Published February, 2006
Comments on FDA Condom Labeling Guidance, The Center for HIV Law and Policy (2006)
These comments were drafted by CHLP on behalf of several HIV legal and service organizations in response to a proposal by the FDA to revise condom package labeling guidelines to include misleading information on condom shortcomings as a disease prevention method. While agreeing in substantial part with the scientific accuracy of the revisions to the labeling guidelines, the commentators argue that the addition of complicated, incomplete language on the risk of STI transmission by skin-to-skin contact could confuse consumers and discourage condom use by suggesting that condoms do not provide sufficient protection to justify their use. The comments point out that “promoting condom use to prevent HIV, for example, has been quite effective in slowing disease transmission yet presents ongoing challenges, as most people would prefer not to use condoms at all . . . . The clear, accurate and simple message is that although condoms provide less protection against STDs such as genital herpes and human papillomavirus (HPV), they do provide a level of protection." The comments also urge inclusion of relevant consumer warnings and broader information on the effectiveness of contraceptive options.
In November 2008, after more than two years, the FDA issued guidelines and a statement reaffirming the effectiveness of condoms in preventing the spread of HIV and other STIs.
Copyright Information: CHLP encourages the broad use and sharing of resources. Please credit CHLP when using these materials or their content. and do not alter, adapt or present as your work without prior permission from CHLP.
Legal Disclaimer: CHLP makes an effort to ensure legal information is correct and current, but the law is regularly changing, and the accuracy of the information provided cannot be guaranteed. The legal information in a given resource may not be applicable to all situations and is not—and should not be relied upon—as a substitute for legal advice.