Why Has the FDA banned Antibacterial Soap?

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The U.S. Food and Drug Administration (FDA) has announced that hand and body washes containing certain antibacterial ingredients can no longer be widely sold (the final rule can be found here, and the consumer update is here). Why have they been banned?

Why Has the FDA banned Antibacterial Soap?

The Banned Antibacterial Ingredients

In high enough concentrations, antibacterial ingredients kill bacteria either by rupturing their membranes (their “skin”) or by interfering with how they work.

19 of these ingredients have been targeted:

  • 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

The most common ones in hand soap are triclosan and triclocarban. Any hand or body washes containing these ingredients will not be able to be sold in the US from September 2017.

Three other antibacterial ingredients are still being reviewed, but can still be used in soaps for the time being: benzalkonium chloride, benzethonium chloride, and chloroxylenol.

Why have antibacterial soaps been banned?

The key reason is: because they don’t work any better than non-antibacterial soaps to warrant the potential risks. While antibacterial soaps do tend to kill more bacteria, this hasn’t translated into tangible health benefits, like reduced rates of sickness. In the FDA’s regulatory terms, they’re no longer “generally recognised as safe AND effective (GRAS/GRAE)”.

The risks are:

Possible health effects from long-term, frequent exposure

Animal studies suggest that some antibacterial ingredients may contribute to health problems like hormonal disruption and skin cancer. A positive result in an animal study doesn’t automatically translate to humans, since there are fundamental differences between species – for example, chocolate is poisonous to dogs, and two paracetamol (acetaminophen) tablets will kill a cat. But it does signal that there could potentially be a problem, and more research is warranted (and is currently underway).

Contributing to antibiotic resistance

Antibiotics are a mainstay of modern medicine. However, a few bacteria have a natural immunity to antibiotics, and will survive and multiply. If this happens on a large enough scale, the bacteria will become resistant to that antibiotic, and you’ll need a new antibiotic. The scary thing is that antibiotic resistance is developing at a frightening speed – faster than the discovery and development of new antibiotics. Which means in the not-too-distant future, we may regress back to a scary time when skin infections were ~11% lethal.

Antiseptics aren’t antibiotics, but some studies have suggested that resistance to antiseptics is building in the same way, and that antiseptic-resistant bacteria are also antibiotic-resistant. This means that the widespread use of antiseptics could be contributing to the growth of superbugs that are resistant to common antibiotics.

Why Has the FDA banned Antibacterial Soap?

Should I stop using all antibacterial products then?

Not necessarily. Note that the FDA has only banned them in hand soaps because the risks outweighed the benefits…and in hand soaps, the benefits are zero, because at the moment, the evidence shows that plain soap works just as well. Which means any risk is too much risk.

However, this decision was based on lack of evidence for effectiveness, and some evidence of potential harms. So if further evidence (clinical studies, for example) show that antibacterial soaps are effective, or that the health risks aren’t relevant for humans, the ban might be reversed. Unfortunately, science is often messy and inconclusive like that!

Note that these ingredients haven’t been banned in other consumer products that contain antibacterial ingredients like wipes, hand sanitisers, toothpastes or first-aid disinfectants, and they’re still allowed in healthcare settings (hospitals etc.). That’s because these situations are different, in terms of how the products are used and what the risks are – in wipes and sanitisers, the antibacterial ingredients stay on your skin for longer and would likely have a greater chance of killing the bacteria, while in healthcare settings, the bacteria present are often more harmful, and in some situations (e.g. open wounds, severely immunocompromised patients) small amounts of bacteria can be very dangerous. In these cases, the risks of antibacterial use are likely to be small compared to the benefits.

My personal approach is to avoid using antibacterial products unless necessary, such as if I have a cut that’s showing signs of infection; if I don’t have access to soap and water before eating, I’ll use an antibacterial hand rub containing alcohol as the active ingredient, since it’s impossible for bacteria to become resistant to alcohol, and its health effects are known and minimal. With emerging research on the microbiome indicating the importance of beneficial bacteria in our health, I’m becoming more wary of the “kill all the germs!” approach to staying well.

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15 thoughts on “Why Has the FDA banned Antibacterial Soap?”

  1. Thank you for writing about this! I always knew the All Things Anti-Bac craze was a little overboard, but I didn’t know that the FDA had actually banned the handsoaps. Also, I am so excited to find your blog! I love beauty and skincare, and I always wished I understood more about the science behind it. When I read the tagline in your header I said, “Oh my God yay!” out loud. 😀

    Reply
  2. Hi,

    Interesting post!

    So does this also mean ‘acne’ facial cleansers with triclosan will be banned in de US?

    I’m curious what the European Commission will say about this (I’m from the Netherlands).

    Reply
    • That’s a good question! I’m guessing not, since they’re meant to treat a disease, versus prevention transmission of germs.

      I think Europe already has limited approvals for triclosan, though I’m not sure about the other ingredients.

      Reply
  3. Hi Michelle, thank you for yet another brilliant, clear, well-researched post. Love your blog – you always manage to convey the science of skincare in an enjoyable & easily understood way. Basically, you rock! 🙂

    Reply
  4. Thank you for this article, I was really not aware of the ban… I live in Canada so maybe that will have repercussions on our country, I don’t really know..
    I love putting Purel to disinfect my hands and only (naively) buy soap written “antibacterial” on ? I didn’t know about the potential consequences of long-term use of antibacterial ingredients and the danger of bacterias.. I will be more careful now..
    Thank you again.

    Reply
    • I think in general what the US does has large impacts on everywhere else, since most brands stock the same or very similar products worldwide (plus this decision’s pretty solidly based)… I wouldn’t be surprised to see the same move in Australia soon!

      Reply
  5. Very interesting! I am curious about how this will affect the tattoo industry. Part of the after-care for a tattoo is to clean with antibacterial soap. I’m sure for hand washing, there’s no difference between regular and antibacterial, but for tattoo care, that is more like caring for a wound. You mentioned that medical setting should still be able to get antibacterial soap. I wonder how regular people will be able to properly clean their tattoos!

    Reply
  6. Such a great post, thank you for sharing! I’m so cautious about antibiotics and antibacterials so I’m glad there has been fundamental changes made to reverse the potentially awful results of their overuse.

    Reply
  7. Its all very interesting. I’m off to read the ingredients on our hand washes at home and work (I’m a registered nurse/midwife)! Thanks for the info xx

    Reply
  8. Wow thank you for sharing this, it was such an interesting post! I had been using anti bacterial products, just thinking that they were the better choice but admittedly blindly thinking that and never thinking about the effects of it. So glad to have read this and gained some useful insight!

    Reply
  9. I LOVE your blogs and research and read your stuff quite frequently. I’m a licensed esthetician and am curious Where you find your research and if you’re subscribed to something that gives you updates on skincare news and/or products? As you know, skincare is forever evolving and sometimes its hard to keep up with, So i’m just curious on how you keep up with it all. 🙂

    Reply
  10. Antibacterial or not, I like liquid soap with a pump mechanism where I can control the quantity effectively over a ‘bar’ of soap. Perhaps there’s a gap in the market again to reintroduce ‘normal’ liquid soaps.

    Reply

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