FDA issues final rule on safety and effectiveness of antibacterial soaps
SOURCE U.S. Food and Drug Administration
Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes
SILVER SPRING, Md., Sept. 2, 2016 /PRNewswire-USNewswire/ -- 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.
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 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.
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
Media Inquiries: Andrea Fischer, 301-796-0393, andrea.fischer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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©2016 PR Newswire. All Rights Reserved.Colgate Total Toothpaste Has Triclosan, A Cancer-Linked Ingredient — And Nobody Knew Until Now
Lauren Barbato
Imagine if the toothpaste you put in your mouth each day was linked to cancer cell growth. Would you still use it? If your answer is "probably not," then consider putting down that tube of Colgate tomorrow morning. Although approved by the FDA more than a decade ago, Colgate Total's triclosan ingredient has been linked to cancer growth in animals — except the public didn't know about it until now.
Bloomberg News reports that drug regulators are currently reviewing the dangers of triclosan, a commonly used household chemical that helps reduce bacteria contamination. According to the FDA, triclosan is found in antibacterial hand soap, kitchenware and children's toys, as well as one of the nation's bestselling toothpastes — Colgate Total. But the findings from Colgate Total's FDA approval process in 1997 show that the popular toothpaste may not be as safe as Colgate made it out to be.
The best part about this? The FDA didn't released the 35-page toxicology summary of Colgate Total and triclosan until early 2014, following a Freedom of Information Act lawsuit filed in 2013. After some pressing from Bloomberg News, the FDA also published the findings on its website.
The 35-page report provides a fascinating look beyond the Colgate Total label. In it, you'll find that the FDA was wary about certain Colgate claims, not only regarding the potential hazards of triclosan, but also that it can treat gingivitis — which the FDA points out isn't self-diagnosable — and eradicate plaque.
But as Bloomberg News points out, one of the biggest reveals is the fact that Colgate dismissed the triclosan experiments done on animals, calling them unnecessary:
Among the pages were studies showing fetal bone malformations in mice and rats. Colgate said the findings weren’t relevant. Viewed through the prism of today’s science, such malformations look more like a signal that triclosan is disrupting the endocrine system and throwing off hormonal functioning, according to the three scientists.
Included in Colgate's FDA application along with these experiment on animals was a study the company did on children and adults in the 1990s to prove triclosan was safe to human exposure in small, or proper, doses:
The applicant has adequately assessed the absorption of triclosan from an exaggerated dosing scheme. The resulting exposure level is well above that recommended by the FDA carcinogenicity advisory committee.
So, should we be worried? Well, the FDA says on its website that triclosan is "not known" to be dangerous to humans, but emphasis on the "not known" part. Although testing in animals doesn't always lead to the same effects in humans, these previous animal experiments have prompted the FDA to open up further research on triclosan. However, both the FDA and EPA stress that triclosan products such as soaps and toothpastes are currently safe to use.
From the EPA, which conducted its own triclosan assessment in 2008:
The Agency determined that, with the exception of preservative use of triclosan in paints and stains, pesticides containing triclosan met the statutory safety standard in FIFRA, provided that risk mitigation measures as outlined in the RED were implemented, confirmatory data gaps were addressed, and label amendments were incorporated as presented in the RED document. Subsequent to the issuance of the RED, the registrant of triclosan products for use in paints and stains voluntarily requested cancellation of the registration of products for these uses.
However, scientists say that it's not uncommon — or wrong — to second guess these common chemicals, especially since we're exposed to thousands of chemicals every day. “We have created a system where we are testing these chemicals out on the human population. I love the idea they are all safe,” UMass Amherst Professor Thomas Zoeller told Bloomberg News. “But when we have studies on animals that suggest otherwise, I think we’re taking a huge risk.”
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U.S. Bans Common Chemicals in Antibacterial Soaps, After Animals Developed Tumors and After Reckless Companies Refused to Provide Evidence that Such Products are Safe to Humans.
By Monique Brouillette on September 2, 2016
The U.S. Food and Drug Administration released its decision Friday on banning 19 active ingredients in antibacterial soaps. The ruling, 40 years in the making, caps a decades-long debate over whether these germ-busting chemicals are safe and offer any advantage over ordinary soap. The ban includes the most widely used antiseptic in hand soaps, triclosan—after a large number of studies have fallen short of manufacturers’ claims about its health benefits.
“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 a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
When it hit the market in the 1960s, triclosan was intended for use in hospitals. But consumer demand for antibacterial soap surged due to increased marketing and media reports on dangerous infections. So manufacturers started making such soaps available to the public and added antibacterials to other products including toothpaste, mouthwash, toys, clothing and more. It was not long until concerns about the safety and efficacy of the triclosan-based soaps arose, however, and as soon as the FDA began regulating over-the-counter drugs in the mid-1970s, it proposed banning triclosan. Yet the ruling was never finalized and the decision fell by the wayside. It was not until 2010 that the FDA—after the nonprofit Natural Resources Defense Council sued it over the long delay—imposed a series of deadlines to determine the safety of antibacterial consumer soaps, hand sanitizers and health care soaps.
