Decades Later, FDA Takes Action on Safety of Antibacterial Soaps

Oh, FDA...is there ANYTHING you won't approve without adequate testing to determine whether it's a health risk to the public? Public Service jobs don't pay well and have crazy turnover--gotta snag that cushy corporate corner office at one of the companies for whom you rubber stamp approval for everything they submit, doncha? Stack that paper!

Monday, December 16, 2013 by Common Dreams

“FDA is finally taking concerns about triclosan seriously."

- Andrea Germanos, staff writer


Commonly used antibacterial soaps are no better at killing germs than washing with plain soap and water, but may harm health and contribute to making bacteria resistant to antibiotics, the U.S. Food and Drug Administration announced Monday.

"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," Colleen Rogers, Ph.D., a lead microbiologist at FDA, said in a statement.

In its proposed rule issued Monday, the FDA states that makers of antibacterial soaps and body washes must now demonstrate the safety and effectiveness of those products, noting:

Several important scientific developments that affect the safety evaluation of these ingredients have occurred since FDA’s 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available. New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.

Environmental and public health watchdog groups have long sounded the alarm about triclosan, a common anti-bacterial agent.

In 2008, Environmental Working Group found that

Triclosan has been linked to cancer in lab animals, has been targeted for removal from some stores in Europe for its health and environmental risks, and the American Medical Association recommends against its use in the home. It is also linked to liver and inhalation toxicity, and low levels of triclosan may disrupt the thyroid hormone system. Thyroid hormones are essential to proper growth and development, particularly for brain growth in utero and during infancy.

Triclosan breaks down into very toxic chemicals, including a form of dioxin; methyl triclosan, which is acutely toxic to aquatic life; and chloroform, a carcinogen formed when triclosan mixes with tap water that has been treated with chlorine. Scientists surveyed 85 U.S. rivers and streams, and found traces of triclosan in more than half.

Other studies indicate that it contributes to antibiotic-resistant bacteria.

According to reporting by Bloomberg, "Chemicals like triclosan were never intended for mass consumer use."

The FDA first proposed removing triclosan from some products 35 years ago, the Natural Resources Defense Council points out, but no final action from the FDA meant its use continued and grew.

In 2010, the NRDC sued the agency to make it issue a final rule on triclosan. Monday's proposal comes as a result of a settlement from that lawsuit.

“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney in NRDC’s health program. “FDA is finally taking concerns about triclosan seriously."

While the proposed rule covers soaps and body washes, it leaves out products that don't use water like antibacterial wipes and sanitizers. The group Safer Chemicals Healthy Families points out that triclosan is widespread, and may also appear in products like toothpaste, cutting boards, yoga mats, textiles and household cleaners.

Scientists Warn of Low-Dose Risks of Chemical Exposure

Sunday, March 25, 2012 by Yale Environment 360

A new study finds that even low doses of hormone-disrupting chemicals — used in everything from plastics to pesticides – can have serious effects on human health. These findings, the researchers say, point to the need for basic changes in how chemical safety testing is conducted.

by Elizabeth Grossman

Since before the publication of Rachel Carson’s Silent Spring 50 years ago, scientists have known that certain synthetic chemicals can interfere with the hormones that regulate the body’s most vital systems. Evidence of the health impacts of so-called endocrine-disrupting chemicals grew from the 1960s to the 1990s. With the 1996 publication of Our Stolen Future by Theo Colborn, Dianne Dumanoski, and J. Peterson Myers, many people heard for the first time how such exposures — from industrial pollution, pesticides, and contact with finished consumer products, such as plastics — were affecting people and wildlife. Since then public concern about these impacts has grown.

In 2009, the American Medical Association called for reduced exposure to endocrine- disrupting chemicals. Last year, eight scientific societies, representing some 40,000 researchers, urged federal regulators to incorporate the latest research on endocrine-disrupters into chemical safety testing.

Last week, 12 scientists – including such experts as Colborn and the University of Missouri’sFrederick vom Saal — published a paper that they say significantly advances the debate. Their research, based on a review of 800 scientific studies, concludes that it is “remarkably common” for very small amounts of hormone-disrupting chemicals to have profound, adverse effects on human health. Hormone-disrupting chemicals, the paper explains, challenge a fundamental tenet of toxicology — “the dose makes the poison” — which contends that the greater the dose, the greater the effect. Hormone-disrupting chemicals don’t necessarily behave like this. Significant health effects, the researchers say, sometimes occur at low rather than high doses.

