WEDNESDAY DEC 19, 2007 (Foodconsumer.org) -- The Food and Drug Administration announced a final rule Dec. 18 that requires manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing nonoxynol 9 or N9 to put a warning in the new labeling to inform consumers that use products of this type do not prevent HIV and sexually transmitted diseases (STDs).

Stand-alone spermicides containing N9 include gels, foams, films, or inserts containing N9 that are used by themselves for contraception.

According to the FDA, use of a N9 based spermicide could actually increase the risk of HIV and other STDs infection.

Nonoxynol-9 or N-9 is a non-ionic nonoxynol surfactant. In addition to its use in contraceptives as a spermicide, it is also used as an ingredient in various cleaning and cosmetic products.

The chemical was at one time widely promoted as a protection against sexually transmitted infections including HIV, according to wikipedia.com.

But actually use of nonoxynol-9 can increase the risk of HIV infection by damaging the physical barriers of the rectum or vagina, studies showed, according to wikipedia.com.   Frequent use of nonoxynol-9 is linked to higher risk of urinary tract infections (UTIs).

“FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER).

“Clinical research has shown that N9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV.”

FDA wants a warning put in the labeling to indicate 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.

The rule resulted from a thorough analysis of information and views from consumers, health care providers, academicians and industry, FDA said in its announcement.

FDA is now 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 FDA wants put 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

The rule as FDA said is 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.