FDAnews Device Daily Bulletin

FDA PROPOSES LABELING CHANGES TO CONDOMS

Nov. 14, 2005
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The FDA has suggested labeling changes for natural rubber latex condoms that include information on the extent of protection condoms provide in preventing pregnancy and the spread of sexually transmitted diseases (STDs).

The labeling provides important decisionmaking information for condom users to assist them in determining whether latex condoms are appropriate for their needs, according to the agency's draft guidance published in the Federal Register.

Among the recommended changes, "labeling should indicate that condoms can reduce, but do not eliminate the risk of pregnancy," the guidance said. Labeling also should include a table comparing pregnancy rates resulting from condom use to those resulting from other barrier contraceptive methods, it adds.

Regarding the prevention of STDs, labeling should indicate that latex condoms can greatly reduce, but do not eliminate, the risk of HIV transmission. Labeling also should indicate that latex condoms provide less protection for those STDs that can also be transmitted by contact with skin outside the area covered by a condom, such as genital herpes, the guidance said.

The FDA also issued a proposed rule on the topic, which if finalized would require the labeling changes. The draft guidance on labeling for male condoms made of natural rubber latex is online at http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0555-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0555-gdl0001.pdf). The proposed rule is at http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0556-npr0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0556-npr0001.pdf).

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