FDA: Condoms Not Approved for Anal Sex

It hasn’t been kept a secret, but nobody ever really asked.  Here’s what else you may not know.

By David Heitz – Like this journalist on Facebook.

Will a condom prevent you from getting HIV? Here are some things to consider:

• The FDA never has never “cleared or approved any condoms specifically for anal sex,” the organization confirmed in a statement to Imstilljosh.
• When it comes to posterior intercourse, recent research shows condoms prevent seven out of 10 transmissions.

Meanwhile, the FDA has approved one form of HIV prevention, a once daily pill called Truvada used as PrEP, or pre-exposure prophylaxis. You can read all about PrEP in this special report published by Imstilljosh earlier this year.

Most people do not currently have access to PrEP, and many have indicated no interest in it, according to doctors. It can cost $1,200 per month for those without insurance.

So where does that leave us?

As HIV stakeholders across America debate the merits of PrEP and/or condom use, little attention has been given to the fact that standard penile condoms are not approved, nor likely tested, for anal sex.

 

“The FDA has not cleared or approved any condoms specifically for anal sex,” the U.S. Food and Drug Administration said in a statement to Imstillljosh.

 

The FDA provided Imstilljosh a statement made by former U.S. Surgeon General C. Everett Koop in 1987 about condoms before a congressional committee on energy and commerce. This link is to a PDF of a typewritten document, complete with scribbles and notes in the margins. In it, he says the use of a condom is the best method of reducing infection “known at this time for those who for one reason or another will not practice abstinence or monogamy.”

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Koop warned, however, that condoms “may have a failure rate of 10 percent when used as contraceptives.” The sentence originally ended with “but most studies show a better rate” but that was crossed out.

Later in the statement, in which he refers to condoms as “rubbers,” he writes: “Under conditions simulating the mechanical friction of vaginal intercourse, latex and natural membrane (skin) condoms have been shown to be effective barriers to HIV and other infectious agents, but caution should be used in extrapolating these limited studies to actual use.”

The statement originally referred to “sexual” intercourse, but it was crossed out and replaced with “vaginal” written over the top.

No stamp of approval

Indeed, when asked if the FDA requires condom companies to test their products for effectiveness in use during anal sex, the FDA told Imstilljosh the agency reviews submissions as they come in. “If a sponsor were to submit a marketing submission for condoms indicated for anal sex, the FDA would review that submission and make a determination based on the merits of that submission.”

The FDA would not confirm whether any such submissions were under consideration.

“The FDA does not share information about submissions unless or until they reach a public decision.”

 

But one inventor says he will have an FDA-approved anal condom on the market next year. Danny Resnic, chief executive officer of Origami Condoms, said his company has an anal condom in development. “We are working diligently towards a regulatory approval and subsequent launch date by 2015,” he told Imstilljosh. The condom has been investigated in clinical search among men who have sex with men at the Fenway Institute in Boston.

The National Institute of Health funded the trials, Resnic said. “These are feasibility studies and each involves a User Preference study and a Couples Acceptability and Performance Study. Typically the studies included 20-30 couples.”

Imstilljosh reached out to the makers of Trojan and LifeStyles condoms, two of the most popular brands of standard condoms in the U.S. We asked them:

1. Has your company ever marketed a condom to gay men? Why or why not? Is this difficult to do given the fact the FDA has on its Web site that condoms may be unreliable for anal intercourse?
2. Given the HIV epidemic, particularly in years past, why do you suppose nobody ever has come out with a condom proven safe for anal sex? Has your company explored the development of such a condom?
3. Does your company do its own safety testing as it pertains to condoms holding up for anal sex?
4. Does your company offer a product specifically recommended for anal sex?
5. Has your company any plans to develop a condom specific for anal sex?

Neither company answered any of the questions.

Tom Paolella, associate director for global corporate communications for Ansell, maker of Lifestyles, responded with, “Regrettably, we are unable to participate in your article.”

Bruce Weiss, vice president of marketing for Trojan Brand Condoms, provided this statement: “It’s important to use a condom for every sex act including anal sex. Condoms are the best form of protection when having sex. As the most trusted brand for more than 90 years, we continue to make sex as safe and pleasurable for all those who are sexually active.”

As old as the tire

Are condoms really approaching the century mark? In fact, they are almost 160 years old, according to Case Western Reserve University.

Standard penile condoms are effective, even during anal sex. The question is just how effective.

In an article published last year by AIDSMAP, a United Kingdom-based Web site which does not accept paid advertising, U.S. Centers for Disease Control official Dawn Smith reported that condom use stops seven out of 10 anal transmissions of HIV. She made the statement during a report at the Conference on Retroviruses and Opportunistic Infections.

But only one in six men used condoms consistently over the course of three years, Smith reported. The findings were made based on an analysis of data of HIV-negative men enrolled in the AIDSVAX and EXPLORE studies.

To Michael Weinstein, leader of AIDS Healthcare Foundation, condoms have proven effective for decades. He is a staunch condom proponent, sometimes attracting criticism from those who advocate for more modern HIV prevention methods such as PrEP.

[themify_quote]“We take the positions that we believe to be right and wait for the results,” he said in a statement to Imstilljosh. “Whether or not FDA approves condoms for anal sex there is incontrovertible evidence that they do work and that condom breakage is not a substantial issue. HIV infection rates fell drastically in the 1980s when condom use became a cultural norm for gay men in the United States.”[/themify_quote]

Last July, AHF partnered with LifeStyles on a “Know Your Status” social media campaign. It resulted in the donation of more than 20,000 condoms to AHF.

Meanwhile, a blog published last month by Dr. Judith Reisman, a conservative pundit, calls for a “class action lawsuit by AIDS victims and their loved ones” against groups such as “AIDS Healthcare Foundation, Planned Parenthood and a myriad of teachers and school systems, too many to count.”

Her blog, laden with derogatory descriptors for gay sex, makes the argument that condoms should not be recommended for use during anal sex since they are not FDA approved.

Resnic said condom manufacturers are not required to provide the FDA with safety data because they sell the condoms as a contraception medical device that is limited to penile/vaginal use. “In a common sense perfect world it would seem logical the FDA would require manufacturers to test condoms for anal use, however, it is unnecessary to the P&L business model of the condom manufacturers.”