FDA Bans Antibacterial Soaps

Are they safe?

cetaphil-barAs many of my patients know, I am a huge proponent of antibacterial soaps.  Cetaphil Antibacterial Bar is one of my favorites.  I recommend it for acne, rosacea, folliculitis, hand dermatitis and just plain getting us clean.  It is what our family uses in the shower.  I could go on… So, imagine my dismay when I hear that the FDA is banning antibacterial soaps!  What?!  My beloved Cetaphil Antibacterial Bar contains Triclosan, one of the banned ingredients.

You can see the fule FDA ruling here.

The basic summary is that the FDA is concerned that widespread, consistent use of antibacterial soaps will induce bacterial resistance, although there is no solid population based data that shows this to be true.  There is also some concern that when used in extremes, there may be some systemic absorption as some of these ingredients have been detected in urine and in breast milk.

In the end, the ruling states that the 17 chemicals listed cannot be “Generally Regarded as Safe” because there is not sufficient evidence to demonstrate their efficacy and safety in the general population.  PLEASE NOTE, they have NOT been deemed harmful!  Three antibacterial chemicals are still allowed to be used until they are further evaluated for evidence one way or the other.

Interestingly, the rule “covers only OTC consumer antiseptic washes that are intended for use as either a hand wash or a body wash, and does not cover health care antiseptics , consumer antiseptic rubs, antiseptics identified as “first aid antiseptics” , or antiseptics used by the food industry.”

In my opinion, this is further demonstration that they are not really concerned that these chemicals are harmful in any way, they just want to limit the use.  Here’s my problem with it… I touch LOTS of germy things all day, when I get home I want to wash with an antibacterial soap.  Same for my children who attend school and preschool, same for my husband who loves to works outside and may encounter soil based bacteria.  Not to mention the strong prevalence of MRSA in our community, for which I see infected patients on a daily basis.

In my opinion, antibacterial soaps play an important role in containing so many skin based infections.

So, will the new FDA rule change my practice recommendations?  No!  I will continue to recommend and prescribe antibacterial soaps in moderation for as long as they are clinically available.

Companies have one year to remove the below chemicals from their products and begin rebranding and relabeling things previously marketed as antibacterial soaps or washes.

Guess I better start hoarding my Cetaphil Antibacterial Bars before it is too late.

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THE LIST OF CHEMICALS…

Regulatory action is being deferred on three active ingredients that were not included in the proposed rule: Benzalkonium chloride, benzethonium chloride, and chloroxylenol.

This is the list of regulated ingredients.

Cloflucarban · Fluorosalan · Hexachlorophene · Hexylresorcinol · Iodophors (Iodine-containing ingredients) o Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate) o Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol) o Nonylphenoxypoly (ethyleneoxy) ethanoliodine o Poloxamer–iodine complex o Povidone-iodine 5 to 10 percent o 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