New Condom Label Guidance from FDA Addresses Herpes, HPV


The federal Food and Drug Administration (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 genital herpes and HPV.

Spurred by lawmakers who advocated abstinence-based prevention messages and were skeptical of the value of condoms in preventing sexually transmitted infections (STIs), Congress passed a law in 2000 that mandated FDA to review and update condom labels as needed.

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 [STIs], 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 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 herpes simplex virus, the FDA pointed to research that demonstrated the protective value of condoms against infection with genital herpes (Wald et al). The agency also cited data that demonstrates the value of condom use in significantly reducing HPV acquisition among females (Winer et al.).

In response to the finding, Deborah Arrindell, ASHA vice-president of health policy, commented “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.”

The full text of the final rule is available online.

Winer, R.L., et al, Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women, NEJM, 2006 June 22;354(25):264554.
Wald, A., et al The Relationship Between Condom Use and Herpes Simplex Virus Acquisition, Annals of Internal Medicine, 2005 November 5;143(10):70713.