FDA Issued Final Labeling Rules of Male Latex Condoms: Condoms Reduce Risk of HPV

On December 2, the Food and Drug Administration (FDA) published final rules governing the labeling of male latex condoms set to go into effect January 9, 2009. The biggest change to come out of the new labeling is the FDA’s conclusion that correct and consistent condom use reduces both the risk of infection with HPV (the Human Papillomavirus) as well as rates of HPV-related disease including cervical cancer and genital warts.
 
The new label change is the product of a three-year clinical and epidemiological review by the FDA. The FDA began this review of condoms at the behest of members of Congress and their supporters who are active proponents of an abstinence-only-until-marriage approach to prevention and were attempting to undermine the public’s confidence in the effectiveness of condoms as a method of preventing sexually transmitted diseases (STDs). They argued that because HPV can be transmitted through contact with skin that is outside of the area covered by a condom, the public should be told that condoms are ineffective against HPV.    
 
In truth, the evidence available today suggests that male latex condoms can reduce the risk of transmission of HPV as well as the rate of HPV-related health issues such as cervical cancer. One study found that women who correctly and consistently use male latex condoms reduced their risk of HPV infection by 70%.[1]
 
Public health professionals are optimistic about this new decision from the FDA hoping that it means a move away from ideological policies and toward prevention efforts lead by scientific evidence.    
 
“Many proponents of abstinence-only-until-marriage programs have attacked condoms as ineffective at protecting against STDs like HPV in order to justify the value of their own programs,” said William Smith, SIECUS’ vice president for public policy. “Thankfully we are seeing a return to evidence-based prevention and young people will hopefully once again learn about the importance of latex condoms for both pregnancy and disease prevention.”


[1] Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 884; Docket No. FDA-2004-N-0551, Deborah Arrindell/ASHA on HPV and FDA condom labels, accessed 10 December 2008, http://www.stdpreventiononline.org/index.php/resources/download/684 ; Winer, Rachel L et al, “Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women” Obstetrical & Gynecological Survey. 61(10):639-640, October 2006.

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