Is the FDA putting gay men at risk?

The Food and Drug Administration (FDA) announced in December that it is adopting a new rule that would require warning labels on contraceptive products that contain the spermicide nonoxynol-9 (N-9) but the federal agency is delaying the establishment of a similar rule on condoms containing N-9.

The Deputy Director for the Global Campaign for Microbicides, Anna Forbes, said it appeared to her that the FDA was "stalling" on the implementation of the N-9 rules.

Microbicides refer to a wide range of topically applied products including gels, creams and suppositories that prevent the transmission of AIDS and other STDs. The Global Campaign is a nonprofit organization that works with a network of over 285 non-governmental organizations to help accelerate the development of microbicides. It has called for the removal of N-9 from all condoms.

The FDA is considering labeling requirements for N-9 condoms separately from other N-9 contraceptive products because it classifies condoms as "medical devices." The two major manufacturers of N-9 condoms, Church and Dwight, the makers of the Trojan brand, and Ansell, the maker of the LifeStyles brand, wrote to the FDA suggesting that warning consumers about N-9 condoms could be confusing and could stop some consumers from using condoms at all. That objection was the major factor in causing the FDA to delay N-9 labeling rules.

Citing that reason, the FDA opted to study the issue further. The first phase of the planned N-9 condom study will be completed by February 2008 and the second phase, which will take about 17 weeks, will begin after the FDA analyzes the first study, according to FDA spokeswoman Peper Long.

A number of AIDS organizations have joined with the Global Campaign in calling for the removal of N-9 from condoms.

In an advisory letter to the FDA last year, Fred Dillon, who was then the San Francisco AIDS Foundation's Public Policy and Communications Director, wrote: "[T]he San Francisco AIDS Foundation has joined with a broad coalition of women's health groups, HIV/AIDS organizations, state and local public health officials, and research scientists calling on manufacturers to remove N-9 from condoms and lubricants, because the small amount of N-9 they contain is dangerous if used rectally and offers no documented contraceptive benefit. While there has been progress on this front, we are disappointed that some companies continue to produce N-9 condoms. The San Francisco AIDS Foundation strongly encourages the FDA to take immediate steps to end the manufacturing or sale."

N-9 was once promoted as a way to reduce the risk of HIV transmission after it was shown to kill the AIDS virus in laboratory studies. But subsequent studies on humans showed it had just the opposite effect because it stripped the protective cells lining the rectum and vagina, leaving the user at a greater risk of HIV transmission.

The FDA says that the rule governing contraceptive products other than condoms is being finalized following a public comment period. The agency expects the rule will take effect on June 19, 2008.

Although condoms containing N-9 will not be affected by the new rule, the N-9 contraceptive products will include the following warning: "Use a latex condom without nonoxynol-9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors."

It its exhaustive 2001 report on N-9, the World Health Organization found that N-9 condoms do not provide users with any additional contraceptive benefit and "should not be promoted."

N-9 was once included in lubricants that were marketed to gay men. After a series of articles by this writer in 2002 about the health risks of N-9, all three major manufacturers who were producing N-9 lube agreed to stop. Most manufacturers of N-9 condoms including Mayer Laboratories, which produces Kimono Condoms, as well as the corporate giants, Durex and Johnson and Johnson, have voluntarily stopped producing N-9 condoms.

Contrary to the WHO report, the manufacturers who still make N-9 condoms, Church and Dwight and Ansell, have maintained that N-9 condoms provide an additional contraceptive benefit. The corporations reiterated that claim in 2006 in advisory letters to the FDA on N-9 condom labeling.

Forbes said that those corporations are making an "intuitive leap." Forbes said there is no evidence that the small amount of N-9 in condoms provides any benefit to the consumer.