FDA To Decide Whether Antibacterial Soap Is Safe – After Four Decades

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[Source: FDA}

[Source: FDA}

Antibacterial soap has been around for 40 years. But research now shows that the active ingredient in the soap, triclosan, alters hormonal balance in animals, is possibly harmful to the immune system, and possibly contributes to the rise of antibiotic resistant germs.

I’ll give you a moment to dump all your triclosan-containing antibacterial liquid soaps and body washes that you’ve been using for years into the trash.

Triclosan, which kills both bacteria and fungus, is found in about 75 percent of antibacterial products. In addition to soaps, it’s found in deodorants and toothpaste and mouthwashes where it helps prevent gingivitis, and it’s infused in various household products such as garbage bags, kitchen utensils, furniture, clothing, toys, and some cosmetics.

Need another moment?

In short, triclosan is all around us. Which is why it’s a good thing that the FDA has decided to take a look at the compound to see first of all if it actually works, and secondly if it’s harmful. The move has been prompted by recent animal studies showing triclosan affects hormone regulation in animals. If the same holds for humans, it could increase risk of hormone-related problems such as infertility and early puberty.

“To me it looks like the risks outweigh any benefit associated with these products right now,” Allison Aiello, professor at the University of Michigan’s School of Public Health told the associated press. “At this point, it’s just looking like a superfluous chemical.”

And a possibly dangerous one.

But how could a chemical that has been in everyday household products since 1972 only now face scrutiny by the FDA? The truth is, many chemicals used in household products have never received an FDA stamp of approval because they were developed decades ago before laws required a scientific review of cleaning ingredients.

Triclosan, the antibacterial and antifungal agent in liquid soap and a great many other things may disrupt hormone regulation and contribute to antibiotics resistance in germs. [Source: Wikipedia]

Triclosan, the antibacterial and antifungal agent in liquid soap and a great many other things may disrupt hormone regulation and contribute to antibiotics resistance in germs. [Source: Wikipedia]

In 1972 Congress passed a law requiring the FDA to set guidelines for many over-the-counter antibacterial chemicals that manufacturers were to follow. In 1978 the guidelines reflected the FDA’s stance on triclosan as “not generally recognized as safe and effective” because the research scrutinizing its safety and effectiveness was inconclusive. The guidelines, however, were never finalized so companies continued to make products with triclosan.

The antibacterial did score a victory in 1997 with its approval for use in Colgate’s Total toothpaste after the Colgate-Palmolive Co. demonstrated it helped prevent gingivitis. For the rest of the products, however, the FDA had set a 2012 deadline for itself to complete its review.

At about the time that deadline had come and gone, animal studies emerged showing triclosan to alter hormone regulation and other studies with bacteria indicated that triclosan may increase antibiotics resistance. The hormone study corroborated the results of a 2009 study performed by the Environmental Protection Agency that showed the compound decreased testosterone levels and sperm production in rats and a 2010 study by the University of Florida showing that it interfered with movement of estrogen into fetuses in pregnant sheep. In response to public concern, the FDA issued a consumer update saying they’d finish the review by the end of the year.

They didn’t, but they’re still at it: “We are engaged in a comprehensive scientific and regulatory review of all the available safety and effectiveness data. This includes data relevant to the emerging safety issues of bacterial resistance and endocrine disruption due to triclosan in FDA-regulated products.”

Some aren’t waiting for the results. The data has prompted some hospitals and companies to stop using products with triclosan. In 2010, Kaiser Permanente replaced triclosan-containing soaps from 37 of its hospitals and replaced them with alcohol-based hand sanitizers. And beginning in 2015, Johnson & Johnson is planning to make all of its adult product triclosan-free.

The slow moving FDA certainly isn’t garnering confidence with their unexplained delays. Probably to head off further criticism they haven’t issued another timeframe for the review. When they finally do announce their decision, whatever it is will likely raise the ire of the companies that have to retool entire production lines or consumers won’t believe triclosan is safe no matter what the FDA says. It might get ugly, ugly enough to have to wash people’s mouths out with soap.

Peter Murray

Peter Murray was born in Boston in 1973. He earned a PhD in neuroscience at the University of Maryland, Baltimore studying gene expression in the neocortex. Following his dissertation work he spent three years as a post-doctoral fellow at the same university studying brain mechanisms of pain and motor control. He completed a collection of short stories in 2010 and has been writing for Singularity Hub since March 2011.

Discussion — 7 Responses

  • hank May 20, 2013 on 2:17 pm

    If you read nothing else, read this:


    Good abstract for those who can’t see the full article. It sums up what the pharmaceutical industry can’t afford to acknowledge without losing its whole fantasy approach to business — because it causes more problems.

    “… a critical reality: antibiotic resistance already exists, widely disseminated in nature, to drugs we have not yet invented.
    Thus, from the microbial perspective, all antibiotic targets are “old” targets.”

    • Gino Schafer hank May 22, 2013 on 9:12 am

      So your criticism of the pharma industry is based on what exactly? That resistant microbes already exist?

      And are you (stupidly) saying that we should STOP development of treatments that have saved millions and millions of lives? Because eventually they may not be as effective?

      Your world view has been corrupted and perverted by exposure to liberal politics for far too long. Go out and get some fresh air.

  • transistoride May 22, 2013 on 7:37 am

    But it’s the only thing that stops the hair follicles on my legs from inflaming! 🙁

  • Gaurab Banerji May 27, 2013 on 3:13 am

    too much of sanitation are reducing the immunity of humans. it is advasable that children be exposed to nature so that they develop the natural antibodies