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Condom Distributors Given Go-Ahead on AIDS-Related Advertising

April 10, 1987

WASHINGTON (AP) _ Condom distributors have been given a government green light to advertise that latex condoms can help prevent the spread of AIDS.

They had been barred from making that assertion on their own until this week, even though Surgeon General C. Everett Koop and other government officials have been saying it for them for months.

The permission to include anti-AIDS benefits in advertising and labeling comes with Food and Drug Administration guidelines dated Tuesday and made public Friday.

Although condom labeling typically has said condoms are intended to prevent the spread of disease, manufacturers had not been allowed to make specific claims about their effectiveness in preventing AIDS or other diseases.

FDA spokesman David Duarte said the guidelines were in response to applications from several manufacturers seeking permission to mention AIDS in their labeling and advertising.

In a letter to all U.S. condom manufacturers, importers and repackagers, the FDA said:

″If you are currently marketing a latex condom and wish to claim that your product provides protection against STDs (sexually transmitted diseases), you should include appropriate labeling that reflects accurately the realistic expectations a consumer should have about the condom’s effectiveness.″

It goes on: ″With the spread of STDs, it has become very important that users be fully aware that latex condoms provide protection, but do not guarantee it, and that protection is lost of condoms are not used properly.″

The letter is accompanied by an example of what the FDA would find acceptable labeling and gives blanket permission for claims that do not depart ″significantly″ from this suggested wording:

″When used properly, the latex condom may prevent the transmission of many sexually transmitted diseases (STDs) such as syphilis, gonorrhea, chlamydial infections, genital herpes and AIDS. It cannot eliminate the risk. For maximum protection, it is important to follow the accompanying instructions. Failure to do so may result in loss of protection. During intimate contact, lesions and various body fluids can transmit STDs. Therefore, the condom should be applied before any such contact.″

In its letter, the FDA said condoms made with natural membranes may have a different permeability than latex and not lend themselves to the same degree of quality control.

″In the interest or prudence, therefore, FDA is requesting that you not label natural membrane condoms for protection against STDs,″ the letter said.

The letter said the ″FDA is also requesting that all condoms (all is underlined), whether they are labeled for protection against STDs or not, and whether made from latex, natural membrane, or any other material, include adequate instructions for use to maximize the degree of protection they afford.″

It includes an attachment with an explicit 10-step example that ″constitute(s) an acceptable set of instructions.″

While the FDA typically uses words like ″requesting″ and ″urging″ in its communications with the companies whose products it regulates, the companies recognize that to do otherwise invites legal action.

The letter from John C. Villforth, director of the Center for Devices and Radiological Health, concluded that the FDA ″intends to strengthen its inspection of domestic and foreign manufacturers for compliance with good manufacturing practices″ and also ″intends to monitor carefully the labeling, instructions for use, and other information provided to consumers ... to ensure that such information is accurate, balanced and useful.″

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