Food and Drug Administration - November 17, 2008

The Food and Drug Administration (FDA) published a final rule on November 10, 2008 amending the classification regulation for male condoms made of natural rubber latex (latex condoms) and latex condoms with spermicidal lubricant containing nonoxynol-9 (N-9), designating a guidance document containing labeling recommendations as a special control for latex condoms.

The final rule will become effective January 9, 2009.

FDA is establishing the labeling guidance as a special control because it ensures that manufacturers will address the issues identified in the guidance. Regular guidance imposes no requirements. However, where a guidance document has been designated as a special control by a rule, manufacturers must address the issues identified in the guidance, either by following the recommendations in the guidance, or by some other means that provides equivalent assurances of safety and effectiveness.

Establishing a guidance document as a special control affords greater flexibility than a rule mandating specific labeling language, and can facilitate updating of the labeling as new scientific information becomes available because the special control permits manufacturers to use any labeling that affords equivalent assurances of safety and effectiveness for latex condoms.

In developing the rule and guidance, FDA evaluated a variety of scientific evidence and information about condoms and STIs. to assess the overall effectiveness of latex condoms in preventing transmission of STIs.

Based on review of scientific information and of existing latex condom labeling, FDA concluded that existing latex condom labeling was medically accurate in presenting the conclusion that, overall, condoms are effective in reducing the risk of sexually transmitted infections (STIs).

However, to help consumers make appropriate choices for their particular needs, and therefore to ensure the safe and effective use of condoms, FDA is establishing the labeling special control to address some additional, more nuanced information about condoms and STIs, as well as to provide information about contraception, and about appropriate directions and precautions for use of latex condoms.

The regulatory changes are intended to help ensure that latex condoms are used safely and effectively by providing labeling that conveys a concise, accurate message that neither exaggerates the degree of protection provided by latex condoms, nor undervalues overall STI-risk reduction provided by latex condom use.

The November 10, 2008 Federal Register Notice of Final Rulemaking, which contains detailed information about the rule, and FDA's findings regarding effectiveness of latex condoms for a variety of STIs, is available on the FDA web site at http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26825.htm

Background information is also available about the earlier Proposed Guidance for Condom Labeling.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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