Among oral care products available in the United States, triclosan is found in Colgate Total® toothpaste. To market Colgate Total® in the United States, the Food and Drug Administration (FDA) required Colgate to submit a New Drug Application (NDA). Colgate Total® toothpaste was approved in 1997 as safe and effective by the FDA under the Food, Drug and Cosmetic Act.1 Because Colgate Total® toothpaste is regulated as a drug by the FDA, safety data is continuously monitored, just as it is for any other approved drug that is available on the market.
The FDA continues to support the efficacy and safety of Colgate Total® with triclosan. In a briefing for reporters conducted Dec. 16, 2013, Dr. Sandy Kweder, Deputy Director in the Office of New Drugs, FDA Center for Drug Evaluation and Research, affirmed the agency's view that Colgate Total® is safe and effective:
"Triclosan in toothpaste has been shown to be effective in preventing gingivitis that's caused by bacteria in the mouth. Gingivitis can really wreak havoc with people's teeth. And, they have done studies to show that use of Triclosan in that setting is safe and effective."
The full transcript of the FDA media briefing, including the comments on Colgate Total® (see page 10 of the transcript), is available on the FDA website at: http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM378989.pdf
Numerous other regulatory agencies around the world also have reviewed the safety and efficacy data surrounding use of triclosan in various consumer products and cosmetics.1-6 Together, these reviews confirm the safety of using triclosan where a health benefit has been demonstrated, as with dentifrice use to improve oral health.
More than 80 published clinical trials involving over 19,000 subjects have evaluated the safety and efficacy of Colgate Total® toothpaste, making it the most widely studied toothpaste in the world. These findings have been confirmed in numerous published meta-analyses and systematic reviews. 7-12
Colgate Total® toothpaste has obtained the ADA Seal of Acceptance based upon data obtained from longitudinal studies meeting rigorous scientific criteria, including criteria that require the investigators to document any safety issues that arise with long-term use.13 Dental associations in 30 countries also have granted their seal of approval to this dentifrice.
Triclosan is a broad-spectrum antimicrobial agent that effectively reduces both supragingival plaque and gingivitis. It kills bacteria through a variety of pharmacological effects, including lysis of the organism. Concerns about the promotion of microbial resistance are unfounded, as use of triclosan has never been shown to promote microbial resistance in any household or clinical environment.2-4,14 Long-term use of triclosan dentifrice does not result in the development of microbial resistance, does not cause a shift in the normal oral microbial ecosystem, and does not cause any other adverse microbial changes, as evidenced by data collected from clinical trials of at least 6 months duration and longer.11,14
Triclosan can be absorbed through skin and mucosa, and via ingestion, with levels detectable in blood, urine and breast milk that correlate closely with patterns of consumer product use.15 However, pharmacokinetic studies in humans show that following normal use of triclosan-containing dentifrice, triclosan does not accumulate in the blood or body tissues, and no adverse systemic effects have been documented following long-term use of this dentifrice. 16 Even when brushing 3 times per day with full ingestion of the product, triclosan is completely eliminated from the body, mainly through excretion in the urine.16-17
Triclosan is not carcinogenic to humans.3,4,6,15,17 Recent studies performed in animal models suggest that oral administration of triclosan may be linked with altering hormonal regulation, specifically with thyroid function and reproduction. The FDA reviewed this data and determined that due to study design limitations, interspecies differences, and variability in routes of administration and dosing compared to those used in consumer products, the data cannot be readily extrapolated to humans. To date, there is no evidence to show that disruptions in endocrine function occur in humans.3,15,17 One longitudinal randomized placebo-controlled clinical trial monitored thyroid function for 4 years in 132 subjects who brushed twice daily with either 0.3% triclosan dentifrice or placebo. After 4 years, continued use of triclosan dentifrice failed to produce any detectible effects on thyroid function, further lending support for long-term safety with normal use.18 Additional research is warranted.
No adverse hard or soft tissue effects have been documented with chronic use of this dentifrice. Triclosan has not been shown to contribute to mucosal sloughing. Sloughing may be observed in individuals who are sensitive to other ingredients that are commonly found in dentifrice formulations, including sodium lauryl sulfate, flavoring agents, and notably the pyrophosphates found in tartar-control formulations.19-21 Two studies have shown that triclosan reduces the oral mucosal inflammation and sloughing observed following exposure to sodium lauryl sulfate in humans.22,23 It is important to note that Colgate Total® toothpaste does not contain pyrophosphates, and produces its anti-tartar effects by reducing biofilm.
