Sexual Health Buzz

After an extended review, the federal Food and Drug Administration (FDA) recently published final rules governing the labeling of male latex condoms. Following the evaluation of both clinical and epidemiological research as well as public comments on proposed changes to labeling, the FDA concluded that “scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common STIs.”

Changes to condom labeling were originally proposed in 2005. Among the proposed changes at that time included language specific to STDs: “Condoms provide less protection for certain STDs, including genital herpes and human papillomavirus (HPV) infection, that can also be How to Use A Condom spread by contact with infected skin outside the area covered by the condom. Condoms cannot protect against these STDs when they are spread in this way.”

When the FDA solicited public comment on the suggested changes in 2005, they received more than 100 responses from consumers, health professionals, industry, academia, state and Federal government agencies, as well as professional societies and organizations. After a review of public comment, as well as current research on condom effectiveness, the FDA concluded that recent studies confirmed that latex condoms can reduce transmission risk, and cited recent studies on HPV specifically that provided additional evidence to support this conclusion.

As stated in the federal register, “The benefit of this final rule is that establishing the labeling guidance as a special control ensures that manufacturers will provide consumers with the information they need to make an informed decision regarding the use of latex condoms and to use them safely and effectively. The labeling guidance helps ensure that information provided to consumers does not undervalue the overall STI-risk reduction provided by latex condom use, but does not exaggerate the effectiveness of latex condoms against certain types of STIs.”

This final rule will go into effect January 9, 2009. While latex condoms that were legally marketed prior to the effective date of this final rule will have 11 months from that date to comply with the new labeling requirements, new products will be required to comply immediately upon the rule taking effect.