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FDA Bans Chemicals Used In Antibacterial Soaps as Ineffective
6 September, 2016
The FDA just banned antibacterial soaps because they’re not safer or cleaner than regular soap. By Rebecca Harrington. aciencealert.com, September 05, 2016. The US Food and Drug Administration banned antibacterial soaps on Friday because they’re not better, cleaner, or safer than regular soap. "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, director of the FDA’s Centre for Drug Evaluation and Research said in the agency’s press release.
Niños lavándose las manos
"In fact, some data suggest that antibacterial ingredients may do more harm than good over the long-term," she added.
The ban applies to products with 19 active ingredients, including triclosan and triclocarban – two widely used antibacterial agents.
There’s "extensive literature suggesting that triclosan does not provide a benefit when used in a ‘real world’ setting compared to plain soap", Allison Aiello, an epidemiologist from the University of North Carolina who has published a review on several studies of triclosan tests, told Chemistry World.
One study, published in the Journal of Antimicrobial Chemotherapy in September 2015, compared soap containing triclosan with regular soap both in lab tests and on people’s hands.
The researchers exposed people to a type of common bacteria than can infect those with weakened immune systems, then had them wash their hands with triclosan and regular soap.
They found no difference between the two soaps.
In lab tests, the researchers also exposed 20 different kinds of bacteria to triclosan soap to see if it could do any damage there. It took nine hours to show any antibacterial effects.
While that was in test tubes, not on actual humans, that’s much longer than the 20 seconds the US Centres for Disease Control and Prevention recommends you take to wash your hands.
Multiple other studies have found that handwashing with antibacterial soap does not remove more bacteria or prevent more illnesses than washing with regular soap. They just work a little differently.
While regular soap works by mechanically removing germs from your hands, antibacterial soap contains chemicals that can kill bacteria or inhibit their growth. And apparently that old wash-off-the-germs method works just as well as kill-them-on-contact.
More harm than good
The US Food and Drug Administration first registered triclosan in 1969, and the chemical has been added to countless soaps, cosmetics and cleaning products since then.
But it turns out that triclosan soap is not just an equally effective replacement for ordinary soap – it may actually be worse than non-antibacterial varieties.
Studies have found that triclosan can increase bacterial antibiotic resistance, affect hormone regulation in animals and kill algae.
Triclosan is now in so many products that research has found it was washing down drains and building up in lakes and streams. That’s part of what prompted Minnesota to become the first state to ban the ingredient in 2014.
While more research is needed to determine triclosan’s safety in small doses, studies so far have shown that there’s no real advantage.
Now that the FDA has banned triclosan and antibacterial ingredients like it, the hope is that the chemicals will stop building up in the environment.
Plus, regular soap is just as good – so lather up.________________________________________________________________________________________________________________________________
Read also: FDA issues final rule on safety and effectiveness of antibacterial soaps. fda.gov. September 02, 2016. Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes. 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 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 U.S. 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.
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.
The ban applies to products with 19 active ingredients, including triclosan and triclocarban – two widely used antibacterial agents.
There’s "extensive literature suggesting that triclosan does not provide a benefit when used in a ‘real world’ setting compared to plain soap", Allison Aiello, an epidemiologist from the University of North Carolina who has published a review on several studies of triclosan tests, told Chemistry World.
One study, published in the Journal of Antimicrobial Chemotherapy in September 2015, compared soap containing triclosan with regular soap both in lab tests and on people’s hands.
The researchers exposed people to a type of common bacteria than can infect those with weakened immune systems, then had them wash their hands with triclosan and regular soap.
They found no difference between the two soaps.
In lab tests, the researchers also exposed 20 different kinds of bacteria to triclosan soap to see if it could do any damage there. It took nine hours to show any antibacterial effects.
While that was in test tubes, not on actual humans, that’s much longer than the 20 seconds the US Centres for Disease Control and Prevention recommends you take to wash your hands.
Multiple other studies have found that handwashing with antibacterial soap does not remove more bacteria or prevent more illnesses than washing with regular soap. They just work a little differently.
While regular soap works by mechanically removing germs from your hands, antibacterial soap contains chemicals that can kill bacteria or inhibit their growth. And apparently that old wash-off-the-germs method works just as well as kill-them-on-contact.
More harm than good
The US Food and Drug Administration first registered triclosan in 1969, and the chemical has been added to countless soaps, cosmetics and cleaning products since then.
But it turns out that triclosan soap is not just an equally effective replacement for ordinary soap – it may actually be worse than non-antibacterial varieties.
Studies have found that triclosan can increase bacterial antibiotic resistance, affect hormone regulation in animals and kill algae.
Triclosan is now in so many products that research has found it was washing down drains and building up in lakes and streams. That’s part of what prompted Minnesota to become the first state to ban the ingredient in 2014.
While more research is needed to determine triclosan’s safety in small doses, studies so far have shown that there’s no real advantage.
Now that the FDA has banned triclosan and antibacterial ingredients like it, the hope is that the chemicals will stop building up in the environment.
Plus, regular soap is just as good – so lather up.________________________________________________________________________________________________________________________________
Read also: FDA issues final rule on safety and effectiveness of antibacterial soaps. fda.gov. September 02, 2016. Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes. 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 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 U.S. 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.
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.