"Whether low doses of endocrine-disrupting compounds influence human disorders is no longer conjecture, as epidemiological studies show that environmental exposures are associated with human diseases and disabilities,” the paper’s authors write. The study, published in the journal Endocrine Reviews, maintains that the low-dose and special dose-response effects of hormone-disrupting chemicals means that “fundamental changes in chemical testing and safety determination are needed to protect human health."

The study’s lead author, Laura Vandenberg, a post-doctoral associate at Tufts University’s Department of Developmental and Regenerative Biology, said in an interview said that this low-dose and special dose-response behavior “should be expected of any chemical that acts like a hormone."

Not all experts in biology and toxicology agree with the study’s conclusions. Some scientists in academia, industry, and the U.S. Environmental Protection Agency said there is not yet convincing proof that extremely low doses of endocrine-disrupting chemicals have ill health effects or consistently produce low-dose effects that are not predicted by their effects at higher doses.

"There’s no question that both natural and synthetic compounds can mimic hormones,” said George Gray, director of the Center for Risk Science and Public Health at The George Washington University. But that a chemical produces effects at one level, no effects at another, and different effects at yet another level of exposure, “that’s not yet widely accepted in toxicology,” said Gray. “It’s something toxicologists are not yet convinced of and comfortable with,” he added.

Hundreds of such hormone-disrupting chemicals have now been identified, and exposure to these compounds is virtually ubiquitous. Among the chemicals the new paper discusses are bisphenol A, used in plastics, can liners, and receipt papers; common pesticides, including atrazine and chlorpyrifos; methyl paraben, a preservative used in cosmetics and personal care products; triclosan, an antibacterial agent used in soaps and toothpaste; nonylphenol, a detergent ingredient; the flame retardant PBDE-99; perchlorate, a fuel compound; and dioxin, an industrial and incineration by-product. The paper also cites DDT and PCBs — discontinued but very environmentally persistent compounds.

"This is the first time anyone’s tried to synthesize this whole field and show that this is not a single chemical issue,” Vandenberg said of the new study.

Very small amounts of hormones, including endocrine system hormones — those that regulate many of the body’s most important systems, among them development, metabolism, and reproduction — can have significant biological effects. So, it’s been discovered, can synthetic compounds with similar chemical compositions. Research indicates that exposure to a small amount of such a chemical at a particular stage of development can prompt effects that can impact not just that particular individual, but, in some cases, several generations.

"It’s not just sex hormones but also thyroid hormones, and insulin among others, that are involved,” said Vandenberg. “We’re really complicated instruments."

The health effects documented in the studies the paper reviews have been observed in live animal and cell culture studies and in human epidemiological studies. Their effects include adverse impacts on reproductive and sexual development and fertility; cognition and neurological systems; immune system function; and metabolic effects, including diabetes and obesity. 

“The weight of the available evidence suggests that EDCs (endocrine-disrupting chemicals) affect a wide range of human health endpoints that manifest at different stages of life, from neonatal and infant periods to the aging adult,” write the authors.

Hormones interact with cellular receptors like locks and keys, explained Vandenberg. The hormone or hormone-like chemical is the key, and the receptor, the lock. “Touch the receptor and it starts to produce a response,” said Vandenberg. Too much chemical stimulus (the wrong-size key), however, can overwhelm the receptor, causing it to shut down and produce no response.

A key concept of the paper is that endocrine-disrupting chemicals are non-monotonic, meaning that the responses of animals or people to the chemicals do not necessarily intensify or diminish based on the dose. To illustrate this concept, Vandenberg said, “Picture a line of people, where those on the left have no exposure and those on the right have the most exposure. For endocrine-disrupting chemicals, where the greatest effects occur may not follow that line of increasing exposure level from left to right."

While complex and challenging, the studies gathered in this paper demonstrate that this phenomenon is now well documented, say the authors. “I hope that this paper opens the door to the realization that the endocrine system is the overarching control system of all other body systems,” said Theo Colborn, president of the Endocrine Disruption Exchange, whose work has been instrumental in popularizing knowledge of endocrine-disrupting chemicals. “It controls how we develop, function, and reproduce from the moment we are conceived — in other words, the quality of our lives and our existence."

