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FDA to Review Triclosan After Decades of Delay

(Beyond Pesticides, May 7, 2013) After 40 years of delay, the Associated Press reports that the U.S. Food and Drug Administration (FDA) will rule on the safety of the antibacterial chemical triclosan this year. Triclosan is present in hundreds of consumer products ranging from antibacterial soaps, deodorants, toothpastes, cosmetics, fabrics, toys, and other household and personal care products, appearing in some of these products in a formulation known as Microban. The agency’s review comes amid growing pressure from politicians and consumer advocates concerning the safety of this chemical in terms of both human health and the wider environment.

In 1972, Congress required FDA to set guidelines for many common antibacterial chemicals found in over-the-counter soaps and scrubs. FDA published tentative guidelines for chemicals used in liquid hand soaps and washes by 1978, stating triclosan was “not generally recognized as safe and effective.” This was due to a lack of scientific research demonstrating the chemical’s safety and effectiveness.

Bubbles in orange liquid soapFDA published several draft guidelines over the years but never finalized the results. This has allowed companies to keep the chemical in their products. Last summer, FDA said its triclosan review would be completed by the end of 2012. The agency then pushed back the date to February 2013. After February passed without a review, a federal appeals court in March said that a lawsuit filed by the Natural Resources Defense Council aimed at forcing FDA to complete its review could move forward. A lower court had previously tossed out the lawsuit, but the three-panel judge in March resinstated the case, noting that NRDC presented evidence that triclosan could be dangerous.

FDA is now planning to complete its review; FDA spokeswoman Stephanie Yao said the evaluation of triclosan is “one of the highest priorities” for the agency, but did not offer an explanation for the delay.

The U.S. Environmental Protection Agency (EPA) will also be reviewing the safety of triclosan this year.

Beyond Pesticides, with 15 organizations, filed a citizens petition to FDA in October 2005, requesting the agency to ban all non-medical uses of triclosan. In 2009, Beyond Pesticides, in partnership with Food and Water Watch and 80 other groups, submitted an amended petition to FDA and a new petition to EPA, citing violations of numerous federal statutes. Echoing these petitions, Rep. Ed Markey (D-MA) also submitted letters of concern to both EPA and FDA. In FDA’s response, the agency acknowledged that soaps containing triclosan offer no additional benefit over regular soap and water. FDA stated that “existing data raise valid concerns about the [health] effects of repetitive daily human exposure to these antiseptic ingredients” and announced plans to address the use of triclosan in cosmetics or other products. FDA also expressed concern about the development of antibiotic resistance from using antibacterial products and about triclosan’s potential long-term health effects.

Beyond Pesticides has provided extensive documentation of the potential human and environmental health effects of triclosan and its cousin triclocarban. Triclosan is an endocrine disruptor and has been shown to affect male and female reproductive hormones and possibly fetal development. It is also shown to alter thyroid function, and other studies have found that due to its extensive use in consumer goods, triclosan and its metabolites are present in umbilical cord blood and human milk. The U.S. Centers for Disease Control and Prevention (CDC) also found that triclosan is present in the urine of 75% of the U.S. population, with concentrations that have increased by 50% since 2004.

Last August, research from the University of California, Davis led by Dr. Issac Pessah, Ph.D., showed triclosan’s ability to impair muscle function, particularly in the heart. In the presence of triclosan, the normal communication between two proteins that function as calcium channels is impaired, causing skeletal and cardiac muscle failure. Dr. Pessah recently spoke about the health effects of triclosan at Beyond Pesticides 31st National Pesticide Forum. His speech can be viewed in part at this link.

In January of this year, a study from the University of Minnesota (UMN) revealed triclosan, along with several of its toxic breakdown products such as dioxin, to be present In freshwater lakes across Minnesota, including Lake Superior. Previous research by the team and UMN revealed triclosan’s ability to disrupt aquatic ecosystems by inhibiting photosynthesis in algae and killing beneficial bacteria.

In light of inaction at the federal level, this information spurred Minnesota Governor Mark Dayton to order state agencies to stop purchasing triclosan-containing products. “There are alternatives, and they are at the same price,” said Cathy Moeger, sustainability manager for the Minnesota’s Pollution Control Agency. “If it has an environmental benefit, why not do it?”

As Allison Aiello, Ph.D, professor at the University of Michigan’s School of Public Health (who also spoke at Beyond Pesticide 30th National Pesticide Forum), astutely notes, “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.”

Beyond Pesticides urges concerned consumers to join the ban triclosan campaign and sign the pledge  to stop using triclosan today. Read the label of personal care products in order to avoid those containing triclosan. Encourage your local schools, government agencies, and local businesses to use their buying power to go triclosan-free. Urge your municipality, school, or company to adopt the model resolution that commits to not procuring or using products containing triclosan.

To learn more about triclosan please visit Beyond Pesticides’ Antibacterial page.

Source: Associated Press

All unattributed positions and opinions in this piece are those of Beyond Pesticides.


2 Responses to “FDA to Review Triclosan After Decades of Delay”

  1. 1
    Josie Szydlowski Says:

    I was recently diagnosed with Thyroid cancer in November of 2012. I had a Thyroidectomy on January 9th, 2013. I have no cancer what so ever in my family. The more I research this chemical and the more people I talk to, I realized that this ingredient Triclosan is in many products and is not good for you. One product that I have used for years is Bath and Body Works Hand Sanitizer. I have used this product atleast 10-20 times a day for the last 10-15 years, that I can remember. Loved the product and couldn’t use it enough. It was an obsession. You can ask anyone who knows me. Bath and Body Works recently decided to no longer sell the hand sanitizier. I’m not sure why. I truely believe that this chemical had something to do with my diagnosis of Thyroid Cancer. I will continue to research it and hope that it will be baned from all products. I would love to hear back from someone concerning this.

  2. 2
    luke bieniek Says:

    Seems to me this issue is as ripe as agent orange, tobacco, asbestos, etc etc etc. The inaction of the fda is reprehensible. A class action suit against any & all who are directly or indirectly associated with the perpetration of this atrosity, including the fda, must be pursued initiated petioned on in & of upside down & retractively immediately. This is inexcusable.

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