[Pharmwaste] Safety Of Triclosan In Toothpaste Questioned, and Colgate-Palmolive Removed This Potentially Harmful Chemical From Its Soap Products - But It's Still In Your Toothpaste

[DeBiasi, Deborah (DEQ)]

http://cen.acs.org/articles/92/i33/Safety-Triclosan-Toothpaste-Questioned.html

Safety Of Triclosan In Toothpaste Questioned
Personal Care: Experts, advocates scrutinize industry safety data on antibacterial chemical
By Britt E. Erickson<http://cen.acs.org/static/about/staff_landing/biobee.html>
Department: Government & Policy<http://cen.acs.org/departments/government.html>
News Channels: Environmental SCENE<http://cen.acs.org/news/enviroscene.html>
Keywords: triclosan<http://pubs.acs.org/iapps/wld/cen/results.html?line3=triclosan>, antibacterial<http://pubs.acs.org/iapps/wld/cen/results.html?line3=antibacterial>, toothpaste<http://pubs.acs.org/iapps/wld/cen/results.html?line3=toothpaste>
The Food & Drug Administration<http://www.fda.gov> ignored red flags in industry safety data that it relied on when approving the antibacterial triclosan for use in toothpaste, say some scientists and an environmental group.
FDA recently released those data, which it had withheld since 1997 when it approved triclosan in toothpaste<http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020231_total_toc.cfm>. The agency did so in response to a lawsuit filed by the Natural Resources Defense Council<http://www.nrdc.org/> (NRDC), an activist group. The data show a link between triclosan exposure and fetal bone malformation in animals.
Colgate<http://www.colgatetotal.com/home>, the only company that sells toothpaste containing triclosan in the U.S., says the findings are irrelevant to human health. Triclosan is "safe and effective for treating gingivitis," the firm says.
But experts say the data should have alerted FDA that triclosan is a potential endocrine disruptor.
"A growing body of evidence shows that triclosan can lead to developmental and reproductive problems in animals and potentially in humans," says Benny Pycke<https://labs.biodesign.asu.edu/halden/people>, a scientist at Arizona State University. Pycke presented new research at a meeting of the American Chemical Society<http://www.acs.org/content/acs/en/meetings/fall-2014.html> last week showing that pregnant women and their fetuses are exposed to the chemical.
NRDC is now asking FDA for the latest data on the safety of triclosan in toothpaste and on adverse events associated with the chemical. Colgate reports such information to FDA annually. But the public is unlikely to see it anytime soon because FDA told NRDC it would take up to two years to look into the request, an NRDC attorney says.
Chemical & Engineering News
ISSN 0009-2347
Copyright (c) 2014 American Chemical Society



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http://www.businessinsider.in/Colgate-Palmolive-Removed-This-Potentially-Harmful-Chemical-From-Its-Soap-Products--But-Its-Still-In-Your-Toothpaste/articleshow/40076995.cms

Colgate-Palmolive Removed This Potentially Harmful Chemical From Its Soap Products - But It's Still In Your Toothpaste
Katie Jennings<http://www.businessinsider.com/author/katie-jennings?IR=C>0 Aug 12, 2014, 02.21 AM

