FDA To Conduct Surveys About Pregnancy Prevention Language On Condom Packaging
FDA plans to survey 1,200 people in shopping malls nationwide on their understanding of a condom's efficacy in preventing sexually transmitted infections, including HIV, and unplanned pregnancies based on current labeling, the agency said on Thursday in a notice on its Web site, Bloomberg/Arizona Republic reports. According to the notice, survey responses will be "considered in FDA's condom labeling recommendations to provide important risk/benefit and use information associated with condoms in easily understood language."
Congress in 2000 directed FDA to "determine whether [condom] labels are medically accurate regarding the overall effectiveness or lack of effectiveness," Bloomberg/Republic reports. The agency in a 2005 review found that many people who use condoms are unsure how often the contraceptive fails to prevent pregnancy with typical use or that they provide less protection from certain STIs, such as genital herpes, Bloomberg/Republic reports. FDA in 2005 also proposed that labels on condom boxes and wrappers show data on unplanned pregnancies and varying levels of protection against STIs (Bloomberg/Arizona Republic, 6/14).
In addition, the agency in November 2005 published a draft guidance document for latex condom manufacturers. The document included a proposal that labels be required to state that condoms "greatly reduce but do not eliminate" the risk of pregnancy and HIV infection when used correctly during sexual intercourse but provide "less protection" from other STIs, including human papillomavirus and herpes, because those STIs can be spread through skin-to-skin contact. However, the guidance also says that "using latex condoms every time you have sex may still give you some benefits against these" STIs (Kaiser Daily HIV/AIDS Report, 6/22/06). FDA also recommended that condoms with spermicidal lubricant nonoxynol-9 include a warning that the lubricant can cause irritation that raises the risk of HIV transmission.
Any label changes would apply only to male condoms made with natural rubber latex, which account for almost 98% of sales in the U.S., FDA said. Guidelines for products made with lambskin or synthetic materials will be issued at a later date, the agency said (Bloomberg/Arizona Republic, 6/14).
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