So what has four decades of research determined? Most studies have focused on triclosan, and as far as human health is concerned the research into its toxic effects has produced mixed results. For nearly every study that shows triclosan has some particular effect, another shows it does not. Yet one thing is clear: Several clinical studies, following several hundred households, have shown that triclosan-based soap does not prevent illness any better than regular soap and water alone.
There is also significant evidence that triclosan might worsen the problem of antibiotic resistance. Whereas plain soap and water simply dislodge bacteria from skin, triclosan weakens and kills the microorganisms. Until recently it was thought that triclosan acted indiscriminately—killing all bacteria in a number of ways—but now scientists know that it targets specific molecular pathways, acting more like an antibiotic. For example, triclosan homes in on an enzyme that plays a key role in bacterial metabolism—the same pathway that the tuberculosis-fighting antibiotic isoniazid targets. This similarity has raised concerns that bacteria could mutate and grow resistant to triclosan—and therefore also to the antibiotic. Allison Aiello, an epidemiologist at the University of North Carolina at Chapel Hill, notes that several studies have shown that bacteria can become resistant to triclosan in a laboratory setting. For instance, one study found that up to 7 percent of Listeria strains isolated from the environment and food products were resistant to chemicals found in antibacterial soaps.
There is no definitive research on whether triclosan adversely affects human health, but animal studies suggest that exposure to it and similar chemicals has the potential to disrupt hormones in the body, trigger allergies and be associated with some types of cancer. Whether those effects translate to humans is unknown; as some experts explain, animals in experiments are exposed to much higher doses than humans would ever experience. Still, because there is potential for harm the FDA is responsible for seriously considering possible health effects. “When there are conflicts in the data, it’s better to concentrate on costs than to not,” says Kristi Pullen, an environmental health scientist at the Natural Resources Defense Council. These effects are of particular concern because so many people use antibacterial soaps, and the chemicals they contain can be absorbed through the skin. According to a 2004 study, 75 percent of Americans have triclosan present in their urine.
Triclosan has been linked to environmental concerns as well. Once antibacterial soaps get washed down the drain, the chemicals they contain can persist in nature for decades . And their reach is far—triclosan has been found in lakes, streams, oceans and even house dust. “The large-scale use of triclosan-containing products has not brought any measurable public health benefits but instead resulted in environmental contamination of water, dust, soil and biota in countries around the world,” says Rolf Halden, an environmental engineer at Arizona State University in Tempe. In fact, scientists in Minnesota discovered in 2010 that when triclosan is treated at wastewater plants, it can be converted to dangerous dioxins. These chemicals, which are in the same family as PCBs and pesticides, persist for years in the environment and pose significant health threats to humans and animals. Triclosan-generated dioxins were found in lakes throughout Minnesota as well as the Mississippi River. As a result the state decided last year to ban triclosan; the restriction goes into effect January 1, 2017.
The FDA had several years to sift through stacks of studies and weigh the risks and benefits of antibacterial hand soap, and based its decision on whether to ban specific active ingredients on safety and efficacy grounds. “No drug is all good or all bad,” says Bruce Hammock, a toxicologist at the University of California, Davis. He notes that animal studies are difficult to translate to human use, and continues: “Everything is a benefit/risk equation.” Still, Hammock says, because triclosan and other chemicals in antibacterial soaps show no benefit over plain soap they should not be used by the general public. Sarah Reisman, an organic chemist at the California Institute of Technology, echoes these sentiments. She contends that there are not enough benefits to justify exposing masses of people to chemicals that may be harmful.
Paul DeLeo from the American Cleaning Institute, a business organization that supports the cleaning products industry, says companies have already been phasing out triclosan—largely due to the Minnesota ban. When interviewed last month, DeLeo thought the FDA would ban the chemical due to the state prohibition in Minnesota and consumer pressure. U.N.C.’s Aiello and Stuart Levy, director of the Center for Adaptation Genetics and Drug Resistance at Tufts University and a consultant on the FDA’s advisory committee, also thought the FDA would decide to put a national ban into effect.
Even though triclosan and the other chemicals on the FDA’s list are now outlawed, products probably will not be free of antibacterials anytime soon. DeLeo says companies have substituted triclosan with three other chemicals that are unapproved by the FDA: benzalkonium chloride, chloroxylenol and benzethonium chloride. These chemicals have been given an extension to remain on the market for at least another year while companies gather evidence supporting their safety and efficacy. Health officials worry these antibacterials will have the same problems as triclosan. “Replacing one with the other doesn’t seem like it will solve the problem,” Reisman says.