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FDA Suggests Warnings for Condoms

Times Staff Writers

Against a background of pressure from social conservatives, the Food and Drug Administration is recommending a new series of labels for condoms, warning that they “greatly reduce, but do not eliminate” the risk of some sexually transmitted diseases.

Though little noticed by the general public, the issue of condom labeling has become another battleground in the nation’s culture wars.

Social conservatives have been working in Congress and elsewhere to press their contention that unwarranted reliance on condoms encourages promiscuous behavior and can contribute to the spread of disease; many in this camp advocate abstinence on both medical and moral grounds. Many public health groups, as well as birth-control advocacy groups such as Planned Parenthood, argue that adding caveats to condom labels could discourage their use and thus increase the likelihood of unprotected sex.

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The guidelines mandate that within 12 months of final approval, all labels contain several new warnings, including this one: “When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of pregnancy and the risk of catching or spreading HIV, the virus that causes AIDS.” Previously, the FDA warning labels on condoms warned only of allergic reactions to latex.

The FDA proposal, in the form of a guidance document for condom manufacturers, was posted on the FDA’s website Thursday and is to be published in the Federal Register on Monday. It will be subject to a 90-day public comment period. After that, the FDA is expected to adopt new guidelines on consumer information labels for condom boxes and foil packages.

Though the proposal appeared to represent an attempt at compromise, neither camp was entirely satisfied, in part because the condom issue involves social policy as well as science.

“It has taken the FDA five years to issue these simple guidance regulations for condom labels, despite the fact that the scientific consensus has long recognized that condoms do not provide effective protection” against certain sexually transmitted diseases, said Sen. Tom Coburn (R-Okla.), a physician and advocate of abstinence before marriage who first championed the review when he was in the House.

Criticizing the FDA’s pace of looking at the record, Coburn said, “The FDA should stop playing political games with the health and lives of Americans.”

FDA spokesman Yier Shi said: “We consulted with other agencies, we reviewed findings, we evaluated hundreds of scientific studies. A thorough review takes time.”

The FDA’s extensive review had been mandated by an amendment Coburn attached to an appropriations bill that President Clinton signed in 2000.

Shepherd Smith, president of the Institute for Youth Development, said condoms “have been hyped as offering protection. That isn’t the truth.”

Founder of an organization that seeks to help teenagers “avoid alcohol, drugs, sex, tobacco and violence,” Smith said the new labels would be a welcome step.

“When we see messaging to kids that says ‘Be safe, use a condom,’ we don’t think that’s an honest message,” he said.

And Dr. Tom Fitch, board chairman of the Medical Institute for Sexual Health, based in Austin, Texas, hailed the proposed regulations. Fitch said the FDA’s new language was important because condoms used consistently could prevent HIV in 90% of cases, but for other sexually transmitted diseases, condoms “may not help.”

If Coburn, Smith and Fitch represent the campaign for more labels, Dr. Vanessa Cullins, vice president for medical affairs of Planned Parenthood Federation of America, represents those who are concerned about the consequences of adding more warnings on a product that many young people say they are reluctant to use.

Cullins said her initial reading was that the FDA is “moving in the right direction” by proposing labels “based on science.” But she expressed concern that the labeling “underplays the importance of condoms in preventing sexually transmitted diseases. They’re still the best protection for sexually active individuals.”

Deborah Arrindell, vice president for health policy at the American Social Health Assn., said “at first glance, what the FDA produced was a science-based approach.” She lamented that the “politically charged issue” was centered around “a debate about abstinence rather than a debate on how to better protect people from disease and pregnancy.” She also said some of the FDA’s language would defy easy understanding by consumers.

In another part of the new labels, the FDA wants manufacturers to warn that the spermicide nonoxynol-9 could irritate the vagina, which “may increase the risk of getting HIV/AIDS from an infected partner.” Based on the same studies that prompted the FDA to warn away from the product, Cullins said, Planned Parenthood has already stopped distributing condoms containing nonoxynol-9.

Coburn said that the FDA had been delinquent in not acknowledging the studies earlier.

But at the Alan Guttmacher Institute in Washington, health policy analyst Heather Boonstra, criticized the FDA’s decision on the nonoxynol-9 spermicide, saying that the study showing an increased risk tested women who had used the spermicide three times a day, not the typical usage.

She also criticized the FDA language on another part of the warning label, on human papilloma virus or HPV, which says that “condoms provide less protection for certain sexually transmitted diseases, including genital herpes and HPV infection” but then adds that “using a condom also may lower your risk of developing HPV-related diseases, such as genital warts and cervical cancer.”

That mixed message, she said, is “actually confusing and burdensome and I’m afraid will make people more cautious about using condoms.” And, she added, HPV rarely leads to cervical cancer.

Likening the public health contribution of condoms to those of seat belts, Boonstra said too much information can send an unintended message. “We tell people to buckle up,” she said. “We don’t tell them they could get hurt in the gut.”

Coburn criticized the FDA for not going far enough on HPV. “In the five years it took the FDA to implement this law, over 27 million Americans have become infected with HPV and nearly 50,000 women have been diagnosed with invasive cervical cancer,” he said in a statement.

The FDA has been embroiled in another controversy this year over science and sexuality. The agency postponed a decision on whether to allow over-the-counter sales of the morning after contraceptive pill, despite evidence showing that the drug is safe. Regulators could not resolve the charged issue of whether teenage females should also have access to the contraceptive without a prescription. The FDA’s inaction prompted its women’s health chief to resign.


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