Condom expiration dating goes into effect March 25, 1998 -- FDA final rule.
This article was originally published in The Gray Sheet
Executive Summary
LATEX CONDOMS CURRENTLY MARKETED WITH EXPIRATION DATES WOULD NEED MORE TESTING if the original studies did not account for the maximum amount of time the condoms could remain unpackaged, FDA says in its final rule on expiration dating of condoms. Current condom expiration dates based on real-time testing are acceptable under the rule, the agency says. "If however, such real time expiration dates were based upon testing of products that were not first left unpackaged for the maximum amount of time" allowed by the manufacturers, the testing "must be confirmed" by real-time testing requirements outlined in the reg. The testing does not have to include the accelerated aging studies outlined in the reg.