The FDA, after years of evading activist and scientific inquiries into the actual benefits and risks of certain chemicals in antibacterial soaps, has finally taken action, demanding data showing efficacy and safety of these ingredients (this has nothing to do with hand sanitizers, by the way). The issues involved here are, however, more complex than it seems at first glance.
As for efficacy, the FDA s request seems clear: if a product is labeled antibacterial, it should be ¦.antibacterial. The agency spokesperson says:
In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.
But wait a minute: there s quite a difference between being antibacterial and actually preventing illness. For a consumer product, even one with FDA-approved over-the-counter (OTC) drugs as ingredients (e.g., triclosan), to prove effectiveness in reducing clinical illness, clinical trials of a double-blind, randomized nature would be required, which raises the stakes considerably. Moreover, the trade industry association, The Personal Care Products Council, had this retort to the FDA s assertion:
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 ¦. 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. Additionally, a review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap.
The other concerns voiced by the FDA are about the potential for these products to promote the growth of resistant germs, and the possible interference with human hormones via the so-called endocrine disruptor mechanism.
ACSH s Dr. Gilbert Ross had this commentary: The FDA is suddenly on the attack on all fronts, after a long hibernation period. This is not necessarily a good thing. How can they suddenly decide that these antibacterial chemicals need to show clinical benefits against...what? Skin infections? Other infections? Ridiculous. If they say antibacterial and folks want to use them, why is it the FDA s business to get in the way IF they are indeed able to kill bugs. If not, the pitch must be removed, I d agree. As for the big NRDC lawsuit that the FDA settled, this sounds an awful lot like the EPA s favorite ploy, where some activist group is encouraged to sue them to make them enforce the regulations and the agency is only too happy to settle. The endocrine disruption concern is a red herring, as the studies done on high-dose rats have nothing to do with humans. That theory is a junk repository, as the FDA well knows.
So the only conceivable realistic concern is the potential for development of resistant organisms. But if the stuff isn t really antibacterial, that should not be an issue either. So what s really going on here? I have no idea, but it seems the FDA is caving in to activist hype. Too bad if true."