SAFETY OF COLGATE* TOTAL* TOOTHPASTE WITH TRICLOSAN
Colgate* recognizes the importance of continuous scientific study. We conduct and commission research, publish papers, closely investigate newly published information, and actively participate in expert symposia on an ongoing basis. We remain confident that ongoing independent scientific reviews will continue to add to the substantial body of research that affirms the effectiveness of Colgate* Total* toothpaste with triclosan and its safety for human health.
Safety reviews of triclosan in toothpaste by regulators around the world
The Government of Canada, in providing information about triclosan, has stated: “Triclosan does not pose a health risk to most Canadians, including children, pregnant women, and seniors. The levels of triclosan to which we are exposed are considered too low to be harmful.”
Colgate* Total*, with its active ingredient triclosan, has gone through the rigorous Canadian New Drug Submission (NDS) process, the same process used to license prescription medications for sale in Canada. The NDS process requires a comprehensive evaluation of human safety. All new drug assessments include a review of nonclinical studies covering a wide array of toxicological endpoints such as carcinogenicity, reproductive and developmental toxicity, eye and skin irritation, and short term and long term toxicity.
The U.S. Food and Drug Administration (FDA), leading health regulatory agencies around the world, and other independent sources have also reviewed and confirmed triclosan's safe and effective use in Colgate* Total* toothpaste.
On September 6, 2016, the FDA published its final rule on consumer antibacterial hand soaps, that prohibits the continued use of triclosan and 18 other antibacterial ingredients, as of September 6, 2017. The FDA concluded that soap manufacturers had not submitted adequate safety evidence for use in these products; the agency did not conclude that triclosan in soap is unsafe. The FDA's rule with respect to consumer antibacterial hand soaps does not impact Colgate* Total's* NDA approval, which has not changed.
Colgate* Total* is also the only toothpaste that is both approved by the FDA and accepted by the American Dental Association as safe and effective in helping to prevent gingivitis. Colgate* Total* is also recognized by the Canadian Dental Association.
Independent scientific committees of the European Commission have also evaluated the safety of triclosan several times (the Scientific Committee on Cosmetic Products and Non-food Products in 2002, the Scientific Committee on Consumer Products in 2002 and 2006, and the Scientific Committee on Consumer Safety in 2011.) Each concluded that triclosan use at 0.3% in toothpaste, the level found in Colgate* Total*, is considered safe. Accordingly, an April 2014 amendment to the EU Cosmetic Regulation confirmed triclosan's continued use in cosmetic toothpastes up to the approved 0.3% level. In addition to US FDA and the EU Commission reviews, the two EU medicinal authorities who have reviewed Colgate* Total* with triclosan, the UK and Irish Medicinal Authorities (MHRA and HPRA), have both approved it as a safe and effective medicinal toothpaste, as have the comparable health authorities in Australia, and New Zealand.
In addition, Canadian health and environmental authorities finalized a review of triclosan in November 2016. The review found that triclosan exposure from all sources did not pose a risk to human health in Canada.
We will continue to share scientific research with regulatory bodies responsible for public health around the world, and remain confident that ongoing independent scientific reviews will continue to add to the substantial body of research that affirms the human safety and effectiveness of Colgate* Total*.