FDA's final rule requires warning for nonoxynol 9 OTC contraceptives

December 19, 2007

FDA's final rule mandates warning for nonoxynol 9 OTC contraceptives

The FDA has issued a final rule that requires manufacturers of OTC stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) to include a warning that the chemical N9 does not provide protection against infection from HIV or other sexually transmitted diseases (STDs). Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. 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. The full text of the final rule is posted atwww.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf.

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