Flickr/Cody Long<https://www.flickr.com/photos/shakestercody/469705643>
In 2011, Colgate-Palmolive removed a chemical called triclosan from its soap products, citing "changing consumer preferences.<http://www.nytimes.com/2011/08/20/business/triclosan-an-antibacterial-chemical-in-consumer-products-raises-safety-issues.html?pagewanted=all>" But according to a New York Times article<http://www.nytimes.com/2011/08/20/business/triclosan-an-antibacterial-chemical-in-consumer-products-raises-safety-issues.html?pagewanted=all>, the change was more likely motivated by concerns raised by consumer groups and Congressional leaders over the potentially harmful effects of the chemical.
While long-term research in humans is lacking, several studies of the effects of triclosan in mice, rats and frogs, found reduced fertility<http://bigstory.ap.org/article/decade-old-question-antibacterial-soap-safe>, development issues in fetuses<http://toxsci.oxfordjournals.org/content/119/2/417.short>, and increased cancer risk<http://pubs.acs.org/doi/abs/10.1021/tx5000156>.
However, triclosan still remains an active ingredient in Colgate Total, the company's number one selling toothpaste. Why is a product that may not be safe for our hands still in a product that goes into our mouths?
The Role of the FDA
A Bloomberg News investigation<http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html> places some of the blame on the U.S. Food and Drug Administration approval process, highlighting 35 pages of recently released toxicology data from the approval application for Colgate Total. Those pages show that there may have been some red flags about triclosan's safety that the FDA should have examined further.
For instance, the application included a study that found "fetal bone malformations in mice and rats.<http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html>" It is important to recognize that chemicals can affect animals differently than humans, especially because animal testing can involve sky-high doses of the chemical in question. However, often these kinds of findings in animals mean further testing is warranted before the product is approved for humans.
Another issue is that the FDA "relies on company-backed science to show products are safe and effective," according to the Bloomberg story<http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html>. This means that instead of having independent, third-party researchers determine the effectiveness and safety of a given product, the FDA often accepts research studies funded by the company that is trying to seek approval.
Triclosan is an antimicrobial agent, meaning that it helps to "slow or stop the growth of bacteria, fungi, and mildew," according to the Environmental Protection Agency<http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm>. It first started to appear in antibacterial hand soap products in the 1970s.
The FDA has never issued a comprehensive ruling on triclosan's effectiveness and safety - even though it originally said it would look into triclosan in 1974. That was two years before "the U.S. Toxic Substances Control Act of 1976, which aimed to comprehensively regulate chemicals, grandfathered in existing substances with no safety testing," Bloomberg notes<http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html>. Now the FDA says it will issue a ruling on triclosan in 2016.
While companies have an obligation to the safety and health of their customers, they can also have a lot of money riding on the approval of a new product.
The Risks and Benefits of Triclosan
When it comes to consumer safety, the FDA needs to determine whether the benefits of a product outweigh the risks. In the case of toothpaste, clinical trials showed that triclosan helped fight plaque germs found in the mouth, reducing the individual's risk of gingivitis, a common gum disease.
According to the company website<http://www.colgatetotal.com/triclosan-faq>, "Colgate Total is clinically proven to work better than other toothpastes to reduce these germs that can cause the gum disease gingivitis." Colgate's website also states that the "safety and effectiveness" of the product is supported by more than 80 scientific studies, involving 19,000 people.
Last year, an independent review of the existing research on triclosan in toothpaste<http://www.ncbi.nlm.nih.gov/pubmed/24310847> concluded that the chemical "reduced plaque, gingival inflammation and gingival bleeding" but that those reductions "may or may not be clinically important." Triclosan was also associated with a "small reduction" in cavities.
"There do not appear to be any serious safety concerns regarding the use of triclosan... toothpastes in studies up to three years in duration," the reviewers concluded.
Colgate is quick to point out that real-world evidence seems to echo these results.
"In the nearly 18 years that Colgate Total has been on the market in the U.S., there has been no signal of a safety issue from adverse-event reports," Thomas DiPiazza, a Colgate spokesperson told Bloomberg.<http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html> (We have reached out to Colgate for further comment and will update this post if we hear back.)
Still, given the questions raised by animals studies, this kind of logic - that triclosan isn't harmful because ill effects haven't been reported in humans yet - doesn't cut it for the Natural Resources Defense Council, or NRDC. The nonprofit environmental organization has actively been involved<http://www.nrdc.org/media/2013/131216.asp> in educating consumers about triclosan's potential risks and also pressuring the government to take action.
It was a Freedom of Information Act request from the NRDC that led to the release of the FDA approval documents for Colgate Total.
The NRDC's position: Is even a small potential risk worth it, when the benefits seem to be small-to-none?
The organization has focused on hand soap and toothpaste because those products are required to list triclosan in the ingredient lists. In many other products, it may simply fall under the label "preservative."
"It's also used in other products that you wouldn't normally think of - cutting boards and shoes and shopping carts and bath tubs," Mae Wu, an attorney for the NRDC Health Program told Business Insider. "It's hard to avoid it."
On its website, the NRDC tells consumers<http://www.nrdc.org/living/chemicalindex/triclosan.asp> to "urge the FDA to pull products containing triclosan...from store shelves in order to protect public health."
Ultimately, the FDA ruling in 2016 will determine whether increased regulation is on the way.


Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov<http://www.deq.virginia.gov/>
Virginia Department of Environmental Quality
Office of Water Permits
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program
PPCPs, EDCs, and Microconstituents
http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx
Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028      FAX:      804-698-4032

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