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In Brief: Condom marketing

This article was originally published in The Tan Sheet

Executive Summary

Condom marketing: FDA is making a Feb. 23, 1994 policy statement available to manufacturers, distributors and importers on the marketing of "condom-like" products, including those labeled as novelty items, that cautions that such products are subject to the regulations for medical devices, the agency announced in an Aug. 3 Federal Register notice. FDA believes that some marketers have "misinterpreted" an earlier policy statement and are marketing functional condoms as novelty items without complying with leak-testing requirements, GMPs and other requirements...
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