You Can Be Confident Using & Recommending Colgate Total®
- Colgate Total® is the #1 toothpaste recommended by dental professionals in the USA and globally.
- Colgate Total® is accepted by the ADA and over 40 dental associations worldwide.
- Colgate Total® is the only toothpaste approved through the FDA new drug application process.
- Colgate Total® is proven safe and effective.
- The safety of Colgate Total® has been affirmed by ongoing rigorous review by the FDA and regulators in the EU, Australia, Canada and other countries.
- Specifically, reports that triclosan in Colgate Total® presents a risk of cancer or endocrine disruption are not true.
Safety and Efficacy Affirmed by Regulators Around the World
Colgate's priority is for the health of your patients and our consumers. A large body of evidence supports that not only is triclosan safe for use in Colgate Total®, but also it plays an important role in maintaining oral health.
Colgate Total® users and recommenders can be confident in the safety of Colgate Total® and the distinctive health benefit it provides in fighting plaque and gingivitis.
- Colgate Total® is one of the most extensively tested and reviewed toothpastes in the world and has been approved for use by the FDA since 1997.
- Colgate Total® is the only toothpaste approved through the FDA's rigorous new drug application process, the same process used to review the safety of prescription drugs.
- In addition to the FDA, regulatory bodies in Europe, Australia and Canada, as well as other countries, affirm the safety and effectiveness of Colgate Total® in fighting gingivitis, a significant oral health condition globally.
- An article published August 11 in the United States and subsequent follow-up press stories have unfairly questioned the US FDA's safety review of Colgate Total®. However, the full body of rigorous scientific research concludes that Colgate Total® poses no cancer risk. Further, the study findings relevant to the safety of triclosan cited in the 35 pages mentioned in the article have been in the public domain well before their recent release by the FDA.
Colgate Total® is the Most Reviewed Toothpaste in the World
There are more published peer-reviewed clinical studies of Colgate Total® than of any other toothpaste in the world.
- The safety and efficacy of Colgate Total® is supported by more than 90 clinical studies, involving 20,000 people, as well as by a broad set of safety evaluations.
Extensive, scientific evidence was provided to the FDA in the original application process more than 20 years ago involving 96 volumes 250+ more pages in length.
In addition, annual reports are provided to the FDA regarding new information around the formula, new clinical efficacy studies and any new safety data that has emerged in that year that could impact the safety of the product.
Ongoing Safety Monitoring
We continually monitor, analyze and address scientific studies to ensure safety and efficacy.
- A recent five-year clinical study, published in 2012, also affirms the safety of Colgate Total®.
- Our research is shared with regulatory agencies in the United States, Australia, Canada and Europe. All have conducted their own reviews of triclosan, and in every case, they have affirmed triclosan's continued safe use in toothpaste.
- Colgate regularly publishes its research findings in peer-reviewed journals to advance scientific knowledge and understanding of our product and its key ingredients.
- New third-party scientific literature is also extensively reviewed.
- If the Company is notified or aware of any serious adverse events, it must be reported immediately to the FDA. All adverse events must be monitored for trends as part of a signal detection process. In the nearly 18 years that Colgate Total® has been on the market in the United States, there has been no signal of a safety issue from adverse event reports.
Extensive Studies Show That Use of Colgate Total® Poses No Cancer Risk
Every regulatory agency, including the EPA and regulatory agencies around the world, that has reviewed the safety of triclosan, including it's use in Colgate Total®, has concluded based on the evidence that there is no cancer risk for humans.
These reviews have included:
- US EPA, Cancer Assessment Review Committee, 2005
- Australian Industrial Chemicals Notification and Assessment Scheme, 2009
- European Commission, Scientific Committee on Consumer Products, 2009
- US FDA, UK MHRA< Irish HPRA, Health Canada, Australian & New Zealand TGA
An article published August 11 in the United States and subsequent follow-up press stories have unfairly questioned the US FDA's safety review of Colgate Total®. However, the full body of rigorous scientific research concludes that Colgate Total® poses no cancer risk. Further, the study findings relevant to the safety of triclosan cited in the 35 pages mentioned in the article have been in the public domain well before their recent release by the FDA.
Extensive Studies Show That Use of Colgate Total® Poses No Endocrine Risk
Claims that triclosan is an endocrine disruptor are not true.
- The World Health Organization's definition of endocrine disruptor makes clear that any endocrine effect produced must be harmful to health.
- The weight of scientific evidence in multiple studies in multiple species have detected no growth, development or reproductive adverse effects.
- Not a single study has documented adverse human health outcomes from the use of triclosan in toothpaste. The data include a 4-year clinical study that showed no detectable effects of triclosan toothpaste on thyroid function.
Colgate Total® is Proven Effective
In contrast to the lack of validated evidence linking animal studies to human health risks there is a wealth of scientific evidence linking Colgate Total® to the prevention of gingivitis, a real and significant oral health condition for over 75% of American adults.
- Colgate Total® is clinically proven to work better than other toothpastes in reducing the germs that can cause gum disease.
- More than 90 peer-reviewed scientific studies affirm its efficacy and safety.
Most recently, a thorough independent review was conducted by the Cochrane Oral Health Group on the oral health benefits of triclosan/copolymer, the active antibacterial system in Colgate Total® toothpaste. The Cochrane Review evaluated 30 studies dating from 1990 to 2012 and involving 14,835 participants. The resulting data highlighted the many clinical benefits of using a fluoride toothpaste containing triclosan/copolymer and concluded there was no evidence of any harmful effects associated with the use of triclosan/copolymer toothpastes in studies up to three years in duration. Among other things, the Cochrane Review found that after six or more months of use, fluoride toothpaste containing triclosan/copolymer provided:
- 22% reduction in plaque and gingivitis as compared with traditional fluoride toothpaste.
- 41% reduction in plaque severity as compared with traditional fluoride toothpaste.
- 48% reduction in gum bleeding as compared with traditional fluoride toothpaste.
You Can Be Confident Recommending Colgate Total®
Colgate's priority is the safety of our products. Colgate Total® users and recommenders can be confident in the safety of Colgate Total® and the distinctive health benefit it provides in fighting plaque and gingivitis.We recognize the importance of ongoing scientific study, closely investigate new information, and conduct research on an ongoing basis. We remain confident that ongoing independent reviews will continue to add to the substantial body of research that affirms the effectiveness and safety of triclosan in Colgate Total®.