FDA Pressured On Triclosan Decision
May 6, 2013

Pressure Mounts For FDA Decision On Safety Of Triclosan

Alan McStravick for redOrbit.com - Your Universe Online

For the past four decades, the antibacterial and antifungal agent triclosan has become a ubiquitous ingredient in products like hand soaps, deodorant, cosmetics and even toothpaste.  And while it has been a part of our lives for over 40 years, only now are federal regulators reviewing the efficacy and safety of the synthetic chemical. An FDA decision expected later this year will determine whether manufacturers will be able to continue using triclosan in a variety of personal care products. The triclosan industry is estimated to be valued at $1 billion.

After promising a decision in the summer of 2012 and again in February of this year, the FDA now finds itself under mounting pressure by lawmakers and consumer advocate groups. Each group, concerned about the safety of triclosan, refers to recent animal studies that highlight potential links between triclosan and an increased risk of infertility, early onset of puberty and other hormone-related problems.

Allison Aiello, professor at the University of Michigan´s School of Public Health stated, “To me it looks like the risks outweigh any benefit associated with these products right now. At this point, it´s just looking like a superfluous chemical.”

The only thing that could be considered worse than this chemical being ineffective and therefore unnecessary would be if it actually turned out to pose a severe health and environmental risk. Unfortunately, much evidence is pointing to exactly that. When we wash the chemical off our skin in our sinks and showers, it runs off into our water supply, through tributary and river systems and, ultimately, into our oceans. In these marine ecosystems, the chemical kills the microscopic bacteria that form the base of the food chain. Trace amounts of the chemical have been found throughout the ocean food chain, showing up even in dolphins.

For many, one of the biggest issues of concern beyond the potential dangers of the chemical itself is that the FDA hasn´t presented a scientific review of triclosan in more than four decades. The slow but deliberate pace of the FDA is not a new trait of the department. In 1972 Congress passed the initial law charging the FDA with setting guidelines for the use of antibacterial chemicals in over-the-counter hygiene products. However, it was another six years before the administration published their first tentative guidelines on the chemicals. And even by 1978, the draft stated triclosan was “not generally recognized as safe and effective.”

Despite the subsequent publication of several revisions of the guidelines, the agency never finalized the results. As a result, companies have not had to remove triclosan from their products.

Consumer advocacy and other outside groups have kept pressure on the FDA, however. In fact, this past March, a federal appeals court stated a lawsuit filed by the nonprofit Natural Resources Defense council could proceed. The lawsuit is specifically aimed at forcing the FDA to complete their review. The appeals court overturned a lower court´s decision, stating that the nonprofit group presented sufficient evidence to indicate that triclosan could potentially be dangerous.

The FDA´s own website states “the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.” As a cleaning agent, triclosan is most effective after two minutes of continued washing. As most people spend less than 30 seconds scrubbing and rinsing, triclosan may provide no benefit for general washing.

Representative Edward Markey of Massachusetts is one of several members of Congress who is unhappy with the length of time the FDA has taken to prepare and present their review. “When the FDA first started evaluating the rules governing triclosan´s use, Richard Nixon was still president,” noted Markey. The democratic congressman specifically requested the FDA take a closer look at the chemical after its use in products that could come into contact with food was banned by the European Union.

"I think the FDA is behind the curve," said Dr. Andrea Gore of the University of Texas at Austin, lead author of an Endocrine Society statement on hormone disrupting chemicals. "At what point do you draw a line and say we need to take this out of products that are being applied to our skin? What is enough evidence?"

The early use of triclosan was initially intended for hospitals. Its antibacterial qualities were viewed as effective in prepping surgical materials as well as coating the surfaces of catheters and stitches.

It wasn´t until the 1990s that the chemical made the transition from almost strict hospital use to near-ubiquity in general consumer products like soap, socks and lunchboxes. As our society has adopted a near obsessive desire to live germ-free, the use of this product in everyday products has skyrocketed.

While the FDA has seemingly been derelict in their duties, several universities took up the task of testing triclosan. In 2007, a study compiled data from over 30 individual studies looking at the use of antibacterial soaps. They were able to show that soaps containing the chemical were no more effective at preventing illness or reducing bacteria on the hands than plain soap.

Adding insult to injury, a growing number of health experts contend that the routine use of chemicals like triclosan is in part responsible for the surge of resistant superbugs witnessed in recent years. In laboratory experiments, it has been noted that new antibiotic-resistant strains of E. coli and other bacteria can now grow thriving cultures in environments with high levels of the antibacterial chemical.

Even in the absence of specific FDA guidelines, an increasing number of medical societies, hospitals and healthcare companies have started to abandon the use of products containing triclosan.