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Essentially, condoms are tested and FDA approved for vaginal use only. The FDA is typically provided with testing documentation from condom manufacturers based exclusively on vaginal use, and consequently there are no established guidance documents available from the FDA for condoms used for AI [anal intercourse]. For many years, in the US and elsewhere, it was considered taboo to discuss AI. In recent years, the subject was discussed at a special summit conference conducted by the FDA, specifically intended to encourage manufacturers to produce condoms for AI, however, none of the manufacturers who attended the meeting followed through. No existing condom manufacturer would risk producing such testing data as the failure rate for breakage, leakage and viral permeability would be significantly higher than testing results for vaginal use.
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Fascinating interview about the research and development work behind creating a condom specifically for anal intercourse and prepping it for clinical trials and eventual (like 2014) FDA review.
IRMA - Rectal Microbicide Advocacy: A condom specifically for anal intercourse?
