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FDA sets guides for condom labels
The federal government wants condom labels to specify the kinds of sexually transmitted infections they can and cannot protect against.
An HIV/AIDS advocacy group reacted positively to the Food and Drug Administration’s proposal. However, Sen. Tom Coburn, who wrote the law asking for new condom labels, said the agency was still offering “inconclusive assurances” about the products.
Currently, condom labels say they are generally effective in reducing the risks for pregnancy or sexually transmitted diseases (STD), particularly HIV/AIDS. Their most urgent warning is that latex can cause allergic reactions.
Under the FDA’s proposed language, packaging would say that condoms provide “less protection” from herpes and human papillomavirus (HPV) because those STDs are spread via skin contact “outside the area covered by the condom.”
Still, “[u]sing latex condoms every time you have sex may still give you some benefits against these STDs,” the FDA language said, urging consumers to bring any questions to health care workers or public health agencies.
The FDA further wants condom labels to say that nonoxynol-9 (N-9), a spermicidal lubricant, should not be used by people at risk of catching HIV. Studies show that N-9 can irritate vaginal or rectal skin and increase the likelihood of HIV transmission.
Mr. Coburn, an Oklahoma Republican and a physician, applauded the FDA’s language on N-9 but said the agency “continues to promote inconclusive assurances” about condoms, especially their effectiveness against HPV, which causes cervical cancer.
The FDA language “claims condoms ‘may’ provide protection against cervical cancer,” said Mr. Coburn, author of the 2000 legislation requiring updated condom labels.
“This is speculation rather than scientific fact and is misleading,” he said, adding that with 20,000 cervical cancer deaths in the past five years, women deserve more accurate information.
Julie Davids, executive director of the Community HIV/AIDS Mobilization Project, commended the FDA “for sticking to 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,” she said.
The new guidance applies to latex condoms, which make up about 98 percent of the market; rules for other condoms are forthcoming.
Condom makers are not required to use exact FDA language, but they have to include the information in some form on their packages.
The FDA rules are scheduled to appear next week in the Federal Register. A 90-day public comment period follows.
This article is based in part on wire service reports.
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