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The Honolulu Advertiser
Posted on: Friday, July 11, 2008

FDA cracks down on condom imports

By Elizabeth Lopatto
Bloomberg News Service

Regulators urged steps to prevent a trickle of leaky condoms being shipped to the U.S. from becoming a flood.

One faulty sheath will cause a whole shipment to be detained, the Food and Drug Administration said in its final guidelines for the industry and agency employees. Measures were originally proposed in 2000.

The FDA today also posted guidelines for medical gloves, which like condoms are made of latex.

"Some foreign manufacturers and shippers repeatedly attempt" to ship leaky articles, the agency said.

Condoms, when they work, help prevent pregnancy and the spread of diseases such as AIDS, gonorrhea and syphilis.

Leaky condoms have been shipped from China, India, Korea and Thailand, as well as the UK, Greece, Japan, Italy and Germany.

Condoms and latex gloves, according to the FDA, undergo what is known as the "water leak test," set forth in a "Compliance Policy Guide." If just one style of condom fails in a shipment that contains a variety — "unlubricated, lubricated, spermicidally lubricated, ribbed, etc." — all must be detained and "a separate style should be taken for each style that the field office wishes to test."

Styles shouldn't be mixed in one sample.

The FDA has three levels of detention. First offenders have to show their products are safe — using an independent U.S. laboratory, for example — before the shipment is freed. A repeat offense will get a warning about manufacturing deficiencies. A bad shipment after that will lead to a full ban.

No repeat shippers were listed as of June 17.