PhotoIf you’re a fan of antibacterial soaps and other products, you might soon notice some changes to your favorite products. On Dec. 16, the FDA announced in an official release that:

The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings. 

The problem, from the FDA’s perspective, is that many ordinary people might erroneously believe antibacterial soaps don’t merely make things cleaner, but confer actual health benefits compared to “regular” soap — specifically, greater protection against illness.

Not only is there no conclusive evidence to support this, it might actually be the exact opposite: antibacterial products might be harmful. As the press release says, “some data suggest that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects.”

Long-term exposure

The suspicion that antibacterial products might actually be harmful is not new. There is, for example, already a strong correlation suggesting that the recent rise in numbers of children suffering from asthma or allergies might, paradoxically, be due to the rise of children raised in overly clean and sterile environments: if you don’t mind anthropomorphizing the human immune system you could say that it pugnaciously refuses to ever relax and take it easy, so if there are no real germs or bacteria for it to defend against, it will instead pick fights with dust particles, pollen grains, dander or other innocuous-for-most-people things.

Even worse, the excessive use of antibacterial products (especially antibiotics) is directly responsible for the evolution of antibiotic-resistant bacteria.

Indeed, the FDA’s proposed rule change on antibacterial soap comes only a few days after it proposed a voluntary restriction on the use on non-prescription antibiotics fed to livestock. As Dina Fine Maron noted last week in Scientific American:

“Most of the meat on our dinner plates comes from cows and chickens treated with a battery of drugs that helped them grow quickly in dismal, cramped conditions that would otherwise make them sick.  The drugs are blended into their food and water without any requirement for a veterinary prescription…. [the proposed change] calls for pharmaceutical companies to voluntarily alter their drug labels to exclude growth promotion as a listed use, and that would make it illegal to use the drugs for such growth promotion uses in the future.”

 The FDA also proposed new rules requiring livestock producers to get veterinary oversight before using certain antibiotics on their animals – in effect, to make certain antibiotics for animals prescription-only, as they are for humans.

Too little, too late

Yet many scientists fear the FDA’s sudden interest (or, rather, proposed interest) in widespread use of antibaceterial products might be too little, too late. Maron called the FDA livestock proposals "overdue and utterly insufficient," and last October, Dr. Arjun Srinivasan of the Centers for Disease Control warned that, due to the rapid evolution of antibiotic-resistant bacterial strains, humanity is fast approaching the “end of antibiotics.”


The more you use an antibiotic, the more you expose a bacteria to an antibiotic, the greater the likelihood that resistance to that antibiotic is going to develop. So the more antibiotics we put into people, we put into the environment, we put into livestock, the more opportunities we create for these bacteria to become resistant. …We also know that we’ve greatly overused antibiotics and in overusing these antibiotics, we have set ourselves up for the scenario that we find ourselves in now, where we’re running out of antibiotics.

We are quickly running out of therapies to treat some of these infections that previously had been eminently treatable. There are bacteria that we encounter, particularly in health-care settings, that are resistant to nearly all — or, in some cases, all — the antibiotics that we have available to us, and we are thus entering an era that people have talked about for a long time.

For a long time, there have been newspaper stories and covers of magazines that talked about “The end of antibiotics, question mark?” Well, now I would say you can change the title to “The end of antibiotics, period.”

We’re here. We’re in the post-antibiotic era. There are patients for whom we have no therapy, and we are literally in a position of having a patient in a bed who has an infection, something that five years ago even we could have treated, but now we can’t. …

As for antibacterial soap and the proposed new regulations, the FDA stressed that its possible qualms to antibacterial soap does not extend to soap or washing in general: hand-washing remains one of the best ways to limit the spread of germs.

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