The Food and Drug Administration has not been able to prove whether antibacterial soaps actually prevent illness and is now ordering all antibacterial soap makers to prove the effectiveness of their products within a year, or else they will need to change labeling or stop production.
Besides what one might think, there is currently no evidence that prove the effectiveness of over-the-counter (OTC) antibacterial soap at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.
As a result, the FDA has put out a preliminary rule today that would require antibacterial soap makers to prove that their soaps do provide a clinical benefit - and one that outweighs the possible risks of regular contact with antibiotics.
"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk," Janet Woodcock, who directs the FDA Center for Drug Evaluation and Research, says in a statement.
One ingredient, triclosan, is causing concerns as it has already been known to cause hormone disrupting effects in animal studies. Effects in rats range from shifts in thyroid hormone and testosterone concentrations in males to changes in uterine weight in females.
"In the U.S. consumer setting, where the target population is composed of generally healthy individuals, the risk of infection and the scope of the spread of infection is relatively low compared to the health care setting, where patients are generally more susceptible to infection and the potential for spread of infection is high," the agency writes in its preliminary regulation.
