Condoms May Get Warning Labels : FDA Reviews Safety of Lambskin Variety; Some Imports Rejected, Officials Say

The U.S. Food and Drug Administration is considering requiring the equivalent of a warning label on lambskin condoms--especially popular in some segments of the gay community--to underscore the possibility that they could permit the spread of the AIDS virus and other sexually transmitted diseases.

And the FDA, in new data released in response to inquiries by The Times, said an ongoing inspection program focusing on latex prophylactics has encountered isolated batches in which slightly more than one in 40 condoms had serious leakage problems.

High Failure Rates

Emphasizing that overall condom failure rates--both domestic and foreign-made--remain within voluntary guidelines adopted by medical device makers, top FDA officials also revealed that condoms from five foreign manufacturers have recorded failure rates high enough that their shipment within the United States has been forbidden.

The FDA declined to identify the foreign manufacturers involved, saying the information remains proprietary under existing federal law. But the agency said products of the affected firms were among 16 separate condom recalls ordered since early April. In one instance, the recall involved a batch of 26,200 condoms. The FDA said it believes all batches affected by the most serious failures were successfully intercepted.

FDA Deputy Commissioner John Norris said although the hastily organized inspection program has focused only on latex rubber condoms, the agency was concerned about safety questions raised about the so-called lambskin condoms and was considering the possibility of the warning label.

In a telephone interview from Washington, Norris said the FDA has attempted to follow the controversy closely. “The issue of the appropriate role of other than latex rubber condoms has been studied and the results of our early analysis are being reviewed,” Norris said. “It is certainly going to lead to consideration of what the labeling should be like on non-latex condoms.”

Norris said a requirement for a warning label was one of several possible FDA actions. Other FDA sources said the warning label requirement was in the early stages of active consideration. Formal promulgation of rules mandating such labeling would require an extensive notice, public comment and appeal process.

Scientists involved in various aspects of condom research applauded the possible warning label action. Ongoing research in both the United States and Canada has indicated that lambskin condoms--made from intestinal membranes--allow the leakage of the human immunodeficiency virus (HIV) as well as hepatitis B and herpes. While the researchers emphasized that suspicions about the condom are the result of only laboratory studies, they said the gravity of the AIDS epidemic justifies intervention.

“I think the evidence currently sort of suggests that” a warning label would be appropriate, said Dr. Gerald Bernstein, a USC expert who is helping to organize a large, Los Angeles-based study of condom effectiveness funded by the government’s National Institute of Child Health and Human Development. “I think if there is any doubt that it (the lambskin condom) is going to be effective, people should be discouraged from using them.”

The lambskin condom issue is of major importance in the gay community because, even though such prophylactics account for only about 5% over the overall condom market of about 325 million sold per year, lambskin varieties are popular among gays because they are thought to be resistant to breakage during anal intercourse and enhance sexual sensation.

Dr. Marcus Conant, of UC San Francisco--who first questioned but then said he agreed with conclusions by Canadian researchers that such condoms are possibly dangerous--also concurred. “My inclination is to say that, given the seriousness of the AIDS epidemic, people who are at risk should get (this) information as quickly as possible. Our data suggest that if an individual is infected with the AIDS virus or is having sex with someone they suspect is, they should use a latex condom”--not a lambskin one.

Two major brands of lambskin condoms are sold in the United States--Fourex, made by Schmid Laboratories of Little Falls, N.J., and Naturalamb, made by Carter-Wallace Inc., of New York City.

The actions by FDA were the latest developments in a dispute over the effectiveness of condoms as a weapon in the fight against AIDS. The controversy broadened last week with the report of the lambskin condom data and the release of the FDA results in its ongoing inspection program. A government research report also said there is no clinical proof in human tests that condoms are effective in preventing the spread of the AIDS virus.

Norris and other FDA officials also said the agency has increased by about 3,000--to a total of 54,000--the number of latex condoms it has inspected under the unusual product safety program begun in early April. The results represent 219 batches of condoms, 20% of which on average failed the inspections and were ordered withheld or withdrawn from the market.

Norris emphasized that the failure rate does not mean that 20% of all condoms in the tested batches had failed. He said the FDA utilizes a statistically complex system for the random selection of condoms, tested in groups of 80 also randomly selected from large shipments.

Ten percent of the batches of American-made condoms failed, as did 30% of the foreign batches.

Overall, Norris said condoms--especially those made in the United States--have adhered to an average failure rate of about 3.3 condoms over every 1,000 in distribution, a rate he termed within acceptable safety limits.

But Norris and other FDA officials said some isolated batches of condoms have recorded failure rates far in excess of those limits. Some of the worst batches of condoms, FDA officials said, have shown failure rates of between two and three out of 80 condoms.

Norris said it was not possible--because of the complex statistical model used for selection of condoms to be checked--to compute a precise failure rate that would indicate the percentage of all condoms that may be substandard. He said the agency was sufficiently concerned about safety questions that it established the testing program in which FDA inspectors conduct safety tests on tens of thousands of condoms.

The program is unique for the FDA, which generally does not test products under its jurisdiction directly--relying instead on manufacturing process audits, mandatory reporting of quality control problems by manufacturers and other techniques.