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Are Anti-Bacterial Soaps Doing Their Job: FDA Says Maybe Not

Harold Mandel's picture
Cleaning up with soap and water

It's flu season and a lot of people are being mislead into thinking loading on the lather from anti-bacterial soaps will kill the flu. As a matter of fact it's a good idea to clean your hands well several times a day to help avoid the flu, common colds and other illnesses. However, it has recently surfaced that anti-bacterial soaps may have no added protection over other soaps to offer for cleaning up, and in fact may not be safe.

A proposed rule aimed at determining the safety and effectiveness of antibacterial soaps has been issued by the U.S. Food and Drug Administration on Dec. 16, 2013. The U.S. Food and Drug Administration has issued a proposed rule which would require manufacturers of antibacterial hand soaps and body washes to show that their products are safe for long-term daily use and that they are more effective than plain soap and water for the prevention of illness and the spread of certain infections.

It this proposal becomes law, companies that do not demonstrate such safety and effectiveness, would have to have their products reformulated or relabeled in order to keep them on the market. This move has been part of an overall more extensive review of antibacterial active ingredients by the FDA which has been aimed at ensuring that these ingredients are proven to be safe and effective. This proposed rule does not include hand sanitizers, wipes, or antibacterial products which are used in health care settings.

There are millions of Americans who use antibacterial hand soap and body wash products daily.
Consumers are generally lead to believe these products are effective tools to help prevent the spread of germs. However, at this time there is no evidence that these antibacterial hand soaps and body wash products are more effective at preventing illness than simply washing with plain soap and water. There are also concerns that long-term exposure to some active ingredients which are used in antibacterial products, such as triclosan, used in liquid soaps, and triclocarban, used in bar soaps, could be associated with health risks, such as bacterial resistance and hormonal effects.

Janet Woodcock, M.D., who is the director of the FDA’s Center for Drug Evaluation and Research (CDER), has pointed out that antibacterial soaps and body washes are being widely and frequently used by consumers in everyday home, work, school, and public settings, where there is actually a relatively low risk of infection. Dr. Woodcock has commented, “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.”

Practical concerns have prompted the decision by the FDA to reevaluate what data should be necessary to classify the active ingredients in consumer antibacterial products as “generally
recognized as safe and effective” or GRASE. There is widespread consumer use of antibacterial products coupled with accumulated scientific information and concerns which have been raised by health care and consumer groups.

Manufacturers who want to continue to market antibacterial products under the proposed new rule will have to provide the FDA with additional data on the safety and effectiveness of the products. Data would also have to be presented from clinical studies to show that these products are superior to non-antibacterial soaps for the prevention of human illness or for reducing infection.

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Sandra Kweder, M.D., who is deputy director, Office of New Drugs at CDER, has encouraged consumers to make educated choices about what products they choose to use while the FDA continues to collect additional information about antibacterial hand soaps and body washes. Dr. Kweder says, “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.” It is suggested that consumers continue to be diligent about washing their hands. When soap and water are not available it is advised consumers should use an alcohol-based hand sanitizer which contains at least 60 percent alcohol.

Just about all of the soaps which are labelled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients which are addressed in the proposed rule. Triclosan and triclocarban are the most common active ingredients which are present in antibacterial soaps. There are soaps which are labeled as deodorant which may also contain these ingredients. At this time the antibacterial soap products are not required to be removed from the market under the proposed rule.

However, as noted, when the proposed rule is finalized, either firms will have provided data to support an antibacterial claim, or if they have not done so, they will have to reformulate or relabel these products. With reformulation antibacterial active ingredients will have to be removed from the products. In relabelled products the antibacterial claim will have to be removed from the product's labeling.

Manufacturers of nonprescription anti-bacterial hand soaps and body washes will soon have to show that their products are safe for long-term daily use and that they are more effective than plain soap to stop the spread of infections, reports MedPage Today. The proposed new rule by the FDA does not apply to hand sanitizers and wipes, which are alcohol-based and are not used along with with water. The proposed new rule also does not include anti-bacterial products
which are used in the healthcare setting.

It is the desire of the FDA to amend a 1994 monograph which declared that just about all antiseptic active ingredients which are currently in use are "generally recognized as safe and effective." Anti-bacterial active ingredients have been under review by the FDA for the past several years. It is hoped the new rule will be finalized sometime in the fall of 2016. Dr. Woodcock says that there are greater than 2,200 anti-bacterial hand soaps and body washes which are currently available for consumers.

However, there remains no scientific evidence which shows that these products are any more effective at preventing illness than washing your hands with plain soap and water. Furthermore, it has been suggested from animal studies that daily exposure to such ingredients as triclosan and triclocarban can effect estrogen, testosterone, and thyroid hormones. The chemical ingredient triclosan can disrupt the endocrine system, which regulates growth and development, writes EmaxHealth reporter Denise Reynolds, RD.

The FDA wants manufacturers to conduct clinical trials which demonstrate that their products are more effective than plain soap and water for the prevention of illness and the spread of certain infections when they're used by consumers, if they want their anti-bacterial soaps and body washes to be considered as being generally recognized as effective. Similar clinical trials are wanted for safety issues. This is a serious issue, with Nicole Bouvier, MD, professor of infectious diseases at the Icahn School of Medicine at Mount Sinai in New York City, saying, triclosan is regarded as an "endocrine disruptor." The National Resources Defense Council has sued the FDA over failure to ban chemicals in antibacterial soap, reports Denise Reynolds, RD.

It has been my impression that consumers are definitely mislead into thinking that the words antibacterial and antimicrobial on various soap products confers a sense of a guaranteed increased effectiveness of these products. The fact that this simply may not be true coupled with the associated potential for negative health effects from the daily use of these products offers a justification for the proposed new rule dealing with these products by the FDA. At this time it is advisable to suggest to consumers that the most proven effective and safe manners to avoid getting sick and to prevent spreading germs to others remains washing up with plain soap and running water.



Defiantly we can not ignore the benefits of using antibacterial soaps. At the same time it become our responsibility to be aware of the presence of Triclosan which is dangerous for our health.