Ban On Non-Medical Uses Of Triclosan Products Sought In Citizen Petition

Bacterial resistance that may result from use of triclosan should cause FDA to "immediately ban all non-medical uses" of the antibacterial agent, a coalition of public interest groups maintains in a citizen petition filed with the agency.

"A large number of recent studies have found substantial evidence that triclosan and triclosan-containing products promote the emergence of bacteria resistant to antibiotic medications and antibacterial cleansers," the petition, filed Oct. 25, states.

"Resistance effects have been shown at low, bacteriostatic and sub-biocidal levels, such as residues that remain hours after tooth-brushing or hand-washing."

Sixteen public health and environmental groups led by Beyond Pesticides are behind the effort. The Campaign for Safe Cosmetics, Breast Cancer Action, Breast Cancer Fund and the Alaska Community Action on Toxics are among the other signatories.

During an Oct. 20 meeting, FDA's Nonprescription Drugs Advisory Committee concluded that marketers of non-alcohol-based antiseptics should be required to provide data on their product's effectiveness prior to marketing it.

The recommendation was made in part because of the potential risks involving bacterial resistance (¹ , p. 5).

"Data show that bacteria will become resistant to antibacterial products like triclosan, rendering the products useless to those who actually need them for medical purposes, such as people with compromised immune systems," the petition notes.

"With so many products on the market containing triclosan, scientists predict that the speed with which resistance develops is likely to be increased."

Concerns about the potential link between triclosan and antimicrobial resistance have been voiced by others in the medical community. In 2000, a report by the American Medical Association advised that in light of resistance concerns, it would be "prudent" to avoid use of antimicrobial agents in consumer products (² (Also see "Antimicrobial Consumer Product Resistance Concerns Voiced By AMA" - Pink Sheet, 19 Jun, 2000.), p. 3).

In addition to concerns about resistance, the groups maintain that triclosan is unsafe because it produces a carcinogen when in contact with water.

The petitioners cite a study that imitated dishwashing conditions and found that triclosan reacts with the free chlorine in tap water to produce "significant quantities" of chloroform gas. The study, by K.L. Rule, et al., was published online in April 2005 by the journal Environmental Science & Technology.

"This raises serious concerns about other types of triclosan-containing products, such as toothpastes and hand soaps, which can be expected to similarly produce chloroform when they come in contact with tap water," the petition states.

Reports that triclosan exposure results in skin irritations also are cited in the document, as well as findings that the ingredient has been detected in human breast milk and in the umbilical cord blood of infants.

The groups also point to NDAC's 11-1 vote during the Oct. 20 meeting agreeing that data do not show antibacterial soaps and washes to be more effective than regular soap and water in reducing infections.

The same assertion about regular soap and water has been made by the Centers for Disease Control & Prevention, the letter adds.

Triclosan is "ineffective at preventing disease and unnecessary for everyday use," the petition maintains. "No current data demonstrate any extra health benefits from having antibacterial-containing cleansers in a healthy household."

While triclosan has been proven to be effective in appropriate settings such as in hospitals, it is the "widespread" use of triclosan-containing products in other settings that will decrease the effectiveness of those products, the petition states.

A study by E.L. Larson, et al., published in the Annals of Internal Medicine in 2004 evaluated more than 200 healthy households and found that those using antibacterial products "did not have any reduced risk for symptoms of viral infectious diseases," the groups conclude.

- Bridget Behling