LATEX CONDOM STUDY FLAWED

[FDA has received] inquiries about a Mariposa Foundation study that ranks the quality of various brands of condoms. Media reports of the studies suggest that some brands leak and therefore may not provide protection against AIDS and other sexually transmitted diseases.

FDA believes that the study is flawed and therefore cannot be relied upon to judge the relative quality of various brands of condoms. The agency is concerned that some people may stop using condoms as a result of this study.

FDA's position continues to be that latex condoms, if used consistently and correctly, provide highly effective protection against sexually transmitted diseases, including AIDS.

In 1988, the Mariposa Foundation, a private research group in Topanga, Calif., conducted a laboratory study of 31 condom brands to select condoms to be used in a clinical trial that would have evaluated their protection against HIV, the virus that causes AIDS. The clinical trial was never conducted.

One part of Mariposa's laboratory study measured the ability of condoms to serve as a physical barrier to HIV. Test results indicated that at least eight brands offered excellent protection against the virus while at least five allowed some leakage.

FDA does not believe these test results should be relied on, however, because the study was flawed for several reasons:

1. Too few batches were sampled to generalize about any brand as a whole. Mariposa sampled three batches for most brands. A sample of a few hundred condoms from a batch of a million might provide adequate information about that particular batch if the sample is taken in a scientifically random fashion, but it cannot establish the performance of the entire brand. Environmental and manufacturing conditions vary too much from one batch to another to allow conclusions about the effiacy of a particular brand on the basis of a small study sample.

   FDA regularly inspects condom manufacturers and tests samples of their products. When a faulty batch is found, the agency prevents the sale of that batch. This applies both to domestic and imported condoms.

2. Some brands include condoms made by different manufacturers. Some batches from a single brand in the Mariposa study could have come from a different manufacturer than the majority of condoms sold under that brand name.

3. The Mariposa Foundation did not consider possible deterioration due to improper storage conditions or age. Condoms deteriorate rapidly when subjected to extremes of temperature, and latex also deteriorates as it ages.

FDA is establishing expiration dating for all latex condoms. Most domestic condoms already display an expiration date on the packaging. New regulations will require expiration dates for both domestic and imported latex condoms.

[Editor's Note: For information about this study, contact the Mariposa Education and Research Foundation, 3123 Schweitzer Drive, Topanga, CA 90290. Telephone: 818-704-4812. See also: Voeller B. Nelson J. Day C. Viral leakage risk differences in latex condoms. AIDS Research and Human Retroviruses. 1994;10(6):701-10.]

(FDA TALK PAPER. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, T93-45, October 12, 1993.)