The agency issued a final rule today requiring that manufacturers of OTC stand-alone vaginal contraceptive and spermicidal products containing nonxynol 9, or N9, include a warning that the doesn’t provide protection against infection from HIV or other sexually transmitted diseases. Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception.

“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,” says Janet Woodcock, the FDA’s deputy commish for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, in a statement. “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.”

The agency is requiring the labels warn consumers that 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 info for these products after results from a clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N9 weren’t protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel.

Here’s the rule.