Thursday, July 13, 2017

FDA Bans 19 Chemicals Used In Antibacterial Soaps

ALISON KODJAK
September 2, 2016


Consumers don't need to use antibacterial soaps, and some of them may even be dangerous, the Food and Drug Administration says. 

On Friday, the FDA issued a rule banning the use of triclosan, triclocarban and 17 other chemicals in hand and body washes. which are marketed as being more effective than simple soap.

Companies have a year to take these ingredients out of their products or remove the products from the market, the agency said.

"If the product makes antibacterial claims, chances are pretty good that it contains one of these ingredients," Theresa Michele, director of the FDA's Division of Nonprescription Drug Products, said Friday in a conference call with reporters.

The ban applies only to consumer products, not to antibacterial soaps used in hospitals and food service settings.

Many companies have already started phasing out these ingredients, especially after the FDA issued a proposed rule in 2013 that required companies to provide data on products' safety and effectiveness.

But not all. On its website, Dial's "All Day Freshness" antibacterial soap, for one, lists triclocarban as an active ingredient.

The Henkels Co., which owns Dial, didn't respond to an email seeking comment.

Many companies have replaced triclosan with one of three other chemicals — benzalkonium chloride, benzethonium chloride or chloroxylenol (PCMX) — in their antibacterial products. The FDA has given companies another year to provide more data on their safety and effectiveness.

There is some evidence that triclosan, triclocarban and the other chemicals can disrupt hormone cycles and cause muscle weakness, says Mae Wu, a senior attorney at the Natural Resources Defense Council, which originally asked the FDA to ban the ingredients.

The rule is part of a broader effort by the FDA to encourage consumers to skip so-called antibacterial soaps and simply use regular soap and water.

"There's no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water," the agency said in a press release issued shortly after the rule was announced.
But advocates for the soap industry dispute that.
"Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water," said Brian Sansoni, spokesman for the American Cleaning Institute, in an emailed statement.

The FDA statement said that data submitted by the companies about the 19 ingredients wasn't sufficient:

"For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective."

Here is a list of the newly banned chemicals:
  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  • Poloxamer-iodine complex
  • Povidone-iodine 5 to 10 percent
  • Undecoylium chloride iodine complex
  • Methylbenzethonium chloride
  • Phenol (greater than 1.5 percent)
  • Phenol (less than 1.5 percent) 16
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye

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