Dangerous Chemical in Soaps and Toothpaste Facing Closer Scrutiny

WASHINGTON (December 16, 2013) – Acting under pressure from a Natural Resources Defense Council lawsuit, the U.S  Food and Drug Administration today proposed a federal rule that, if finalized, would remove the potentially hazardous chemical triclosan from consumer body washes and hand soaps.

“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney in NRDC’s health program. “FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.”

This is just one of NRDC’s ongoing efforts to protect consumers from harm by forcing the removal of triclosan from the marketplace. The chemical, a suspected endocrine disruptor, has been linked to reproductive and developmental harm in laboratory studies.

FDA first proposed to remove triclosan from certain consumer products in 1978. But because the agency took no final action, triclosan has been found in more and more soaps. In 2010, NRDC sued FDA to force the agency to issue a final rule. As part of a settlement signed last month, the agency proposed a new final rule today and committed to taking final action by 2016.

Under its proposed rule released today, FDA will require manufacturers to prove that their antibacterial soaps and body washes are safe and more effective than plain soap and water. If companies cannot demonstrate the safety and effectiveness of their products, they would have to be reformulated, relabeled or possibly removed from the market.

Separately, on December 4, NRDC filed a new lawsuit against the FDA seeking to obtain records the agency has withheld about possible health risks of triclosan added to toothpaste.

In December 2012, NRDC requested records about the FDA’s 1997 approval of Colgate Total, which includes triclosan. On January 23, 2013, FDA, in response to NRDC’s request, released a significantly redacted subset of the records sought, which apparently included titles, authors and subjects of toxicology studies on which FDA based its approval of triclosan in toothpaste.

The agency refused to release the blacked out documents, which prompted NRDC’s lawsuit, filed in the U.S. District Court for the Southern District of New York. It asserts that the FDA has violated the Freedom of Information Act by failing to provide a complete version of the toxicology information relied on by the agency to approve the sale of the toothpaste to the public. “Scientific studies have linked triclosan to multiple health hazards,” including disrupting hormones that regulate brain and reproductive functions, says the complaint.

“The public needs to see testing data, hidden by the FDA, in order to determine what product is safe for them to brush their teeth with,” said Wu. “It’s a basic right-to-know consumer protection issue.”

The growing use of triclosan in products over the past few decades has led to widespread residues in the environment and in people. Bio-monitoring results found residues of triclosan in 75 percent of Americans over the age of six. The chemical is absorbed through contact with the skin and tests have found it in human blood, urine and even breast milk.

Laboratory studies have shown that triclosan is an endocrine disruptor 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 also may contribute to the development of antibiotic-resistant bacteria, may exacerbate allergies, and may weaken muscle function.