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Home HPV Research HPV Research Final Rules Issued for Condom Package Lables

Final Rules Issued for Condom Package Lables

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FDA pokes a hole in the notion that condoms don’t work

The FDA has issued final rules that govern how condom packages are labeled, and says current evidence supports earlier findings that male latex condoms are effective against common STIs, including HPV and herpes.

A federal law sponsored by then-U.S. Representative Tom Coburn (R-OK) and passed in 2000 mandated FDA to review and update condom labels as needed.  Coburn, a physician who currently serves in the U.S. Senate, and other advocates of abstinence-based prevention messages were skeptical of the value of condoms in preventing sexually transmitted infections (STI), often pointing to HPV as a prime problem area.  At the time, the effectiveness of condoms in protecting against HPV, which can be passed through contact with skin that condoms don’t cover, was unknown.
The draft of the updated condom-package language released by FDA in 2005 sought to address such concerns, saying an example of an acceptable label includes language such as “Condoms provide less protection for certain [STI], including [HPV] infection, that can…be spread by contact with skin outside the area covered by a condom.” This only partially pleased critics who claimed the agency was misleading the public on the dangers of HPV and safer sex.

A subsequent review by FDA of epidemiological research on condom effectiveness published between 2004 and 2008, however, led the agency to announce in November that “latex condoms provide effective protection against all STIs evaluated.”  Regarding HPV, the agency pointed to data from a 2006 study that found the risk of HPV infection was reduced by 70% among young women whose partners use condoms consistently (Winer et al.) The FDA also cited research that demonstrated the protective value of condoms against infection with genital herpes (Wald et al.).

In response to the finding, Deborah Arrindell, ASHA vice-president of health policy, said “After many battles and much waiting, we welcome these final rules governing labeling of male latex condoms. Overall, the FDA concludes that the science supports condom effectiveness. This science-based document from the FDA will be helpful as we move forward to create sexual health policy that is based on science rather than ideology.  Let’s hope the ‘condom wars’ will soon be behind us.”

For more information, read the full text of the final rule.

Department of Health and Human Services (HHS). 21 CFR Part 884 [Docket No. FDA2004N0511] Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex AGENCY: Food and Drug Administration, HHS.
Winer, R.L. et al. Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women. New England Journal of Medicine, 2006. 354(25): 2645-54.
A Wald et al. The Relationship Between Condom Use and Herpes Simplex Virus Acquisition. Annals of Internal Medicine, 2005. 143(10):707-13.