WASHINGTON, DC - The Food and Drug Administration, pressured by social conservatives in Congress to evaluate recent scientific evidence, is recommending a new label on condoms saying that they "greatly reduce, but do not eliminate" the risk of sexually transmitted diseases.
The FDA proposal, in the form of a 28-page document for condom manufacturers, was posted on the FDA's website today and is to be published in the Federal Register on Friday. After a 90-day public comment period, the FDA is expected to adopt new guidelines on consumer information labels for condom boxes and foil packages.
The issue has roiled both sides of the "safe sex" debate, with social conservatives arguing that informed consent for consumers could reduce promiscuous behavior and liberal activists arguing that too many label caveats could encourage people to have unprotected sex.
Neither side was entirely happy with the series of new labels recommended by the FDA.
"It has taken the FDA five years to issue these simple guidance regulations for condom labels, despite the fact that the scientific consensus has long recognized that condoms do not provide effective protection" against certain sexually transmitted diseases, said Sen. Tom Coburn (R-Okla.), who championed the cause when he was in the House and now in the Senate.
Coburn, a medical doctor, criticized the FDA for not going far enough to warn women that human papillomavirus (HPV) can lead to cervical cancer and that condoms do not provide effective protection against it.
"In the five years it took the FDA to implement this law, over 27 million Americans have become infected with HPV and nearly 50,000 women have been diagnosed with invasive cervical cancer," he said.
At the Alan Guttmacher Institute in Washington, health policy analyst Heather Boonstra said the FDA proposal "on the whole appears to be fairly balanced." But she criticized the FDA's language on HPV infection.
The proposed warning states that "condoms provide less protection for certain sexually transmitted diseases, including genital herpes and HPV infection." However, it adds that "using a condom also may lower your risk of developing HPV-related diseases, such as genital warts and cervical cancer."
That mixed message, Guttmacher said, is "actually confusing and burdensome and I'm afraid will make people more cautious about using condoms."
The new guidelines mandate that within 12 months of final approval, all labels include the following language: "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."
Dr. Tom Fitch, a pediatrician who is chairman of the board of the Texas-based Medical Institute for Sexual Health, said that the FDA's new language is important because condoms used consistently can prevent herpes and HIV in 90% of cases, but for other sexually transmitted diseases, condoms "may not help."
from The Los Angeles Times
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