While epidemiological studies show environmental exposure to EDCs are associated with human diseases, linking a specific environmental chemical exposure to an individual’s health disorder remains difficult, particularly given the many variables that contribute to health outcomes — life stage, genetics, and other environmental factors.

"There are different susceptibilities in different populations that may cause very minute amounts of a hormone to prompt effects in some people but not others,” said Linda Birnbaum, director of the National Institute of Environmental Health Sciences, who was one of the paper’s reviewers. This literature, she said, points to the importance of investigating low doses and timing of exposure when assessing chemicals for endocrine and other hormonal health outcomes, she explained in an interview.

Some scientists think more research is needed to confirm how endocrine disrupting chemicals behave. L. Earl Gray, Jr., a research biologist at the EPA’s Reproductive Toxicology Branch, said these low-dose effects are “certainly biologically plausible.” But he questioned whether there is sufficient evidence to firmly establish the non-monotonic responses of endocrine-disrupting chemicals.

The American Chemistry Council (ACC), which represents chemical manufacturers, issued a statement saying that it “has committed substantial resources” to better understanding the potential effects of chemicals on the endocrine system, and cited a Michigan State University professor emeritus of toxicology who concluded that “low-dose effects have not been proven, and therefore should not be applied to real-world conditions and human exposures.” (Corporate shill, yeah?--jef)

To verify these effects, studies must prove the mechanism of these responses and be replicable, said Lorenz Rhomberg, principal at the Gradient Corporation, a private environmental and risk analysis consultancy. “In my experience that’s been lacking,” said Rhomberg, co-author of an ACC-funded study that found low doses of BPA to be without adverse human reproductive and developmental health effects.

But, said Vandenberg, that’s exactly what the new paper shows. “We don't just know that these effects occur, we know how they occur,” she said, noting that for some chemicals like BPA, non-monotonic responses are reported by dozens of labs.

Thomas Zoeller, a University of Massachusetts biologist and paper co-author, said that regulatory testing of chemicals for endocrine-disrupting impacts lags behind the growing evidence of the compounds’ health effects, particularly at levels to which people are routinely exposed. “There is a very large disconnect between regulatory toxicology and the modern science of endocrinology that is defining these issues,” said Zoeller.

How much will testing chemicals at low, environmentally relevant levels improve human health, the paper authors ask? While it’s not currently possible to quantify in dollars, current evidence “linking low-dose EDC exposures to a myriad of health problems, diseases, and disorders suggests that the costs of current low-dose exposures are likely to be substantial,” they conclude.

"People can easily get overwhelmed by this issue,” said Laura Vandenberg. “But from a public health perspective, we can’t see this problem as too big to deal with. We wouldn’t do that with any other medical problem.”

Are Your Clothes Making You Sick?

Anthony Gucciardi

Natural Society - December 29, 2011

With every form of industry slashing costs and utilizing potentially dangerous new manufacturing technologies in an attempt to monetize and reduce workload, many of these companies are putting your health at risk. Such is the case with the clothing industry according to new research, which asks the question as to whether or not your clothes may be making you sick.

Some corporations have begun embedding something known as antimicrobial compounds into a number of common products including toothpaste, hand soaps, and even items within the clothing industry. The antimicrobial compounds are added to kill germs and odors, which appears to be beneficial at first glance. The truth of the matter, however, is that scientists have found that these antimicrobial chemicals may actually be damaging your thyroid in addition to your hormonal system.

Triclosan, Nanoparticles Added to Clothing Pose Health Risk

Furthermore, these antimicrobial compounds do not really pack a powerful anti-odor or anti-germ punch. In fact, the antimicrobials added into premium brand name clothing items are actually the same as washing with soap and water. These products are sometimes loaded with harsh antibacterial agents such as triclosan, and trichlorocarban.

These two chemicals were found to begin washing out of the clothing quickly, and within around 10 washes half of the triclosan and triclocarban washed out. What this means is that the chemicals could easily be absorbed into your skin as a result of sweating or even from water touching the antimicrobial clothing. Washed out chemicals can also negatively impact the environment after passing through water treatment plants, posing a risk to wildlife, humans, and the food supply. The Swedish Chemical Agency, where researchers conducted the tests, also warned that children could absorb the microbial compounds which could negatively impact their developing bodies.

Silver can also be used in nanoparticle form, which are tiny particles that can cross the blood-brain barrier. Prominent health professionals have warned against products containing nanoparticles due to the fact that the technology has never been thoroughly tested for effects on human health.

