The FDA announced this week that it is proposing a new rule that says antibacterial hand soap and body wash manufacturers must actually demonstrate that the products they are selling us are better at killing germs and maintaining hygiene than regular plain soap and water.
If companies are unable to do this, the FDA’s new rule would require the products to be re-branded to reflect that fact, or reformulated to correct this issue. Otherwise, the soaps in question would have to be withdrawn from the market.
What the rule does not do is cover the kinds of antibacterial products used in health care settings. Nor does it focus on hand sanitizers, which the FDA has said it will consider separately.
The FDA is issuing this new rule because there has been a problem with anti-bacterial soaps and it’s been going on for a while now: despite manufacturer’s claims, there’s actually no concrete proof the products are any better at fighting the bacteria that can cause illness. What’s more, there is cause to think that they could actually damage our health.
The FDA highlights that a number of active ingredients in antibacterial products like triclosan in liquid soaps and triclocarban in bar soaps could lead to what’s known as bacterial resistance. We’re all aware of the fear that because of overuse, viruses are adapting and becoming antibiotic-resistant. The same fear applies here: that the antibacterial soaps millions of Americans are using everyday could increase bacterial resistance and lead to greater health concerns in the future. For that reason, the FDA wants to be sure that we are seeing a benefit from these products and not just using them because we’ve been told they work without proof.
There’s another cause for concern, too. There is some scientific evidence based on animal studies to suggest that chemicals like triclosan and triclocarban disrupt the reproductive system and the metabolism. While the same isn’t necessarily true of human use, there is cause for concern as the amount of products being used in America today means exposure to these chemicals is high.
There have also been a handful of studies into the impact triclosan can have on humans, with one study notably showing that based on laboratory tests on muscle cells, triclosan appears to weaken human muscle tissue.
The use of antibacterial soaps has boomed since the 1970s when the product, once a mainstay of the healthcare profession, caught the market’s eye as a way to protect the family from various diseases and, for instance, the risk of contaminating foods. The chemicals aren’t just found in anti-bacterial soaps though, and can be found in a number of detergents, mouthwash and even baby pacifiers. The proposed rule does not impact the marketing of these items.
The FDA had previously rated the active ingredients in anti-bacterial soap as “generally recognized as safe and effective,” but this was largely based on old data and determinations made back when the products first hit the market. For a number of years now, consumer groups have been concerned about the FDA’s inaction on this subject, and this recent rule change seems to have been precipitated, at least in part, thanks to a recently settled lawsuit.
According to The New York Times, the Natural Resources Defense Council, which among other things fights for greater awareness and regulation of toxic chemicals in products we use everyday, filed a lawsuit in 2010 to try to get the FDA to issue a final rule on how it would regulate antibacterial soaps. The FDA signed a settlement last month and has committed to taking action by 2016.
For its part, the antibacterial soap industry has reacted with a somewhat lukewarm response. The American Cleaning Institute and Personal Care Products Council has issued a statement saying in part:
“Over the past two decades, manufacturers of these products have provided significant data and information to the Agency about the safety and efficacy of this product category.
“We are perplexed that the Agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products. In fact, in 2008, at industry’s request, FDA held a public meeting to discuss the data and industry asked FDA if the Agency required any further information. Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap.”
Yet, the data isn’t quite as conclusive as the antibacterial soap industry seems to think it is, with a number of studies having found little benefit. That said, the industry appears to be quite confident in its assertions and have collectively welcomed the chance to demonstrate the products’ safety and usefulness.
To be clear, and to contradict some of the errant headlines we’ve been reading, the FDA has not said that antibacterial products are unsafe or that they are entirely ineffective — the FDA has pointed out that there is a lack of evidence to back up the industry’s claims. It’s new proposed rule is an attempt to ensure that consumers are not being duped by false claims and its investigation aims to ensure that the products really do carry health benefits without significant risks.
What to Do While the FDA Carries Out its Review and Possible Rule Change?
Concerned consumers are encouraged to wash their hands with regular soap, water (there may be no real need for hot water), and plenty of friction. For those wanting to focus on using simple products to clean with, Care2 has a guide to soaps and soap alternatives here.
Photo credit: Thinkstock.
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