Triclosan ingredient in Colgate

What is triclosan?

Triclosan is an ingredient added to many consumer products to reduce or prevent bacterial contamination. It may be found in products such as clothing, kitchenware, furniture, and toys. It also may be added to antibacterial soaps and body washes, toothpastes, and some cosmetics—products regulated by the U.S. Food and Drug Administration (FDA).

What is known about the safety of triclosan?

Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review.

Animal studies have shown that triclosan alters hormone regulation. However, data showing effects in animals don’t always predict effects in humans. Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.

In light of these studies, FDA is engaged in an ongoing scientific and regulatory review of this ingredient. FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.

Does triclosan provide a benefit in consumer products?

For some consumer products, there is clear 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 this product was effective in preventing gingivitis.

For other consumer products, FDA has not received evidence that the triclosan provides an extra benefit to health. At this time, the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water.

What consumers should know:

• Triclosan is not known to be hazardous to humans.
• FDA does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.
• In light of questions raised by recent animal studies of triclosan, FDA is reviewing all of the available evidence on this ingredient’s safety in consumer products. FDA will communicate the findings of its review to the public in winter 2012.
• At this time, FDA does not have evidence that triclosan added to antibacterial soaps and body washes provides extra health benefits over soap and water. Consumers concerned about using hand and body soaps with triclosan should wash with regular soap and water.
• Consumers can check product labels to find out whether products contain triclosan.

How can I tell if there is triclosan in a product that I am using?

Antibacterial soaps and body washes, and toothpastes are considered over-the-counter drugs. If an over-the-counter drug contains triclosan, it will be listed as an ingredient on the label, in the Drug Facts box. If a cosmetic contains triclosan, it will be included in the ingredient list on the product label.

What is FDA doing to evaluate the safety of triclosan?

We are engaged in a comprehensive scientific and regulatory review of all the available safety and effectiveness data. This includes data relevant to the emerging safety issues of bacterial resistance and endocrine disruption due to triclosan in FDA-regulated products.

We also have partnered with other Federal Agencies to study the effects of this substance on animal and environmental health (see http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm; http://www.epa.gov/endo/).

FDA is working to incorporate the most up-to-date data and information into the regulations that govern the use of triclosan in consumer products. FDA anticipates communicating the findings of our review to the public in winter 2012 through our rulemaking process.

FDA has updated its "Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2012," to include "Guidance for Industry: Endocrine Disruption Potential of Drugs: Nonclinical Evaluation."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated Aug. 29, 2012

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