New Labeling to Provide Information About Contraceptives and STDs

FDA has notified the manufacturers of certain contraceptives that labeling accompanying their products must state that they do not provide protection from sexually transmitted diseases (STDs), including AIDS. The labeling changes are expected by the fall [1993].

These products include oral contraceptives, intrauterine devices, implantable and injectable contraceptives, and natural membrane ("lambskin") condoms. FDA has instructed the manufacturers of these products to change the labeling so that information about the lack of protection against STDs is displayed prominently in clear language for the consumer.

FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other sexually transmitted diseases in sexually active individuals, particularly adolescents and young adults, who may not know that products intended to prevent pregnancy are not necessarily effective for other purposes.

Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Although the labeling for natural membrane condoms has stated that the products do not offer protection from STDs, such labeling has not been required for most other contraceptives. The labeling varies according to the type of contraceptive:

Oral contraceptives, Norplant, Depo Provera, and IUDs:
This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Natural membrane ("lambskin") condoms:
This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. In order to help reduce the risk of transmission of many STDs, including HIV infection (AIDS), use a latex condom.

Latex condoms:
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. [This message is to appear on individual condom wrappers, as well as on the outer package.]

FDA, in conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom, should be changed as well.

(FDA BULLETIN, Department of Health and Human Services, Food and Drug Administration, June 22, 1993.)


[email protected] (Sat Feb 11 02:12:09 1995)
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