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FDA Proposes New Rule for Antibacterial Soaps (December 2013)

The Food and Drug Administration (FDA) has released a proposed rule that will require manufacturers to show that antibacterial soaps and body washes – sometimes referred to as antimicrobial or antiseptic soaps/body washes – are safe and more effective than traditional soap and water. Because of the significant number of consumers using antibacterial hand soaps, FDA believes that there must be clearly demonstrated benefits to balance any potential risks. Currently, FDA states that there 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. Furthermore, some data suggest that long-term exposure to certain active ingredients used in antibacterial products could pose health risks, such as hormonal effects and bacterial resistance.

Under the currently released proposed rule, products that do not have supporting data on safety and efficacy one year after the publication of the final rule would have to be reformulated (remove antibacterial active ingredients), relabeled (remove the antibacterial claims) or removed from the market. Any product that is relabeled or repackaged after the effective date would be required to comply with the final rule, regardless of the date the product was initially introduced into commerce. FDA is providing a public comment period of six months (180 days) from the publication of the proposed rule on December 16, 2013. The proposed rule does not apply to hand sanitizers, wipes or antibacterial products used in health care settings.

FDA has proposed the new rule to address the following consumer health concerns:

Systemic Exposure
Since the 1994 proposed rule regulating over-the-counter (OTC) antibacterial drug products, new data have indicated that systemic exposure to topical antibacterial active ingredients may be more than previously thought. Systemic exposure refers to the presence of antibacterial active ingredients inside and throughout the body. For example, testing on the antibacterial active ingredient triclosan has shown that it is absorbed through the skin and has been found in both human breast milk and urine. While some systemic exposure data exist for triclosan, many of the other antibacterial active ingredients have not been evaluated in this regard. There is also a lack of data to evaluate the impact of important use factors that can influence systemic exposure, such as dose, application frequency, application method, duration of exposure, skin condition, product formulation and age.

At present, FDA does not have the necessary data to determine if there is an acceptable margin of safety for the repeated daily use of consumer antibacterial wash active ingredients. Since 1994, FDA has received data suggesting that triclosan and triclocarban can cause alterations in thyroid, reproductive, growth, and developmental systems of neonatal and adolescent animals. Hormonally active compounds have been shown to affect not only the exposed organism but also subsequent generations. Because consumer antibacterial washes are chronic use products that are used by sensitive populations (e.g., children and pregnant women), FDA is requiring an evaluation of the potential for chronic toxicity and effects on reproduction and development in the safety assessment under the proposed rule. The potential for hormonally active antiseptic active ingredients to cause developmental or reproductive effects raises particular concerns for the safe use of the ingredients on children, and FDA may require additional data to support a safe use determination depending on the risks identified in the animal safety assessment.

Antimicrobial Resistance
Since 1994, there is new information available that has raised concerns about the impact of widespread antibacterial use on the development of antimicrobial resistance. Bacteria use some of the same resistance mechanisms against both antibacterial active ingredients and antibiotics. Therefore, the use of antibacterial active ingredients with resistance mechanisms in common with antibiotics may have the potential for bacterial strains to develop resistance to clinically important antibiotics. While laboratory studies have provided evidence of bacterial resistance mechanisms, there is very limited data on the impact of bacterial resistance occurring in a natural setting. Based on increasing evidence regarding the magnitude of the antibiotic resistance problem and the speed at which new antibiotic organisms are emerging, FDA believes it is important to further assess the potential effects of consumer antibacterial use.

In 1997, a joint Nonprescription Drugs (NDAC) and Anti-Infective Drugs Advisory Committee concluded that the data were not sufficient to take any action on the issue of antimicrobial resistance. However, at a 2005 NDAC meeting on antiseptics for consumer use, some NDAC members expressed concern about the societal consequences of the pervasive use of consumer antibacterial wash products, including the potential for antibacterial use to lead to changes in bacterial susceptibilities to clinically important antibiotics. FDA has described the data needed to help establish a better understanding of the interactions between antibacterial active ingredients and bacterial resistance mechanisms in consumer products, and it will provide the information needed to perform an adequate risk assessment for consumer uses. FDA recognizes that the science of evaluating potential compounds to cause bacterial resistance is evolving, and it acknowledges the possibility that alternative data may be identified as an appropriate way for evaluating resistance.

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