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New Study Raises More Questions About Triclosan Health Effects

August 20, 2012

On August 14, 2012, researchers from the University of California, Davis, and the University of Colorado published findings suggesting that the antibacterial ingredient triclosan causes muscle weakness. The researchers observed that after exposure to triclosan, heart muscles in mice showed a diminished ability to contract, and that fish exposed to the ingredient showed reduced swimming activity.

These findings come more than two years after the chairman of the House Energy and Commerce Subcommittee on Energy and Environment called for a ban on many applications of triclosan, and the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) released correspondence revealing concerns about the possible health effects of triclosan. [See previous client alert: Triclosan and Increased Scrutiny of Chemicals] Despite its own stated concerns, FDA has maintained that triclosan is not known to be hazardous to humans. However, companies should not draw too much comfort from these assurances, as the agency has indicated that its opinion does not reflect a thorough review of the most recent studies. 

Although not approved by the FDA, triclosan is used as an antibacterial agent in a number of household cleaning and personal hygiene products sold in the United States, including soaps, deodorants, hand-sanitizers, toothpastes, and mouth wash. In recent years, manufacturers have also expanded the use of triclosan as an antimicrobial in cosmetics, socks, workout clothes, and toys.

Triclosan has been previously scrutinized for its disruptive effects on the body's endocrine system and whether its use promotes the creation of bacteria that are resistant to antibiotics. Triclosan is under consideration by FDA for inclusion in the monograph for over-the-counter topical antimicrobial products, and thus products that contain it are not usually targeted for agency enforcement actions.  FDA, however, has said that to date, it "has not received evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water." Absent new data showing a positive effect, it is unlikely that FDA will include triclosan in the monograph if and when it issues a final rule.

Some companies have already responded to increased public concerns about triclosan by taking steps to remove it from their product lines. Last year, for example, a major manufacturer of oral care, personal care, and home care products announced it was removing triclosan from most of its home-care products, and more recently a multi-national manufacturer of personal hygiene and other products followed suit announcing that it is phasing triclosan out of its beauty and baby care products.

From a product liability standpoint, these new studies may give rise to toxic tort lawsuits from customers claiming health impacts from triclosan. Although most triclosan studies support a history of safe use, these new animal studies may be used as support for alleged human health complaints. Companies that have incorporated triclosan into their products should develop risk mitigation strategies to prepare for the inevitable class action lawsuits aimed at deep corporate pockets. At a minimum, manufacturers and users of triclosan products should closely monitor new research, FDA and EPA comments, and developing governmental actions impacting the continued use of triclosan.   

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910