1 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 2013

Consumer Health Information

www.fda.gov/consumer

Not necessarily, according to 

experts at the Food and Drug Administration (FDA). 

Every day, consumers use antibacterial soaps and body washes at 

home, work, school and in other 

public settings. Especially because 

so many consumers use them, FDA 

believes that there should be clearly 

demonstrated benefits to balance any 

potential risks.

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.

Moreover, antibacterial soap products contain chemical ingredients, 

such as triclosan and triclocarban, 

which may carry unnecessary risks 

given that their benefits are unproven.

“New data suggest that the risks 

associated with long-term, daily use 

of antibacterial soaps may outweigh 

the benefits,” Rogers says. There are 

indications that certain ingredients in 

these soaps may contribute to bacteWhen you’re buying 

soaps and body 

washes, do you reach 

for the bar or bottle labeled 

“antibacterial”? Are you 

thinking that these products, 

in addition to keeping you 

clean, will reduce your risk 

of getting sick or passing on 

germs to others? 

FDA Taking Closer Look 

at ‘Antibacterial’ Soap

rial resistance to antibiotics, and may 

have unanticipated hormonal effects 

that are of concern to FDA. 

In light of these data, the agency 

issued a proposed rule on Dec. 16, 

2013 that would require manufacturers to provide more substantial 

data to demonstrate the safety and 

effectiveness of antibacterial soaps. 

The proposed rule covers only those 

consumer antibacterial soaps and 

body washes that are used with water. 

It does not apply to hand sanitizers, 

hand wipes or antibacterial soaps 

that are used in health care settings 

such as hospitals. 

According to Rogers, the laboratory 

tests that have historically been used 

to evaluate the effectiveness of antibacterial soaps do not directly test the 

effect of a product on infection rates. 

Chemicals added to antibacterial soaps, 

such as triclosan, are listed on the Drug 

Facts label.
2 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 2013

Consumer Health Information

www.fda.gov/consumer

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That would change with FDA’s current proposal, which would require 

studies that directly test the ability 

of an antibacterial soap to provide 

a clinical benefit over washing with 

non-antibacterial soap, Rogers says. 

What Makes a Soap 

“Antibacterial?”

Antibacterial soaps (sometimes called 

antimicrobial or antiseptic soaps) 

contain certain chemical ingredients 

that plain soaps do not. These ingredients are added to many consumer 

products in an effort to reduce or prevent bacterial contamination. 

A large number of liquid soaps 

labeled “antibacterial” contain triclosan, an ingredient of concern to many 

environmental and industry groups. 

Animal studies have shown that triclosan may alter the way hormones 

work in the body. While data showing 

effects in animals don’t always predict 

effects in humans, these studies are of 

concern to FDA as well, and warrant 

further investigation to better understand how they might affect humans. 

In addition, laboratory studies have 

raised the possibility that triclosan 

contributes to making bacteria resistant to antibiotics. Such resistance 

can have a significant impact on the 

effectiveness of medical treatments. 

Moreover, recent data suggest that 

exposure to these active ingredients 

is higher than previously thought, 

raising concerns about the potential 

risks associated with their use regularly and over time. 

A Chance to Weigh In

FDA encourages consumers, clinicians, environmental groups, scientists, industry representatives and 

others to discuss and weigh in on 

the proposed rule and the data it discusses. The comment period extends 

for 180 days. 

In the meantime, FDA is emphasizing that hand washing is one of the 

most important steps people can take 

to avoid getting sick and to prevent 

spreading germs to others. Another 

good source for tips and information about benefits of appropriate 

hand washing is the Centers for Disease Control and Prevention (CDC). 

Consumers can go to www.cdc.gov/

handwashing. 

How do you tell if a product is antibacterial? 

• Most antibacterial products have 

the word “antibacterial” on the 

label; and

• A Drug Facts label on a soap or 

body wash is a sure sign a product 

contains antibacterial ingredients. 

Cosmetics must list the 

ingredients, but are not required 

to carry a Drug Facts Label.

FDA and EPA Working in Tandem 

on Triclosan

FDA and the Environmental Protection Agency (EPA) have been closely 

collaborating on science and regulatory issues related to triclosan. This 

joint effort will help to ensure government-wide consistency in the regulation of the chemical.

The two agencies are reviewing the 

effects of triclosan from two different 

perspectives. 

EPA regulates the use of triclosan 

as a pesticide, and is in the process of 

updating its assessment of the effects 

of triclosan when it is used in pesticides. FDA’s focus is on the effects of 

triclosan when it is used by consumers on a regular basis in hand soaps 

and body washes. By sharing information, the two agencies will be better able to measure the exposure and 

effects of triclosan and how these 

differing uses of triclosan may affect 

human health. 

For more information on EPA’s 

most recent assessment of triclosan, 

see: www.epa.gov/pesticides/reregistration/triclosan/triclosan-questions.htm

EPA re-evaluates each pesticide 

active ingredient every 15 years. EPA’s 

Preliminary Work Plan for the triclosan risk assessment, can be found in 

docket EPA-HQ-OPP-2012-0811 at 

www.regulations.gov.

A large number of liquid soaps labeled 

“antibacterial” contain triclosan, an ingredient 

of concern to many environmental

and industry groups.