FDA orders new Nonoxynol-9 warning

December 18, 2007

The U.S. Food and Drug Administration issued a final rule Tuesday requiring manufacturers of nonoxynol-9, or N9, to add a warning to the product's label.

The FDA said the warning must state the over-the-counter vaginal contraceptive and spermicidal product does not protect against infection by the human immunodeficiency virus that causes AIDS, nor does it protect against other sexually transmitted diseases.

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

The federal agency said consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship with an uninfected partner and by using condoms consistently and correctly.

The FDA said it issued the rule to correct misconceptions that the chemical N9 protects against sexually transmitted diseases, including HIV infection.

In addition, the FDA 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.

Copyright 2007 by United Press International

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