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 safety and effectiveness of Colgate Total® with triclosan.
Safety Reviews by Regulators around the World
The U.S. Food and Drug Administration (FDA), leading health regulatory agencies around the world, and other independent sources have reviewed and confirmed triclosan's safe and effective use in Colgate Total® toothpaste.
Colgate Total®, with its active ingredient triclosan, has been approved as safe and effective by the U.S. Food and Drug Administration (FDA) via its rigorous New Drug Application (NDA) process. This is the same process used by the FDA to approve prescription medications, and Colgate Total® is the only toothpaste on the market that has undergone the FDA's NDA review process. The NDA approval 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 FDA's NDA approval also requires ongoing monitoring and updating, and we regularly provide the FDA with safety updates.
On September 2, 2016, the FDA issued a 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 do 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.
For more information about how New Drug Applications get approved by FDA and how products obtain the ADA's Seal of Acceptance, please click here. For additional information regarding triclosan and the FDA, click here.
Independent scientific committees of the European Commission have also evaluated 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. The European Chemicals Agency (ECHA) is conducting a review of triclosan under the REACH regulation and determined that additional studies are necessary to complete its assessment regarding potential endocrine effects and persistence in the environment. This determination is currently under review. In a separate review under the Biocides Regulation, ECHA determined that the sale of surgical hand scrubs containing a significantly higher level of triclosan are to be phased out as of January 2018. ECHA's action under the EU Biocide regulation does not impact the continued sale of Colgate Total as a cosmetic toothpaste under the EU Cosmetic Regulation.
In addition to US FDA and the EU Commission reviews, the two EU medicinal authorities who have reviewed Colgate Total® with triclosan, the UK & Irish Medicinal Authorities (MHRA and HPRA), have both approved it as a safe and effective medicinal toothpaste, as have the comparable health authorities in Canada, Australia, and New Zealand.
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 safety and effectiveness of Colgate Total®.