Cost-Benefit Analysis to Weigh Into Antibacterial Soap Debate

The recent announcement by the Food and Drug Administration (FDA) to investigate the use of “antibacterial” soaps has further fueled the debate over the effectiveness and safety of these washes, as well as the possible detrimental effects of their use. As anyone who has shopped for hand soap in recent years probably has noticed, you are hard-pressed to find more than a couple of options that do not include an “antibacterial” label. While much controversy has existed over the need for these soaps in the past, the attention it is receiving by the FDA may help to resolve the debate.

Background

The use of antibacterial hand soap and washes has become ubiquitous in recent years. According to Colleen Rogers, Ph.D., lead microbiologist with the FDA, this is despite the 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.” Not only is the effectiveness questioned, but the safety of its long-term use are “unproven” due to chemical ingredients such as triclosan and triclocarban, neither of which are generally recognized as safe (GRAS) or generally recognized as effective (GRAE) under FDA standards. Currently, some of the long-term risks of antibacterial use shown from studies on rats shows a decrease in thyroid hormones. Triclosan use may even contribute to “making bacteria resistant to antibiotics,” according to the FDA. While the idea of removing triclosan from some products was first raised in 1978, no action was taken.

FDA Announcement

 Under the new Proposed rule, determinations of under what circumstances such antibacterial soap and wash products are GRAS and GRAE will be made. Now the FDA will require manufacturers to show that not only that their use is more effective than just soap and water, and also that they are safe in the long-term. Effectiveness will be measured by its clinical benefits, meaning the ability to prevent illnesses and the spread of infection.

Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research was quoted in a recent CNN article as saying that, “[the FDA’s] goal is, if a company is making a claim that something is antibacterial and in this case promoting the concept that consumer who use these products can prevent the spread of germs, then there ought to be data behind that.”

The FDA welcomes comments from consumers, clinicians, environmental groups, scientists, and industry representatives, among others, with regard to this topic.

Opinions

In October 22, 2013 interview with “Frontline” report David Hoffman, on National Public Radio’s “Fresh Air,” cited Professor Stuart Levy of Tufts University, a well-known commentator on the topic.  With regard to the use of antibacterials, in hand soap and other types of cleaners, Levy’s opinion is that “this craze that we had for antibacterials in home cleansers was really kind of an error, that we didn’t need them, but by using all this kind of antibacterial stuff – soap suds and so on – and washing it down the drain, we were essentially polluting our environment with the kinds of antibacterials that would create resistance in the environment,” Hoffman noted. He went on to state that “we’re going to wind up with super bugs in our environment.”

Dr. Janet Woodcock, director of the Center of Drug Evaluation and Research with the FDA, was quoted as saying that “[a]ntibacterial soaps and body washes are used widely and frequently by consumers . . . where the risk of infection is relatively low.” She further noted that “there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.” And this is what the FDA hopes to determine through its investigation.