NON-LATEX CONDOM LABELING MUST DETAIL EFFICACY RISKS, LIMIT USE
This article was originally published in The Tan Sheet
Executive Summary
NON-LATEX CONDOM LABELING MUST DETAIL EFFICACY RISKS, LIMIT USE to latex-sensitive individuals in order to be marketed. FDA recently sent a letter to several firms developing non-latex, or "plastic," condoms informing them that labeling must indicate that although laboratory tests appear to demonstrate the devices' effectiveness against sexually transmitted diseases and pregnancy, efficacy has not been proven yet through clinical tests. Labeling also must state that the condoms are recommended only for individuals with latex sensitivities, according to industry officials.
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