FDA’s Proposed Condom Label Comprehension Study Submitted To OMB
This article was originally published in The Tan Sheet
Executive Summary
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
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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. The agency is conducting the study to evaluate current and potential condom users' comprehension of the three versions of the labeling. FDA will use the results of the study for its "condom labeling recommendations to provide important risk/benefit and use information associated with condoms in an easily understood language," the agency notes. The proposed information collection has been submitted to the Office of Management and Budget, and comments on the study should be submitted to OMB by July 16, the notice says. The study will test the versions of the labeling with pre-screened participants contacted in shopping malls or other central locations, FDA says. The study will "follow a sequential design" to enable testing of both the current and proposed labels in the first stage before preparing a revised version to be tested in the second stage. Participants will receive approximately 20 questions related to the three versions of the label. Each label will be evaluated by 400 participants. FDA's proposed rule published in November 2005 identified issues related to condom use requiring "special controls to provide reasonable assurances of safety and effectiveness," FDA said (1 (Also see "Latex Condom Labels Would Bear N-9, STD Warnings Under FDA Proposal" - Pink Sheet, 21 Nov, 2005.), p. 13). The proposed condom labeling language reads: "When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS." Current labeling must state latex condoms help reduce risk of HIV transmission and other STDs if used properly. This statement must appear on individual condom wrappers, on product packages and in consumer information material. - Jessica Lake ([email protected]) |