Food and Drug Administration: Agency Complied with Statutory Requirement to Reexamine Condom Labels

Sexually transmitted diseases (STDs) affect men and women of all backgrounds and economic levels and remain a major public health challenge in the United States. While substantial progress has been made in preventing, diagnosing, and treating certain STDs, an estimated 19 million new infections occur annually. According to the Centers for Disease Control and Prevention (CDC), correct and consistent use of a male latex condom can reduce, but not eliminate, the risk of STD transmission. Although male latex condoms have been proven to be highly effective in preventing HIV/AIDS, concerns have been raised over the past decade that condom labels do not include accurate information about condoms' effectiveness in preventing other STDs, including the human papillomavirus (HPV). A provision enacted as part of the Consolidated Appropriations Act, 2001, required the Secretary of Health and Human Services (HHS) to reexamine existing condom labels to determine whether they are medically accurate regarding the effectiveness of condoms in preventing STDs. Congress asked us to address issues related to condom labels. In this report, we discuss the scope of this statutory requirement and assess the extent to which the Food and Drug Administration (FDA)--the agency within HHS responsible for the regulation of medical devices, including condoms--complied with the requirement.