Food and Drug Administration - December 18, 2007
Richard Klein & Kimberly Struble

The U.S. Food and Drug Administration (FDA) issued a final rule on December 18, 2007 requiring manufacturers of over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning stating that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs).

Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.

FDA is issuing the rule in an effort to correct misconceptions that N9 protects against sexually transmitted diseases, including HIV infection,

Nonoxynol 9 is approved as a vaginal contraceptive that works by damaging the cell membrane of sperm. It has been shown in laboratory studies to damage the cell walls of certain organisms that cause STDs and to be active against some STD-causing bacteria and viruses. Over the years, many consumers have come to believe that N-9 could reduce the potential for transmission of HIV and other STDs. FDA believes that the membrane-damaging effect can harm the cell lining of the vagina, cervix and rectum, thereby increasing the risk of HIV and STD transmission.

FDA is requiring that the labels warn consumers that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

In January, 2003 FDA proposed new warning statements and other labeling information for these products after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were, in fact, at higher risk for HIV infection than women using a placebo gel. Because these and other studies have shown that use of products containing N9 cause vaginal and rectal irritation that can heighten the chance of becoming infected with HIV from an infected partner, FDA believes the warning will empower consumers to make better informed decisions about the use of these products, and better protect the public health.

This rule is being finalized following a public comment period and a thorough analysis of information and views from consumers, health care providers, academicians and industry. FDA is requiring that labeling of OTC vaginal contraceptive/spermicidal products containing N9 bear the following warnings:

• For vaginal use only
• Not for rectal (anal) use
• Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
• Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control.
• When using this product you may get vaginal irritation (burning, itching, or a rash)
• Stop use and ask a doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis

Other information in the new labeling includes:

• Studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the risk of getting HIV/AIDS from an infected partner.
• You can use nonoxynol 9 for birth control with or without a diaphragm or condom if you have sex with only one partner who is not infected with HIV and who has no other sexual partners or HIV risk factors
• When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate the risk of catching or spreading HIV, the virus that causes AIDS.
• Use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors
• Ask a health professional if you have questions about your best birth control and STD prevention methods

FDA is issuing the final rule to provide a clear, consistent message that N9 is not effective in preventing HIV transmission, and that N9 may actually facilitate transmission of the disease for those who are at risk for HIV/AIDS. The final rule is consistent with FDA's draft guidance for N9 use with condoms.

The full text of the final rule is available at www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf (PDF also available on AEGiS here)

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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FD071204

SOURCE: Food and Drug Administration (FDA).

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