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19
Aug

FDA Questioned Triclosan’s Safety in Colgate’s Total Toothpaste in 90’s

(Beyond Pesticides, August 19, 2014) Newly released documents from the U.S. Food and Drug Administration (FDA) reveals that regulators expressed concerns over the safety of triclosan in Colgate Total toothpaste during the product’s registration in the mid-1990s. This information was provided to the public by FDA after a Freedom of Information Act request by the Natural Resources Defense Council (NRDC), and was posted on the agency’s website after inquiries from Bloomberg News. In addition to health effects previously identified by Beyond Pesticides, these documents raise concerns about the use of triclosan as an anti-gingivitis agent in toothpaste; a use which is not currently under scrutiny as FDA conducts its long-awaited health review of the chemical.

Although FDA is requiring manufacturers of triclosan-containing soaps to prove that their products are not hazardous to humans and more effective than regular soap and water, triclosan formulated in toothpaste was not subject to a similar requirement as FDA had indicated that the chemical is effective as an anti-gingivitis agent. Colgate Total is the only brand of toothpaste on the market that still contains triclosan; GlaxoSmithKline, producer of Aquafresh and Sensodyne, removed triclosan from its toothpaste in 2009. And a focus on safer products seems to be paying off. Last year, as Colgate Total lost 2% of its market share, the company’s natural Tom’s of Maine brand grew 14%. Crest, maker of the top selling 3D White and Pro-Health brands, specifically advertises its toothpastes as triclosan-free.

FDA documents reveal that regulators considered the initial carcinogenicity studies conducted by Colgate to be insufficient, and requested further data and research. Following an inquiry from Bloomberg News, the agency released the supplemental 1997 cancer study requested of Colgate. However, concerns still remain over whether the agency’s requests and Colgate’s data were as thorough as they should have been. David Kessler, M.D, an FDA commissioner from 1990-1997, noted to Bloomberg News, “The real question is did Colgate do a good job.”

Another issue within the documents was developmental studies that showed malformed paw bones and skulls in the fetal offspring of rats, as well as lower weight fetuses. These effects were cited as incidental in the documents, and attributed to maternal, rather than fetal toxicity. In light of recent scientific data on the health effects of triclosan, many are criticizing the agency’s determination and chastising it for not releasing this data sooner. “Wow. They kept that private?” said Thomas Zoeller, PhD, of the University of Massachusetts to Bloomberg News. “The distinction between maternal and fetal toxicity is an excuse to do nothing. And it’s not scientifically justifiable.” Disclosing these results may have been helpful in alerting scientists to the endocrine disrupting properties of triclosan.

This data also highlights a pervasive problem with chemical regulation in the U.S.; specifically, the government’s reliance on industry-funded studies in order to assess the safety of chemicals. The long, expensive process of registering a new drug or pesticide often requires years of time and tens of thousands of dollars. The high monetary and temporal requirements needed to register a chemical can lead regulators to dismiss independent science that raises safety concerns (chemical mixtures, synergistic effects, certain health endpoints such as endocrine disruption, disproportionate effects to vulnerable population groups) not accounted for during regulatory decision-making. In an age where the adverse effects of safety-tested chemicals have been widely and increasingly documented, Beyond Pesticides supports an alternative approach that first asks whether there is a less toxic way of achieving a chemical’s intended purpose. The Fund for Independent Science was launched last year to support the continual understanding of the destructive capacity of toxic materials, and sustainable practices that can replace them in the marketplace.

The health and environmental effects of triclosan reveal a laundry list of concerns, ranging from body burden to endocrine disruption, cancer, impacts on fetal development, bacterial resistance, impaired muscle functioning, persistence in the environment, and adverse changes in biotic communities. Although FDA indicates that the agency will release a determination concerning triclosan-containing soaps by 2016, the agency indicated to Bloomberg News that it will only reexamine the registration of Total if concerns are found during the broader review process.

In the meantime, concerned consumers can join the ban triclosan campaign and sign the pledge to stop using triclosan today. Consider a clean sweep of all products in your house, school, and office that contain triclosan. A non-comprehensive list of triclosan-containing products is available here for reference, but the best way to find out if triclosan is present is to read the label. Encourage your local schools, government agencies, and businesses to use their buying power to go triclosan-free. Urge your municipality, school, or company to follow the lead of Minnesota by banning triclosan; organizations can adopt the model resolution which commits to not procuring or using products containing triclosan.

Source: Bloomberg News

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