FDA toughens stand on antibacterial soap labelling

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

The FDA issued what is called its final rule on safety and effectiveness of the soaps, saying it applies to 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 some short-term animal studies have shown that exposure to high doses of triclosan is associated with a decrease in the levels of some thyroid hormones.

• Antibacterial agent needs review, FDA urged
• Common antibacterial agent called harmful to environment

It says other studies have raised 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 to finalize the rule in December 2013, it said antibacterial soap products would not have to be removed from 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 the active antibacterial ingredients, or at least remove the antibacterial claim from the product's labelling.

The rule does not affect hand sanitizers or wipes.

In 2012, a Canadian government study found that triclosan 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 government assessment of triclosan 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," André Gagnon said.