FDA warns vs expired, unregistered condoms

June 6, 2017

The Food and Drug Administration (FDA) Tuesday warned the public against the use of condoms found to have either expired certificate of product registration or not registered. Based on FDA Advisory No. 2017-138, a total of six condom products, which are considered as medical devices, that do not have valid certificates. "Post-marketing surveillance activities conducted by the FDA have verified that PlaySafe Condom Easy Pack Long Love + Ribbed, PlaySafe Condom Extrasafe, and Feel Condom Vibra have not gone through the registration process of the agency and have not been issued with CPR," said the FDA. "Furthermore, it was found out that the CPRs of PlaySafe Condom Fix-Tex 002, PlaySafe Condom Fix-Tex Long Shock, and Feel Condom 4 in 1 are already expired," it added. The FDA said the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited under the Food and Drug Administration Act of 2009. "Since the mentioned products did not undergo the evaluation process of the FDA, the agency cannot guarantee their quality and safety," said the FDA. The public is advised not to buy any of these products. The FDA said all concerned establishments are warned not to advertise, sell, or distribute the said products until such have been issued with the corresponding certificate of product registration. DMS