The U.S. Food and Drug Administration requires the warning on OTC (over-the-counter) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9), utilized in several stand-alone spermicides.
"FDA is issuing this final rule to correct the misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases," Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said.
The FDA issued the warning statements and other labeling information for these products in 2003, after finding results from a study conducted in Thailand and Africa that women utilizing a contraceptive gel product with N9 were not protected against HIV and other STDs (sexually transmitted diseases) and were at a higher risk of HIV than those on a placebo.
