Health: FDA issues final rule on safety and effectiveness of antibacterial soaps

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FDA issues final rule on safety and effectiveness of antibacterial soaps

The U.S. Food and Drug Administration today 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 suggests that 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 andchloroxylenol (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 U.S. Centers for Disease Control and Prevention (CDC) recommendsthat 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.

The FDA, an agency within the U.S. Department of Health and Human Services, 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. The agency also is responsible for helping to ensure the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm
 
Antibacterial Soap? You Can Skip It -- Use Plain Soap and Water

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.

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[paste:font size="3"]EPA’s Final Work Plan for the triclosan risk assessment can be found in docket EPA-HQ-OPP-2012-0811.

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[paste:font size="3"]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.

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[paste:font size="3"]the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

September 2, 2016

http://www.fda.gov/forconsumers/consumerupdates/ucm378393.htm
 
It's amazing how Americans solve their problems.

To prevent infections, they recommended a product that sucked all of the moisture out of your hand so badly, it would lead to cracked skin -- the watering hole for infections.

As a nurse for over 10 years, a nurse who always stay with lotioned moisturized hands, thanks fda. Thanks for nothing.
 
that stuff is in EVERY major hospital restaurant and school
I grew up surrounded by healthcare professionals on my mother's side of the family - was always taught if you got to sanitize- use bleach on surfaces or iodine on skin.

other than that this and peppermint / castile soap is the only one I use when I really need to cut sweat and odor
Dettol-Products-.jpg
 
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It's amazing how Americans solve their problems.

To prevent infections, they recommended a product that sucked all of the moisture out of your hand so badly, it would lead to cracked skin -- the watering hole for infections.

As a nurse for over 10 years, a nurse who always stay with lotioned moisturized hands, thanks fda. Thanks for nothing.
I feel you. When I was a bedside nurse, I washed my hands 20 or 30 times a shift. Not including the hand sanitizer. Crazy how often we wash our hands. That shit became a habit even when at home
 
I feel you. When I was a bedside nurse, I washed my hands 20 or 30 times a shift. Not including the hand sanitizer. Crazy how often we wash our hands. That shit became a habit even when at home
And I've never caught anything from work, nor took something from work home. There's also the fact I keep those sick ass mothafuckas away from me.

I see these white nurses doing some of the nastiest shit ever. These new nurses engage in some of the riskiest behavior that I have ever seen.
 
I grew up surrounded by healthcare professionals on my mother's side of the family - was always taught if you got to sanitize- use bleach on surfaces or iodine on skin.

other than that this and peppermint / castile soap is the only one I use when I really need to cut sweat and odor
Dettol-Products-.jpg

Damn, you brought out the Dettol....you got to be Jamaican. Every Jamaican house had that. Was always in our bathroom
 
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