FDA issues rule for products containing nonoxynol 9

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

“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,” stated Janet Woodcock, FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director of the Center for Drug Evaluation and Research. “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.”

In addition, 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.

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