The FDA Declares Antibacterial Soaps Ineffective

The FDA is calling for the removal of general purpose antibacterial soaps from American stores due to one major concern: they don’t work.

In a release posted Friday, September 2, the FDA formalized a proposed rule it established back in 2013. The agency flagged concerns about certain health risks posed by general sale antibacterial products — those we buy over the counter, as opposed to those used in hospitals — and a lack of data supporting their supposed benefits.

The release stated:

This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use.  This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.

The active ingredients mentioned above, triclosan and triclocarban, have come under increasing scrutiny in the past few years. Studies have suggested that these chemicals do not provide a meaningful antibacterial effect or safeguard us from harmful bacteria with any greater power than conventional soaps. They may even increase bacterial resistance.

Furthermore, scientific studies have highlighted possible links between these active ingredients and environmental damage, as well as serious health implications — including encouraging cancer cell proliferation in some tests.

While these risks must be viewed in the context of the studies in which they were identified, concerns were high enough to prompt an FDA review.

In that review, the FDA called on manufacturers to substantiate the health-guarding claims and safety of their products so the agency could weigh the stated benefits against the possible risks. Manufacturers of the antibacterial products have been unable to satisfy that request.

As a result, the FDA is now requiring companies to cease marketing antibacterial washes that contain the 19 restricted ingredients. The agency notes that some manufacturers have already begun removing their products. Nevertheless, this is a significant change for the industry.

The FDA estimates that, for example, triclosan is currently used in about 97 percent of antibacterial and antimicrobial products — to the estimated tune of 2,000 commonly stocked antibacterial items. Therefore, this rule sends a clear message to manufacturers: if you make a health claim, you better be able to back it up.

The release also notes that three additional active ingredients are under scrutiny: benzalkonium chloride, benzethonium chloride and chloroxylenol, or PCMX. The FDA has deferred making a decision on these ingredients for one full year as it waits for the “development and submission of new safety and effectiveness data for these ingredients.”

In the meantime, the FDA’s director at the Center for Drug Evaluation and Research is drawing attention to the misleading information put out by manufacturers of some of these products.

“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,” Dr. Janet Woodcock explained. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

Manufacturers will now have one year to comply with this new rule and pull their products from stores or reformulate to remove the identified ingredients. For health advocates who have long fought against antibacterial soaps, this is a small victory, but the fight will go on.

In the meantime, the FDA is highlighting how proper hand washing with soap remains one of the easiest and most effective methods of guarding ourselves from harmful bacteria.

Photo credit: Thinkstock.

88 comments

Sarah Hill
Sarah Hill2 years ago

Regular soap clean just as well & kills just as many germs as the antibacterial kinds.

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Michelle Spradley

"Antibacterial soap" is a redundant statement. We are "antibacterializing" ourselves to death, making ourselves less able to handle minor infections and illnesses.

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Marie W.
Marie W2 years ago

Finally

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Heidi W.
Heidi W2 years ago

Before using anti-bacterial soap on a daily basis, ask yourself: would you use penicillin the same way? Answer: NO, because it destroys your immune system if taken unnecessary and it creates superbugs. Same goes for these stupid soaps and detergents.

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Siyus Copetallus
Siyus Copetallus2 years ago

Thank you for sharing.

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Mark Donner
Mark Donner2 years ago

Never trust the thousands of medical quacks, and FDA crooks who prescribe pharm poisons in buckets and conveniently know nothing about nutrition, vitamins, minerals or natural cures.

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Mark Donner
Mark Donner2 years ago

The FDA may be right one out of a million times by random accident, but in the vast majority of cases the rule of thumb is "if the FDA is against it, use it, it will cure you." Right now I'm using a cheap concoction which literally cures periodontal disease (an a host of other disease including various cancers) , which is of course banned by the FDA since it would eat into the profits of the criminal pharm mafia.

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Nena C.
Nena C2 years ago

agree, good ole soap and water can not be beat!

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Quanta Kiran
Quanta Kiran2 years ago

finally

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Jeanne Rogers
Jeanne R2 years ago

Thank you for sharing.

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