On December 17, 2013, the FDA issued a Proposed Rule for consumer antiseptic wash drug products. Prior to this Proposed Rule, the last Tentative Final Monograph ("TFM") issued for antiseptic active ingredients was in 1994 (59 Fed. Reg. 31,402), which classified 22 active ingredients for over-the-counter ("OTC") antiseptic handwash use.
The new Proposed Rule affects manufacturers of antibacterial hand soap and hand and body wash products containing OTC antiseptic active ingredients for repeated daily use, to be used with water. Those products do not include hand sanitizers or wipes. Additionally, the Proposed Rule is only to evaluate consumer antibacterial products and not health care setting antibacterial products, which have distinct proposed use settings, target populations, and risks for infection.
The Proposed Rule requires manufacturers of antibacterial soaps and washes to: (1) demonstrate the products are safe for long-term daily use; and (2) demonstrate with clinical data that the products are more effective than plain soap and water in the prevention of illness and the spread of infection. The manufacturers have one year to submit new data demonstrating that safety and effectiveness. If a manufacturer cannot demonstrate those two requirements, then it will have to reformulate the product (remove the antibacterial active ingredient).
The data a manufacturer will be required to submit to demonstrate safety and effectiveness is: (1) safety data studies as described in current FDA guidance; (2) data to characterize potential hormonal effects; and (3) data to evaluate the development of bacterial resistance. That additional safety data, as well as effectiveness data, is needed for antibacterial active ingredients to be generally recognized as safe ("GRAS") and generally recognized as effective ("GRAE"). There is currently no evidence that antibacterial soaps and washes are more effective at preventing illness than plain soap and water (i.e., have the benefit of reducing the number of infections in the population using the products). Therefore, FDA proposes "that data from clinical outcome studies (demonstrating a reduction in infections) are necessary to support a GRAE determination for consumer antiseptic wash active ingredients."
You may be asking yourself, why is FDA concerned now, after almost twenty years? The answer is that there is new information suggesting that long-term exposure to antibacterial active ingredients, like triclosan or triclocarban, could cause bacterial resistance or hormonal effects, or pose other health risks. For example, laboratory studies have shown that triclosan may contribute to bacteria becoming resistant to antibiotics, since bacteria use some of the same resistance mechanisms against antiseptics as they do against antibiotics. So the use of antiseptics with triclosan could result in selection of bacteria resistant to antibiotics. Also, some animal studies show that triclosan may alter hormones, so further evaluation is needed to understand how triclosan might affect humans and specifically children, as those hormonal alterations may have developmental or reproductive effects. Additionally, the current data is not sufficient to show there is any additional benefit from consumer antiseptic hand wash versus plain soap and water. And FDA says, "[W]hen judged against the criteria in the 1994 TFM, the studies are not adequately controlled to allow an accurate assessment of the effectiveness of consumer antiseptic wash active ingredients for one or more reasons." Plus, since the last data was submitted to FDA, there have been important developments in how the evaluation of safety is performed.
FDA has opened up a public comment period until June 16, 2014, and then a 60-day rebuttal comment period will follow.