New condom labels urged

WASHINGTON — The Food and Drug Administration is recommending new labels for condoms that warn that they "greatly reduce, but do not eliminate" the risk of some sexually transmitted diseases.

Social conservatives have been working in Congress and elsewhere to press their contention that unwarranted reliance on condoms encourages promiscuous behavior and can contribute to the spread of disease; many in this camp advocate abstinence. Many public-health groups and birth-control advocacy groups such as Planned Parenthood argue that adding caveats to condom labels could discourage their use and thus increase the likelihood of unprotected sex.

The guidelines mandate that all labels contain several new warnings, including this one: "When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS." Previously, the FDA labels on condoms warned only of allergic reactions to latex.

The FDA proposal was posted on its Web site Thursday and is to be published in the Federal Register on Monday. It will be subject to a 90-day public comment period. After that, the FDA is expected to adopt new guidelines.

"It has taken the FDA five years to issue these simple guidance regulations for condom labels," said Sen. Tom Coburn, R-Okla., a physician and advocate of abstinence before marriage who first championed the review when he was in the House.

FDA spokesman Yier Shi responded: "We consulted with other agencies, we reviewed findings, we evaluated hundreds of scientific studies. A thorough review takes time." Indeed, the FDA's extensive review had been mandated by an amendment Coburn attached to an appropriations bill that President Clinton signed in 2000.

Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, fears the consequences of adding more warnings to a product that many young people say they are already reluctant to use. She also expressed concern that the new labeling "underplays the importance of condoms in preventing sexually transmitted diseases. They're still the best protection for sexually active individuals."