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.”