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This article was originally published in The Gray Sheet

Executive Summary

STD LABELING STATEMENT REQUIRED ON INDIVIDUAL CONDOM WRAPPERS within six months, FDA says in April 8 letters to manufacturers of latex and natural membrane condoms. The letters stipulate that statements on the efficacy of condoms in preventing the spread of sexually transmitted diseases be placed "in a prominent location on both sides of each individual condom wrapper and on the principle display panel of the outer package." Under the new policy, packaging for natural skin condoms must state that "this product is intended to prevent pregnancy and should not be used to 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." The statement should also be "added to current directions for use," FDA says. Latex condom packaging must carry the statement: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." An expanded version of the statement listing the applicable STDs must also be included in directions for use. FDA says that the list should include the STDs "chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis." If the labeling changes are not implemented within six months, FDA says it will consider the products misbranded and they will be subject to regulatory action. The new labeling can be implemented without a 510(k), according to the agency. The labeling requirement goes significantly beyond FDA's current policy for condom labeling, which requires that manufacturers clearly state whether their products are indicated for contraception, preventing the transmission of STDs, or both ("The Gray Sheet" Feb. 27, 1989, p. 11). The existing policy also does not specify where such statements are to be placed on the packaging of products. FDA explains in its letters to manufacturers that it is implementing the new requirements because it believes that "it is imperative to take additional steps to inform the sexually active population about which contraceptives have the potential to protect against STDs and which do not." The agency notes that consumer groups and health professionals have informed FDA that "in spite of education efforts on both a local and national level, high risk sexual behavior continues and leads to increased incidence of STDs, including human immunodeficiency virus. FDA believes that clear labeling will help to promote better use of contraceptive products with respect to STD protection." The new policy marks the second labeling initiative in a month that affects latex condoms. FDA recently announced that it will require manufacturers of latex-containing medical devices to add a statement to their principle display panels saying that the product contains latex ("The Gray Sheet" March 29, I&W-3). FDA's new policy also requires that efficacy statements on preventing the transmission of STDs be placed on labeling of oral contraceptives and three other non-barrier contraceptives: UpJohn's Depo Provera injectable contraceptive; Wyeth-Ayerst's Norplant implantable contraceptive; and intrauterine devices. The statements must say that these products are intended only to prevent pregnancy and do not prevent the spread of STDs. The agency currently is not requiring new labeling for other types of contraceptives such as spermicides, cervical caps, diaphragms and American Home Products' Today sponge.

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