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US FDA bans 19 substances from antibacterial soaps

Biocides - Handwash © dalaprod -

The US Food and Drug Administration (FDA) has issued a final rule banning 19 major antibacterial active ingredients from antiseptic wash products. They include triclosan and triclocarban.  

"Manufacturers haven't proven that those ingredients are safe for daily use over a long period of time," the agency says.

And, it adds, they "haven’t shown that these ingredients are any more effective than plain soap and water in preventing illnesses and the spread of certain infections."

Manufacturers will have a year to comply with the rule by removing products from the market, or their antibacterial active ingredients.

The 19 substances covered by the rule are:

  • cloflucarban;
  • fluorosalan;
  • hexachlorophene;  
  • hexylresorcinol;  
  • 6 individual iodophors (iodine-containing ingredients);
  • methylbenzethonium chloride;
  • phenol (greater than 1.5%)
  • phenol (less than 1.5%);
  • secondary amyltricresols;
  • sodium oxychlorosene;
  • tribromsalan;
  • triclocarban;
  • triclosan; and
  • triple dye.

Under the final rule, the FDA has classified the ingredients as not Generally Recognized as Safe and Effective (GRAS/GRAE) for use in consumer antiseptic wash drug products.

Antiseptic products containing these ingredients will be considered new drugs. Approved new drug applications will be required for them.

Covered antiseptic products include liquid, foam and gel hand soaps, bar soaps, and body washes.

The agency issued a proposed rule in 2013 requiring manufacturers to submit data demonstrating the safety and effectiveness of certain antibacterial ingredients used in over-the-counter antibacterial washes.

But, it says, either no additional data was submitted, or the data and information submitted were insufficient for the agency to find that these ingredients are GRAS/GRAE.

The FDA has deferred rulemaking for one year on three other ingredients:

  • benzalkonium chloride;
  • benzethonium chloride; and
  • chloroxylenol (PCMX).

This is to allow for the "development and submission of new safety and effectiveness data for these ingredients."

The final rulemaking does not apply to consumer hand sanitisers, hand wipes, antiseptic products used in healthcare settings, and antiseptics used in food handler settings.

Co-founder and president of the NGO the Environmental Working Group Ken Cook praised the announcement. He says it's  a "huge victory on behalf of human health and the environment".  

But the American Cleaning Institute (ACI) says washing hands with antiseptic soap can help reduce the risk of infection beyond that provided by non-antibacterial soap and water.

"The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps," it says.

"Manufacturers are continuing their work to provide even more science and research to fill data gaps identified by FDA."

The ACI says it will submit, in the coming year, additional safety and effectiveness data on the three deferred ingredients.

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