FDA cracks down on condom labels

February 2006

In response to a 2000 congressional mandate, the FDA published a draft guidance document for latex condom manufacturers to propose more specific condom packaging labels and to provide more accurate information about the product’s effectiveness.

The mandate required the FDA to review the medical accuracy of claims that condoms can prevent sexually transmitted diseases (STDs). After a five-year review, the agency concluded that condoms do not provide effective protection against certain STDs that spread through contact with infected skin outside the area covered by a condom. The proposed revised product packaging would read, “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.”

U.S. Sen. Tom Coburn, MD, (R-Okla.), who sponsored the FDA report, applauded the FDA’s recognition of the label information and, at the same time, criticized the guidance, saying it still makes inconclusive, exaggerated claims about condoms’ effectiveness.

“While I am encouraged that the FDA finally has recognized the inaccurate claims about contraceptives containing nonoxynol-9 (N-9) and the exaggerated claims of condom protection against STDs, the agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse,” Coburn said in a statement. Coburn claimed that condoms have never undergone FDA-approved clinical trials to evaluate the product’s safety and effectiveness in protecting against STDs, specifically human papillomavirus (HPV).

Label revisions suggested

The FDA, in consultation with the CDC and NIH, extensively reviewed available medical literature on the safety and effectiveness of condoms. The agency also reviewed available literature on N-9.

Findings indicated that condoms greatly reduce the risk of pregnancy and are highly effective in preventing HIV and STDs, such as gonorrhea, chlamydia, hepatitis B and trichomoniasis. Although condoms provide some protection against STDs, such as genital herpes, syphilis, HPV and chancroid, they are less effective for those that can be transmitted through contact with uncovered condom areas, according to the report.

The proposed language of the package inserts also states that condoms provide “less protection” from other STDs, including HPV and herpes, but “using latex condoms every time you have sex may still give you some benefits.”

The document addresses the risks and benefits of condoms containing N-9 and recommends including a warning label that reads:

• “The lubricant on this condom contains the spermicide nonoxynol-9 (N-9), which kills sperm; however, the amount of additional pregnancy protection provided by the N-9 has not been measured.”
• “The N-9 lubricant on this condom does not protect against HIV/AIDS or other sexually transmitted diseases.”

Studies suggest that this spermicide may increase the risks of STDs because it irritates vaginal and anal skin.

Additionally, the FDA proposed increasing regulatory control over latex condoms by moving them from class II (performance standards) to class II (special controls) guidance, therefore, indicating that condoms require additional measures beyond basic marketing and manufacturing oversight to ensure their safety and effectiveness.

Current guidance recommends that condom packaging indicate that latex condoms “will help to reduce the risk of transmission of HIV and many other STDs” without explicitly stating that they do not fully eliminate risk, according to the IDSA.

The changes and new warnings are slated to be included on all latex condom labels within one year of their final approval.

Reviewing evidence

Coburn had several qualms with the condom labeling suggestions. “The FDA guidance, for example, claims condoms may provide protection against cervical cancer,” which he said “is speculation rather than scientific fact and is misleading.”

He highlighted a meta-analysis published in November 2002 in Sexually Transmitted Diseases, which found that “available data are too inconsistent to provide precise estimates,” of a protective effect of condom use against HPV infection. The study also concluded that the data were insufficient to draw conclusions about condoms’ effectiveness to reduce the risk of transmission of genital ulcer diseases

FDA officials cite the conclusion of that meta-analysis in the Federal Register Notice: “while condoms may not prevent HPV infection, they can reduce the risk of genital warts, cervical intraepithelial neoplasia II or III, and invasive cervical cancer.”

In August 2003, Coburn and U.S. Rep. Mark E. Souder, (R-Ind.), chairman of the subcommittee on criminal justice, drug policy and human resources, wrote letters to Dara Corrigan, acting principal deputy inspector general of Health and Human Services, questioning whether the CDC was in compliance with the 2000 mandate, which regulates HPV education.

“Inasmuch as the new label recommendations finally acknowledge that condoms will not provide effective protection against some STDs, this is a step in the right direction,” Souder said in the statement.

For more information:

• Manhart LE, Koutsky LA. Do condoms prevent genital HPV infection, external genital warts, or cervical neoplasia: a meta-analysis. Sex Trans Dis. 2002;29:725-735.
• To read the FDA’s draft guidance “Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,” visit http://www.fda.gov/cdrh/comp/guidance/1548.html.
• Additional copies of the FDA’s draft guidance are available by calling the Center for Devices and Radiological Health’s Facts-On-Demand system at 800-899-0381 or 301-827-0111. Enter document number 1548.
• To view the hearing before the subcommittee of the Committee on Government Reform, U.S. House of Representatives, visit http://reform.house.gov/UploadedFiles/96225[1].pdf.