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FDA Still Dragging Feet on Triclosan

Aug 22, 2011 | Parker Waichman LLP
FDA Still Dragging Feet on Triclosan

Proposal To Regulate Triclosan Under Study

Nearly 30 years since it first proposed regulating triclosan, the U.S. Food & Drug Administration (FDA) is still far from reaching a decision.  The agency was expected to release the findings of its triclosan review several months ago, but according to a New York Times report, is delaying the release until 2012.

Triclosan, developed 40 years ago as a surgical scrub, can now be found in  a host of consumer products, from hand wash, to toothpaste, to cutting boards.  It can also be found in human beings: A survey by the Centers for Disease Control and Prevention found the chemical present in the urine of 75 percent of Americans over the age of 5. 

Dial Complete Antibacterial Foaming Antibacterial Handwash is among the many consumer products that contain triclosan.   The makers of that handwash claim that triclosan enables it to kill more germs than similar products.  But some consumers have taken issue with those claims, alleging in lawsuits that they are not backed by any serious scientific studies.  Those lawsuits also allege that triclosan has been linked to antibiotic resistance. Just last week, 10 Dial Complete lawsuits filed in federal courts around the country were consolidated in a multidistrict litigation and transferred to U.S. District Court, District of New Hampshire.

Triclosan May Cause Antibiotic Resistance

Consumer advocates say fears about triclosan are well-founded.  According to the Times, several studies have indicated that the chemical may alter hormone regulation in laboratory animals or cause antibiotic resistance. Last year, Representative Edward J. Markey (D-Mass.) pressured the FDA to write regulations for antiseptic products like hand soap, including those that use triclosan, and pushed the agency to ban its use in consumer products.  That same year, the National Resources Defense Council sued the FDA, in an attempt to force it to finish its triclosan review.

But it appears the agency has not been moved by that pressure.  Since it first proposed regulating triclosan in 1972, it has done little other than issue statements that indicate triclosan is not all its promoters claim it should be.   In 1978, for example,  the FDA proposed eliminating triclosan as an active ingredient in hospital scrubs and in hand soaps, and  it issued a similar proposal in 1994.  But on both occassions, nothing happened.

In 2005, the FDA concluded that antimicrobial soaps and sanitizers do not reduce the risk of illness and infection in the home.  Then, in an April 8, 2010 “Consumer Update”, the FDA stated that it does not have evidence that triclosan-containing antibacterial soaps and body washes provide any extra health benefit over soap and water alone.  

In the 2010 Consumer Update, the FDA said it would communicate its findings by spring of 2011.   So far, it's said nothing.  According to a report on the National Resources Defense Council's staff blog, Switchboard, the FDA recently edited its triclosan page on its website to say that it would communicate its findings in the winter, 2012 (here’s a link to the page last year, and here’s a link to the webpage from today.) 

The agency has not given any reason for the delay, Switchboard said, or provided any type of update about its ongoing triclosan review.

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