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Condom label changes

This article was originally published in The Gray Sheet

Executive Summary

FDA will delay a final rule on new label requirements for latex condoms with spermicidal lubricant containing nonoxynol-9 in order to evaluate comments, the agency says in a final rule for those without N-9. The latter rule, slated for publication in the Nov. 10 Federal Register, simplifies previously proposed label changes and requires manufacturers to state whether the devices are latex or another material. It also requires them to update directions for use; explain latex condoms prevent pregnancy but do not completely eliminate the risk; and state that condoms reduce the risk of sexually transmitted infections such as HIV and gonorrhea but are less effective against HPV and herpes. The label changes are more direct than proposed changes, which industry had disparaged as "too complex." The final rule also gives firms an extra month to comply if their condoms are currently marketed - totaling 13 months after publication of the final rule

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