Controversial Issues
FDA seeking to label condoms less effective in protecting against STDs
May, 2008 - A recent GAO letter to Rep. Tom A. Coburn, M.D. and the House Homeland Security and Governmental Affairs Committee revealed ongoing Food and Drug Agency's (FDA) efforts to alter the language on condom labels to more accurately convey the risk of contracting a sexually transmitted disease while using a condom.
Currently, condom packaging carries the statement: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." The FDA suggested that condom makers label their products this way in 1998. But shortly thereafter, scientists raised concerns that condoms may not provide the same degree of protection against all STDs.
In 2000, a multi-agency panel comprised of FDA and other federal agencies, including the Center for Disease Control, reviewed medical literature related to the effectiveness of condoms in preventing HIV/AIDS and other STDs. The panel concluded that consistent condom use decreased the rate of HIV/AIDS transmission by approximately 85 percent and that there was insufficient information to determine the association between condom use and Human Papillomavirus (HPV) infection or disease.
For the next four years, the FDA and other federal health agencies continued to review the scientific evidence related the effectiveness of condoms in preventing various STDs. In a 2005 notice of proposed rulemaking concerning male latex condoms, FDA noted: "condoms, when used correctly and consistently, provide less protection against HPV than against certain other STDs."
The findings of the medical review have prompted the FDA to reconsider how condoms should be labeled. Specifically, they want to add language that identifies the risk of certain STD transmission, such as HPV and HIV, "that can be transmitted through contact with infected skin outside the area covered by the condom."
The FDA is now nearing the completion of its draft guidance on condom labeling, which offers language explaining that condoms can greatly reduce, but not eliminate, the risk of acquiring or transmitting HIV and other STDs like HPV. When the suggested packaging labels were opened to the public for comment, the FDA received over 400 comments, about half of which suggested that the recommended labeling language was confusing.
The influx of comments prompted the agency to conduct a study to evaluate public understanding of the proposed labeling recommendations and help shape the final language. FDA officials said that the agency was still analyzing the results of the study.
