Finally, FDA issues rule on antibacterial soaps

6a00e5500815768834019b032caae3970d.jpgAfter years of requests from consumer and health groups, the U.S. Food and Drug Administration finally issued a rule banning the use of triclosan and 18 commonly used chemicals in over-the-counter antibacterial hand soaps.

Companies won’t be able to market the soaps with these ingredients because manufacturers didn’t demonstrate that the ingredients are safe for long-term daily use and more effective than soap and water in preventing illness and the spread of infections, the FDA said.

Some manufacturers have already started removing the ingredients from their products. They’re still found in some acne products, body washes, and Colgate Total toothpaste.

“This decision by the FDA is a huge victory on behalf of human health and the environment,” said Ken Cook, co-founder and president of the Environmental Working Group. “EWG has been conducting research and advocating for this exact federal government action for nearly a decade, and our work, as well as that of other public interest groups and many of our supporters, has finally paid off.”

Triclosan is a toxic chemical ingredient associated with hormone disruption in people. In 2008, the EWG found triclosan and 15 other toxic chemicals in the blood and urine of 20 teen girls from eight states and the District of Columbia.

Consumer antibacterial soaps with triclosan and triclocarban were put on the market without data demonstrating clinically significant health benefits from their use in a non-hospital setting, the EWG said.

This final rule applies to consumer antiseptic hand soaps containing one or more of 19 ingredients, including the most commonly used ingredients – triclosan and triclocarban. The rule doesn’t affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

The FDA issued a proposed rule in 2013. Manufacturers were required to provide the agency with additional data on the safety and effectiveness of ingredients used in antibacterial hand soaps if they wanted to keep marketing them.

The FDA has deferred rulemaking for one year on three ingredients used in antibacterial hand soap – benzalkonium chloride, benzethonium chloride, and chloroxylenol. They can be marketed while information is being collected.

Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others, the FDA said.

Manufacturers have one year to comply with the rule by removing products from the market or by removing antibacterial ingredients in the products.

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