Not all condoms are safe, FDA warns
The Food and Drug Administration (FDA) said unregistered condoms and those with expired certificates of product registration (CPRs) might not work as intended.
“Since these products did not undergo the evaluation process of the FDA, the agency cannot guarantee their quality and safety,” the FDA said in an advisory posted on its website on Monday.
The World Health Organization says condoms may be used as contraceptives or serve as a barrier to the spread of HIV (human immunodeficiency virus) and other sexually transmitted infections.
The FDA said its postmarketing surveillance had verified that PlaySafe Condom Easy Pack Long Love + Ribbed, PlaySafe Condom Extrasafe, and Feel Condom Vibra did not go through the registration process and did not have a CPR.
It also found expired CPRs for PlaySafe Condom Fix-Tex 002, PlaySafe Condom Fix-Tex Long Shock and Feel Condom 4.
The FDA advised the public not to buy these condoms, whose manufacture, sale and distribution violated provisions of Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009.”
It warned establishments not to advertise, sell or distribute these condoms until CPRs had been issued for these products.
Regulatory actions and sanctions will be imposed on violators.
The FDA urged all local governments and law enforcement agencies to ensure these condoms are not sold or made available in their jurisdictions.
