Group Sues FDA Over Triclosan Regulation

The Natural Resources Defense Council (NRDC) says it has filed a lawsuit against the Food and Drug Administration (FDA) for failing to issue a final rule regulating the chemicals triclosan and triclocarban, which are commonly found in antibacterial soaps. These chemicals are suspected endocrine disruptors linked to reproductive and developmental harm in laboratory studies. NRDC filed todays lawsuit in the U.S. District Court for the Southern District of New York.

"Washing your hands with so-called antibacterial soap containing triclosan or triclocarban actually does nothing different than using regular soap and water," says Jennifer Sass, a senior scientist in the Health and Environment Program at NRDC. "Using soap containing these chemicals does not provide an additional benefit as consumers might think, but instead actually comes with potential health risks. The FDA needs to prohibit these harmful chemicals from being put into products in the first place."

The majority of consumer soaps claiming to be "antibacterial" or "antimicrobial" contain the chemicals triclosan or triclocarban. FDA first proposed a rule that would have removed these chemicals from soaps in 1978. Until this rule is finalized, the NRDC says, these chemicals can be widely used with no regulatory oversight -- despite evidence that they are not effective and numerous studies associate them with serious health risks. The growing use of these chemicals in products has led to widespread residues in the environment and in people; recent bio-monitoring results found residues of triclosan in 75 percent of Americans over the age of six. The chemicals are absorbed through contact with the skin and tests have found them in human blood, urine and even breast milk.

The NRDC says that laboratory studies have shown that these chemicals are endocrine-disruptors capable of interfering with hormones critical for normal development and reproduction. Such hormonal interference has the potential to cause long-term health problems including poor sperm quality and infertility, and damage to the developing brain leading to poor learning and memory. Several studies suggest that triclosan and triclocarban also may contribute to the development of antibiotic resistant bacteria.

In April, the FDA acknowledged soaps containing triclosan offer no additional benefit over regular soap and water. The FDA also expressed concern about the development of antibiotic resistance from using antibacterial products and about triclosans potential long-term health effects, but did not move ahead on the rule-making.

"Three decades of delay is outrageous," says Avinash Kar, an attorney with NRDC. "FDA needs to issue a final rule on triclosan and triclocarban now, and that rule should ban both chemicals in hand soaps."

The lawsuit asks the court to impose a strict deadline for FDA to finalize the rule, which has been pending for 32 years. Under FDAs current proposal, the rule would ban the continued use of triclosan and triclocarban in many antibacterial products.