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When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected?
According to the U.S. Food and Drug Administration (FDA), there isn’t enough science to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. To date, the benefits of using antibacterial hand soap haven’t been proven. In addition, the wide use of these products over a long time has raised the question of potential negative effects on your health.
After studying the issue, including reviewing available literature and hosting public meetings, in 2013 the FDA issued a proposed rule requiring safety and efficacy data from manufacturers, consumers, and others if they wanted to continue marketing antibacterial products containing those ingredients, but very little information has been provided. That’s why the FDA is issuing a final rule under which OTC consumer antiseptic wash products (including liquid, foam, gel hand soaps, bar soaps, and body washes) containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.
Why? Because the manufacturers haven’t proven that those ingredients are safe for daily use over a long period of time. Also, manufacturers haven’t shown that these ingredients are any more effective than plain soap and water in preventing illnesses and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products, ahead of the FDA’s final rule.
“Following simple handwashing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” says Theresa M. Michele, MD, of the FDA’s Division of Nonprescription Drug Products. “We can’t advise this enough. It’s simple, and it works.”
The FDA’s final rule covers only consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers or hand wipes. It also does not apply to antibacterial soaps that are used in health care settings, such as hospitals and nursing homes.
Antibacterial soaps (sometimes called antimicrobial or antiseptic soaps) contain certain chemicals not found in plain soaps. Those ingredients are added to many consumer products with the intent of reducing or preventing bacterial infection.
Many liquid soaps labeled antibacterial contain triclosan, an ingredient of concern to many environmental, academic and regulatory groups. Animal studies have shown that triclosan alters the way some hormones work in the body and raises potential concerns for the effects of use in humans. We don’t yet know how triclosan affects humans and more research is needed.
“There’s no data demonstrating that these drugs provide additional protection from diseases and infections. Using these products might give people a false sense of security,” Michele says. “If you use these products because you think they protect you more than soap and water, that’s not correct. If you use them because of how they feel, there are many other products that have similar formulations but won’t expose your family to unnecessary chemicals. And some manufacturers have begun to revise these products to remove these ingredients.”
How do you tell if a product is antibacterial? For OTC drugs, antibacterial products generally have the word “antibacterial” on the label. Also, a Drug Facts label on a soap or body wash is a sign a product contains antibacterial ingredients.
Triclosan can be found in many places today. It has been added to many consumer products—including clothing, kitchenware, furniture, and toys—to prevent bacterial contamination. Because of that, people’s long-term exposure to triclosan is higher than previously thought, raising concerns about the potential risks associated with the use of this ingredient over a lifetime.
In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Some data shows this resistance may have a significant impact on the effectiveness of medical treatments, such as antibiotics.
The FDA and the Environmental Protection Agency (EPA) have been closely collaborating on scientific and regulatory issues related to triclosan. This joint effort will help to ensure government-wide consistency in the regulation of this chemical. The two agencies are reviewing the effects of triclosan from two different perspectives.
The 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. The 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.
The EPA reevaluates each pesticide active ingredient every 15 years. The EPA’s Final Work Plan for the triclosan risk assessment can be found in docket EPA-HQ-OPP-2012-0811.
The FDA’s rule doesn’t yet apply to three chemicals (benzalkonium chloride, benzethonium chloride and chloroxylenol). Manufacturers are developing and planning to submit new safety and effectiveness data for these ingredients.
With the exception of those three ingredients that are still under study, all products that use the other 19 active ingredients will need to change their formulas or they will no longer be available to consumers. Manufacturers will have one year to comply with the rule.
This rule doesn’t apply to hand sanitizers. In June 2016, the FDA issued a proposed rule requesting additional scientific data from manufacturers showing that the active ingredients in hand sanitizers are generally recognized as safe and effective to reduce bacteria on skin. To learn about the difference between consumer hand sanitizers and consumer antibacterial soaps, visit our consumer information page.
So what should consumers do? Wash your hands with plain soap and water. That’s still one of the most important steps you can take to avoid getting sick and to prevent spreading germs.
This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
September 2, 2016