Antibacterial agent needs review, FDA urged

A Democratic congressman is pressing federal regulators to complete their long-delayed safety review of an antibacterial chemical found in thousands of hand sanitizers, soaps and other products.

In a letter sent late Tuesday,Edward Markey ofMassachusettsasked the U.S. Food and Drug Administration for an update on its review of triclosan, an antiseptic chemical used in toothpaste and most antibacterial soaps sold in the U.S.

The FDA announced earlier this year it was looking into animal studies suggesting triclosan can disrupt hormone levels. Other studies suggest the chemical can encourage the growth of "superbugs," or antibiotic-resistant strains of bacteria.

In July, the U.S. Centers for Disease Control and Prevention reported that the average amount of triclosan found in Americans' urine increased 42 per cent between 2003 and 2006, the most recent year for which data is available.

FDA spokeswoman Karen Riley said the agency is working to complete its review, and will likely request additional information about triclosan and related chemicals.

"FDA is planning to issue a proposed rule that will request additional data regarding the safety and effectiveness of topical antimicrobial products for consumer use where the available data are not sufficient," she said.

The FDA previously ruled that there is no evidence soap with triclosan is superior to soap without the ingredient. But the agency also said it "does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time."

The American Cleaning Institute, a soap and detergent trade organization, said the group has provided reams of data to the FDA supporting the use of triclosan-containing cleaners.

"These are products that are used safely and effectively by millions of Americans every day," said Brian Sansoni, a spokesman for the group, whose members include Unilever, Colgate-Palmolive Co. and Dow Chemical Co.

The FDA aims to release its safety assessment next spring though Markey's letter presses FDA commissioner Margaret Hamburg to act sooner.

Phasing out chemical

Health Canada has recommended that people avoid antibacterial products because they kill healthy bacteria that fight harmful germs and because of concerns over the products.

According to the congressman's letter, his office contacted more than a dozen companies that make soaps, cutlery and other consumer goods, asking them to voluntarily remove triclosan from their products. The majority of companies said they would not change their products until the FDA issues its review.

However, several companies are already phasing the chemical out, including Colgate-Palmolive, which plans to reformulate its dishwashing formula. Reckitt Benckiser, maker of Lysol spray along with several soap products, said it plans to reformulate its triclosan-containing products by 2011.

Acme United Corp. and Victorinox both said they have already removed triclosan from their knives as a result of recent regulations passed in Europe.

In March, the European Union banned the chemical from any products that come into contact with food.