November 25, 2005

New FDA condom labels wont overstate failures

by Eric Resnick

Washington, D.C.--In what some call a surprising turn of events, the Food and Drug Administration is not requiring condom labels to understate their effectiveness.

Religious conservatives had pushed for a requirement that the labels exaggerate the failure rate of condoms, in keeping with an ?abstinence only? message.

The November 11 announcement resulted from a review process mandated by Congress in 2000.

Social conservatives, including Sen. Tom Coburn, R-Okla., say the new labeling ?falls short? and is based on ?inconclusive assurances.?

AIDS activists, however, are lauding the new regulations and the FDA?s decision to be guided by ?sound public health rather than scare tactics.?

?I would hope that the clarifying language marks the start of a real commitment to educating the American public about the importance of condom use, and public health programs to help people use them correctly and consistently,? said Julie Davids of the Community HIV/AIDS Mobilization Project.

The current regulations require manufactures to say that their products are effective in reducing the chance of pregnancy and getting sexually transmitted diseases, including HIV.

The new packages will state that the condoms are believed to be less effective against some sexually transmitted diseases, including herpes and the human papilloma virus. Both can be transmitted through contact with skin not covered by condoms, though condoms significantly reduce the risk of transmission.

HPV is widespread in the adult population. Some strains are known to cause genital warts and cervical cancer.

Religious conservatives had wanted the new rules to say that condoms were less effective against all diseases, an idea not supported by scientific research.

"We must not be lulled into a false sense of security. Abstinence ensures the best possible future for our children: a future not marred by disease and unplanned pregnancies,? said Linda Klepacki of Focus on the Family.

The new rules also call for packages to warn against use of condoms lubricated with the spermicide nonoxynol-9 because it can irritate the walls of the rectum and vagina, increasing the chance of HIV infection.

Once published in the Federal Register, the new rules will be open for public comment for 90 days before taking effect.

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