How to Avoid These Products

Luckily, there are key indicators to look for that will help you avoid clothing loaded with antimicrobial compounds. Avoid homeware products and clothing marketed as anti-odor, antimicrobial, or antibacterial, and avoid personal care products that list triclosan or trichlorocarban on the ingredients label.

For optimum results, purchase 100% organic personal care products and clothing if possible. You can vote with your dollar, and you can deliver a message to companies adding health-threatening chemicals to their products by simply not buying them.

Studies on Triclosan, Used in Sanitizers and Soaps, Raise Concerns

FDA says Studies on Triclosan, Used in Sanitizers and Soaps, Raise Concerns

by Lyndsey Layton

The Food and Drug Administration said recent research raises "valid concerns" about the possible health effects of triclosan, an antibacterial chemical found in a growing number of liquid soaps, hand sanitizers, dishwashing liquids, shaving gels and even socks, workout clothes and toys.

The FDA and the Environmental Protection Agency say they are taking a fresh look at triclosan, which is so ubiquitous that is found in the urine of 75 percent of the population, according to the Centers for Disease Control and Prevention. The reassessment is the latest signal that the Obama administration is willing to reevaluate the possible health impacts of chemicals that have been in widespread use.

In a letter to a congressman that was obtained by The Washington Post, the FDA said that recent scientific studies raise questions about whether triclosan disrupts the body's endocrine system and whether it helps to create bacteria that are resistant to antibiotics. An advisory panel to the FDA said in 2005 that there was no evidence the antibacterial soaps work better than regular soap and water.

The FDA was responding to inquiries from Rep. Edward J. Markey (D-Mass.), who has been pushing federal regulators to take stronger action to restrict the use of triclosan and other chemicals that have been shown in laboratory tests to interfere with the delicate endocrine system, which regulates growth and development.

"The proliferation of triclosan in everyday consumer products is so enormous, it is literally in almost every type of product -- most soaps, toothpaste, cosmetics, clothes and toys," Markey said. "It's in our drinking water, it's in our rivers and as a result, it's in our bodies. . . . I don't think a lot of additional data has to be collected in order to make the simple decisions about children's toys and soaps that people use. It clearly is something that creates a danger."

Markey wants triclosan banned from all products designed for children and any product that comes into contact with food, such as cutting boards. Other countries, including the members of European Union, have banned or restricted use of the chemical.

Brian Sansoni of the Soap and Detergent Association, which represents the $30 billion U.S. cleaning products industry, said concerns about triclosan are unfounded.

"These products and ingredients have been reviewed, regulated and researched for decades," he said. "We believe the science strongly supports the safety and efficacy of these products. It's more important than ever that consumers continue to have access to these products. It's a time of increased threats from disease and germs."

Triclosan was developed as a surgical scrub for medical professionals. It is also used in pesticides. In recent years, it has been added to a host of consumer products to kill bacteria and fungus and prevent odors. It can be found in everything from kitchen cutting boards to shoes, often packaged with labels that tout "antibacterial" properties.

Most hand sanitizers, such as Purell, use alcohol and do not contain triclosan.

Sarah Janssen, staff scientist at the Natural Resources Defense Council, which joined with several other environmental groups last year to petition the FDA to restrict the use of triclosan, said the soap industry was taking advantage of consumer fears. "Especially with the H1N1 outbreak, people get really scared and think they need to take extra precautions without thinking that soap and water works just as well," Janssen said.

Because it is found in so many different types of products, triclosan is regulated by three different federal agencies: the FDA, the EPA and the Consumer Product Safety Commission. But the FDA, which oversees its use in personal-care products, medical devices and products that come into contact with food, has been working for 38 years to establish the rules for the use of triclosan but has not completed that task.

The FDA is committed to issuing the rules quickly and is working with EPA to review the most recent data on triclosan, said Doug Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research. He said the FDA is also revisiting the 1997 approval it gave for the use of triclosan in Colgate Total toothpaste because at the time, scientists had not yet raised concerns that triclosan can disrupt the endocrine system.

"For triclosan, the science is changing," Throckmorton said. "Based on what we know, we don't have evidence to suggest this chemical is a threat to human health. However, we have to understand better the health effects and we have to work with other agencies to collect that information and then decide whether or not we need to change how it's regulated."