Released by the US FDA
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 US 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.
What Makes Soap ‘Antibacterial’
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 and Health Concerns
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.
More on the FDA’s Rule
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.
Consumers, Keep Washing with Plain Soap and Water
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.
Ed. Note: Below is an additional, shorter release from the FDA, also on September 2, 2016
FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps
Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes
Released by Andrea Fischer, fda.hhs.gov
The US Food and Drug Administration on September 2, 2016, issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.
This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use.
This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data that suggests antibacterial ingredients may do more harm than good over the long-term.”
The agency issued a proposed rule in 2013 after some data suggested that long-term exposure to certain active ingredients used in antibacterial products — for example, triclosan (liquid soaps) and triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects. Under the proposed rule, manufacturers were required to provide the agency with additional data on the safety and effectiveness of certain ingredients used in over-the-counter consumer antibacterial washes if they wanted to continue marketing antibacterial products containing those ingredients. This included data from clinical studies demonstrating that these products were superior to non-antibacterial washes in preventing human illness or reducing infection.
Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE). In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.
Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others. If soap and water are not available and a consumer uses hand sanitizer instead, the US Centers for Disease Control and Prevention (CDC) recommends that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
Since the FDA’s proposed rulemaking in 2013, manufacturers already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating (removing antibacterial active ingredients) these products.
For more information:
- Final Rule: Safety and Effectiveness of Consumer Antiseptics
- FDA Consumer Update: Antibacterial Soap? You Can Skip It—Use Plain Soap and Water
- FDA: Topical Antiseptic Products
- CDC: Handwashing: Clean Hands Save Lives
The FDA is an agency within the US Department of Health and Human Services that “protects the public health by helping to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.”
Ed. Note: For information on triclosan in other products, see this release by Beyond Pesticides.