Warning Required for Nonoxynol 9 Over-the-Counter Contraceptives
Over-the-counter (OTC), stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) must now include a warning that the chemical N9 does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs).
Stand-alone spermicides include gels, foams, films, or inserts that are used by themselves for contraception.
FDA is also requiring that these products carry warnings that N9 can irritate the vagina and rectum, which may increase the risk of getting HIV/AIDS from an infected partner.
FDA issued these requirements in a final rule on Dec. 18, 2007. In January 2003, FDA proposed new warning statements and other labeling information for these products after results from a major study showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a gel with an inactive ingredient (placebo). The rule was finalized following a public comment period and a thorough analysis of information and views received during the comment period.
Consumers can protect themselves from getting HIV and other STDs by:
- practicing abstinence
- being in a monogamous relationship where neither partner is infected
- using condoms consistently and correctly. (When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV.)
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: December 19, 2007