FDA Deems Certain Ingredients Ineffective In Antibacterial Soaps

Today the Food and Drug Administration issued a final rule banning the marketing of over-the-counter (OTC) consumer antiseptic soaps or washes containing certain ingredients.  This follows a three year process where the agency assessed claims as to the safety of these ingredients and their effectiveness compared to regular soap and water.  Some ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) have been deferred from final consideration until a later date.

The products subject to this rule are intended for use with water and to be rinsed off.  This means that antiseptic wipes or hand sanitizers are not covered by the rule.  So you don’t have to toss your Purell just yet, but I still think you’re better off with soap and water (as does the Centers for Disease Control and Prevention).  The FDA is continuing to assess the effectiveness and safety of those wipes and sanitizers for consumers, as well as antiseptics for health care use.

These are the 19 ingredients that can no longer be part of OTC antiseptic soaps or washes marketed to consumers in the United States

  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodophors (Iodine-containing ingredients)
    • 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)
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye

Of these 19, triclocarban and triclosan are the most commonly used.  However, some manufacturers have been phasing out these ingredients over the last few years, so it may already be difficult to find products with at least those two ingredients.

The rule will take effect on September 6, 2017.


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