Caveat Rectum!

Repeat after me:

“No proven microbicides exist yet.”
“No microbicides have yet been proven to be safe and effective.”

Obviously, this is what we are all trying to change as advocates and researchers in this field. In the meantime, let’s remember this when faced on an alarmingly regular basis with unproven claims.

The Global Campaign for Microbicides maintains an Unproven Product Claims Watch, and for good reason! IRMA recently worked with GCM and the Terrence Higgins Trust in the UK to address one case of these cases (check the News section for the February 6 on the IRMA website). Sadly, it is far from the only one.

The situation would be funny – except that these products, which allegedly reduce the risk of transmitting HIV and other sexually transmitted infections, may in fact do the opposite. There is usually no proof that these products are even safe, let alone effective!

Bogus claims have appeared in all sorts of ways, as the following true examples demonstrate. So “Caveat Rectum!” For that matter, a warning to all orifices with delicate mucosal tissue: keep away from the following:

• Makers of industrial-strength detergents that claim that their product not only kills all pathogens in hospital settings at 50 paces, but can also be applied as a personal lubricant and protect you from infection. DANGER, DANGER!


• Seemingly friendly microbiologists who collect seaweed during the week, stew them on their stovetop at home in the evenings, and sell the resulting gel as a microbicide at your local farmer’s market on the weekend. DANGER, DANGER!


• Non-profit organizations claiming to address AIDS in Africa by providing sprays containing known irritants to mucosal lining to African women, and who manage to convince at least one African government to promote the spray for HIV prevention. DANGER, DANGER!


• Researchers who promote products easily found in the produce section of your local market, or any other product that is “natural”, “organic”, “already widely available and used” – yet not tested for safety or efficacy. DANGER, DANGER!

Believe me, once there are safe and effective microbicides available, you’ll hear all of us squealing with delight like a gaggle of gays at a Celine Dion concert. In the meantime, repeat after me:

“No proven microbicides exist yet.”
“No microbicides have yet been proven to be safe and effective.”

If you see any claims to the contrary, please notify IRMA and GCM. We’ll work with you to keep the world safe!

Fraudulent Claims Get an FDA Smackdown

News Alert
11 March 2008

FDA Warns Companies Importing and
Marketing Drugs Over the Internet
that Fraudulently Claim to Prevent and Treat STDs

The U.S. Food and Drug Administration issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).

Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

"The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs."

The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.

Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).

The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.

Issuing these Warning Letters is part of the FDA’s ongoing campaign against fraudulent products marketed on the Internet for serious and life-threatening diseases. The agency also works to educate consumers about the risks and dangers that exist from buying unsafe products.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

To view the letters,
http://www.fda.gov/foi/warning_letters/s6680c.htm - Aviralex Int.

http://www.fda.gov/foi/warning_letters/s6681c.htm - Aidance Skincare

http://www.fda.gov/foi/warning_letters/s6682c.htm - Health-science-report

http://www.fda.gov/foi/warning_letters/s6683c.htm - NeumaLife

http://www.fda.gov/foi/warning_letters/s6684c.htm - IMULUX, LLC

http://www.fda.gov/foi/warning_letters/s6685c.htm - Saferex Laboratories

http://www.fda.gov/foi/warning_letters/s6686c.htm - McKinnon, Blair