By U.S. Food and Drug Administration (FDA)
January 11, 2022
What Is Triclosan?
Triclosan is an ingredient added to many consumer products intended to reduce or prevent bacterial contamination. It is added to some antibacterial soaps and body washes, toothpastes, and some cosmetics—products regulated by the U.S. Food and Drug Administration (FDA). It also can be found in clothing, kitchenware, furniture, and toys—products not regulated by the FDA.
How Safe Is Triclosan?
Some short-term animal studies have shown that exposure to high doses of triclosan is associated with a decrease in the levels of some thyroid hormones. But we don’t know the significance of those findings to human health. Other studies have raised the possibility that exposure to triclosan contributes to making bacteria resistant to antibiotics. At this time, we don’t have enough information available to assess the level of risk that triclosan poses for the development of antibiotic resistance.
There are other ongoing studies that involve the safety of triclosan. One is a study investigating the potential of developing skin cancer after a long-term exposure to triclosan in animals. Another is a study on the potential breakdown of triclosan to other chemicals on human skin after exposure to triclosan to ultraviolet (UV) rays. At this time, neither study has been completed.
Are There Benefits of Triclosan?
For some consumer products, there is evidence that triclosan provides a benefit. In 1997, FDA reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste. The evidence showed that triclosan in that product was effective in preventing gingivitis.
For other products, such as over-the-counter (OTC) consumer antiseptic products, FDA has not received evidence that triclosan provides a benefit to human health. At this time, FDA doesn’t have evidence that triclosan in OTC consumer antibacterial soaps and body washes provides any benefit over washing with regular soap and water.
In December 2017, the FDA issued a final rule regarding certain OTC health-care antiseptic products. As a result, companies will not be able to use triclosan or 23 other active ingredients in these products without premarket review due to insufficient data regarding their safety and effectiveness. The FDA recently issued a final rule on OTC hand sanitizers and will continue to review the three active ingredients commonly used in hand sanitizers.
How Can I Tell if There Is Triclosan in a Product?
Antibacterial soaps and body washes, and fluoride toothpastes are considered OTC drugs. If an OTC drug contains triclosan, it should be listed as an ingredient on the label, in the Drug Facts box. If a cosmetic contains triclosan, it should be included in the ingredient list on the product label.
What Is FDA Doing to Evaluate the Safety of Triclosan?
FDA has been reviewing safety and effectiveness data on triclosan in the agency’s OTC antiseptic rulemakings. FDA will also continue to monitor and follow the scientific literature available for the safety and effectiveness of triclosan.
For more information on consumer antiseptic washes, see the final rule.