk. At the same time, we recognize the importance of N-9 as the only vaginal non-hormonal form of contraception within the control of women. Therefore, we fully support FDA’s plan to improve and increase the information available to consumers through labeling. We support the language proposed: “This product does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs). However, we believe this important STD warning should appear on the outer carton in addition to inclusion in package inserts. Consumers shopping for N-9 products should know before they open the package that the product does not protect against STDs. We fully commend FDA for the decision to encourage condom use, and support the statement as worded in the proposed rule. We would recommend that the STD warning be included on the outer carton, followed by “Correct use of a latex condom with every sexual act will help reduce the risk of getting the AIDS virus and other STDs.” This will ensure that sexually active consumers are immediately advised of the availability of over-the counter STD/HIV protection. Finally, we strongly urge the FDA to address rectal use of vaginal contraceptives containing N-9. These products are used both for lubrication and for protection against STDs. Many consumers are not aware that o-t-c contraceptives containing N-9 do not protect against STDs and facilitate transmission of HIV. N-9 is very dangerous when used rectally. Therefore, we urge the inclusion of an explicit warning about the danger of rectal use, advising consumers that rectal use could increase the risk of contracting HIV from an infected partner. This warning should be included on the carton and in the package inserts. We appreciate the opportunity to comment. For more information please contact, Deborah Arrindell, Senior Director of Health Policy, American Social Health Association, 202 789-5950,, 1275 K Street, NW, Suite 1000, Washington, DC 20005.

EC -146