FDA toughens stand on antibacterial soap labelling

Over-the-counter antibacterialhand and body wash products containing certain active ingredients can no longer be marketed, the U.S. Food and Drug Administration announced Friday.

The FDAissued what is calledits final rule on safety and effectiveness of the soaps, saying it appliesto products containing one or more of 19 specific active ingredients, including the most commonly used ingredients triclosan and triclocarban.

The two chemicals are similar in structure and function. The FDA says someshort-term animal studies have shown that exposure to high doses of triclosan is associated with a decrease in the levels of some thyroid hormones.

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It says other studies haveraised the possibility that exposure to triclosan contributes to making bacteria resistant to antibiotics.

"Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections," the FDA said in a statement.

Long-term harm possible

"Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long term."

Some manufacturers have already started removing these ingredients from their products, the agency said.

When the FDA set out tofinalize the rule in December 2013, it said antibacterial soap products would not have to be removedfrom the market. It said if companies could not provide data to support an antibacterial claim, then they would have to change the product's formula,removing theactive antibacterial ingredients,or at leastremove the antibacterial claim from the product's labelling.

The rule does not affect hand sanitizers or wipes.

In 2012, a Canadian government study found thattriclosan in waste water can interfere with the growth and reproduction of plants and animals in lakes and streams.

The finding led to Health Canada and Environment Canada to propose that industry voluntarily cut the amount of triclosan it uses, particularly in personal-care products that tend to get rinsed away into lakes and rivers.

A spokesman for Health Canada said the final results of a governmentassessment oftriclosan will be published "in the near future."

"The government will continue to monitor new scientific evidence related to triclosan and will take further action if warranted,"Andr Gagnon said.