The concentration of triclosan found in Colgate Total® toothpaste is 0.3%, making the impact of use on the environment negligible. Up to 98% of triclosan is removed in wastewater treatment plants following expectoration down the drain, where any remaining triclosan will continue to break down, as it is biodegradable.24 Environmental toxicity studies show that any residual triclosan appearing as biosolids in the land is unlikely to produce any adverse effects in birds, mammals, invertebrates and plants.25 Effects on soil fertility would only occur in "worst case exposures" and would likely be transient and dependent upon certain soil conditions.25/p>
Current research supports that children and adults who use triclosan as intended in their consumer products should not expect to develop adverse reactions.15 Research to date strongly supports the safety of triclosan-containing dentifrice with normal use. Additional information about triclosan in consumer products is available from the FDA.26
U.S. Food and Drug Administration. Available at: http://www.fda.gov/
Heath Canada. www.hc-sc.gc.ca
Scientific Committee on Consumer Safety of the European Commission. http://ec.europa.eu
Australian National Industrial Chemicals Notification and Assessment Scheme. www.nicnas.gov.au
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). http://www.mhra.gov.uk
U.S. Environmental Protection Agency. www.epa.gov
Riley P, Lamont T. Triclosan/copolymer containing toothpastes for oral health. Cochrane Database Syst Rev. 2013 Dec 5;12:CD010514. doi:10.1002/14651858.CD010514.pub2.
Gunsolley JC. A meta-analysis of six-month studies of antiplaque and antigingivitis agents. J Am Dent Assoc. 2006 Dec;137(12):1649-57.
Niederman R. Triclosan-containing toothpastes reduce plaque and gingivitis. Evid Based Dent. 2005;6(2):33.
Hioe KP, van der Weijden GA. The effectiveness of self-performed mechanical plaque control with triclosan containing dentifrices. Int J Dent Hyg. 2005 Nov;3(4):192-204.
Panagakos FS, Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin HM. Advanced oral antibacterial/anti-inflammatory technology: A comprehensive review of the clinical benefits of a triclosan/copolymer/fluoride dentifrice. J Clin Dent. 2005;16 Suppl:S1-19.
Davies RM, Ellwood RP, Davies GM. The effectiveness of a toothpaste containing triclosan and polyvinyl-methyl ether maleic acid copolymer in improving plaque control and gingival health: a systematic review. J Clin Periodontol. 2004 Dec;31(12):1029-33.
American Dental Association. ADA Seal Products Category: Plaque and Gingivitis Control Toothpastes. Available at: http://www.ada.org/5266.aspx?attributes=Plaque%2fGingivitis+Control. Accessed February 20, 2014.
Cullinan MP, Bird PS, Heng NC, West MJ, Seymour GJ. No evidence of triclosan-resistant bacteria following long-term use of triclosan-containing toothpaste. J Periodontal Res. 2013 May 14. doi: 10.1111/jre.12098.
Dann AB, Hontela A. Triclosan: environmental exposure, toxicity and mechanisms of action. J Appl Toxicol. 2011 May;31(4):285-311.
Bagley DM, Lin YJ. Clinical evidence for the lack of triclosan accumulation from daily use in dentifrices. Am J Dent. 2000 Jun;13(3):148-52.
Rodricks JV, Swenberg JA, Borzelleca JF, Maronpot RR, Shipp AM. Triclosan: a critical review of the experimental data and development of margins of safety for consumer products. Crit Rev Toxicol. 2010 May;40(5):422-84.
Cullinan MP, Palmer JE, Carle AD, West MJ, Seymour GJ. Long term use of triclosan toothpaste and thyroid function. Sci Total Environ. 2012 Feb 1;416:75-9. doi: 10.1016/j.scitotenv.2011.11.063.
DeLattre VF. Factors contributing to adverse soft tissue reactions due to the use of tartar control toothpastes: report of a case and literature review. J Periodontol. 1999 Jul;70(7):803-7.
Kowitz G, Jacobson J, Meng Z, Lucatorto F. The effects of tartar-control toothpaste on the oral soft tissues. Oral Surg Oral Med Oral Pathol. 1990 Oct;70(4):529-36.
Neppelberg E, Costea DE, Vintermyr OK, Johannessen AC. Dual effects of sodium lauryl sulphate on human oral epithelial structure. Exp Dermatol. 2007 Jul;16(7):574-9.
Skaare A, Eide G, Herlofson B, Barkvoll P. The effect of toothpaste containing triclosan on oral mucosal desquamation. A model study. J Clin Periodontol. 1996 Dec;23(12):1100-3.
Skaare AB, Rölla G, Barkvoll P. The influence of triclosan, zinc or propylene glycol on oral mucosa exposed to sodium lauryl sulphate. Eur J Oral Sci. 1997 Oct;105(5 Pt 2):527-33.
Bock M, Lyndall J, Barber T, Fuchsman P, Perruchon E, Capdevielle M. Probabilistic application of a fugacity model to predict triclosan fate during wastewater treatment. Integr Environ Assess Manag. 2010 Jul;6(3):393-404.
Fuchsman P, Lyndall J, Bock M, Lauren D, Barber T, Leigh K, Perruchon E, Capdevielle M. Terrestrial ecological risk evaluation for triclosan in land-applied biosolids. Integr Environ Assess Manag. 2010 Jul;6(3):405-18.
U.S. Food and Drug Administration. Triclosan: What Consumers Should Know. Posted April 2010; Updated November 25, 2013. Available at: http://www.fda.gov/forconsumers/consumerupdates/ucm205999.htm. Accessed February 20, 2014.