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Condom Labeling Guidance Simplifies “Intended Use” Statements

This article was originally published in The Tan Sheet

Executive Summary

FDA's special control guidance for labeling natural rubber latex condoms simplifies recommended statements in response to comments submitted to the agency and results of a label comprehension study

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Condom label changes

FDA delays a final rule on new label requirements for latex condoms with spermicidal lubricant containing noxoxynol-9 in order to evaluate comments, the agency says in a final rule that simplifies previously proposed label changes for natural rubber latex condoms without N-9. The rule, slated for publication in the Federal Register Nov. 10, requires manufacturers to label whether condoms 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 explain condoms reduce the risk of sexually transmitted infections such as HIV and gonorrhea but are less effective against HPV and herpes. The STI label changes are more direct than proposed changes, which industry complained were "too complex" (1"The Tan Sheet" Feb. 27, 2006, p. 12). The final rule gives manufacturers an extra month to comply if their condoms are currently marketed. They have 13 months after publication of the final rule to comply

FDA’s Proposed Condom Label Comprehension Study Submitted To OMB

FDA requests comment on a label comprehension study of current and proposed condom labeling as well as a future revised version, the agency states in a June 15 Federal Register notice

FDA-Proposed Label Changes For Condoms “Potentially Confusing” – C&D

FDA's proposed labeling changes for latex condoms should be modified to make wording more straightforward and consumer-friendly, according to Trojan condom marketer Church & Dwight

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