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Wednesday, March 28, 2012

Rethinking Autism As A ‘Whole Body’ Condition

THE AUTISM REVOLUTION: Whole-Body Strategies for Making Life All It Can Be
by Martha Herbert, M.D., Ph.D. with Karen Weintraub

Neurologist Dr. Martha Herbert, Harvard Medical School professor, director of Mass. General Hospital's TRANSCEND research laboratory and an authority on autism, has just published The Autism Revolution, which Kirkus Reviews calls, "An important book with implications broader than its specific subject."

You can order it from Amazon here.

In it, she advances an entirely new, and in some quarters, controversial, paradigm that regards autism not as an immutable, genetically-driven brain disorder, but rather, as a whole-body condition mediated by environmental and other influences and potentially responsive to treatment.

Or, as she asked in an influential 2005 paper in the journal Clinical Neuropsychiatry, is autism "a brain disorder, or a disorder that affects the brain?" And, if the latter, what roles do environment and nutrition have to play in the expression, diversity, severity and relief of symptoms?

Dr. Herbert's views on autism were informed not just by research, but also by many years of clinical experience working with children on the spectrum. As she puts it, "The more I worked with my patients, the more I realized I had a choice: to 'see what I believed,' or to 'believe what I see.' If I believed that autism was a genetically determined, lifelong brain impairment, then I would have to deny to myself the extraordinary capabilities and changes I saw in my patients. If I believed what I saw, then I would have to re-think everything I knew about autism." You may, too.

Here is a lengthy excerpt from her book, released March 27th by Ballantine Books:

Chapter 1: Go for the Extraordinary

Caleb tore himself away from a game with his sisters, bounced into the kitchen and asked his mom what she was making for dinner. It was one of his favorites: gluten-free pasta and ground beef.

He started to turn back to the girls, but paused. “Mom,” he said, as casually as if he were commenting on the weather, “my autism is gone.”

“How do you know?” his astonished mother managed to ask.

“It’s easy to be with people now,” the 10-year-old said matter-of-factly, and then headed back to his younger sisters.

Joy Petersen stared, dumbfounded for a few seconds in the middle of the kitchen. It wasn’t until two months later that she realized he was right.

Caleb has his father’s bright blue eyes, his mother’s dark hair and a complexion that reflects his mixed Dominican-American heritage. He is still looking up at 5 feet, and his voice remains a little boy’s for now. He wants to be a zoologist when he grows up, and is already talking about going away to college, although he understands that his parents will be sad to see him go.

She recently took him to a new doctor, a specialist in treating children with autism and other special needs. Caleb noticed the photographs covering the doctor’s wall, and asked why the doctor was holding a gun in one of them. After talking to Caleb and his parents for a while, the doctor announced that Caleb didn’t fit the criteria for autism anymore. “Yeah!” Caleb said, jumping up and pumping his arms. His mother began to sob uncontrollably.

Joy used to dream of the day someone would say her son was no longer autistic. Of the day he’d come up to her, say he loved her and really mean it.

That day was unimaginable when Caleb was 4, still had no language, and was so afraid that he would wail and cry when anyone other than his parents came within 5 feet. Joy said she would put her fingertips on his body and he would scream as if somebody had hit him. Taking care of Caleb was so overwhelming that she would often find herself in tears. There were times when she was so afraid of hurting him in her anger and stress, that she’d put him down, walk into her bedroom, shut herself in her closet and collapse on the floor, crying.

The doctors and therapists told her she had to be realistic. Your son will probably be like this forever, they said. You can try lots of different things, but none has been proven to work.

Joy decided to start trying them anyway. And to her surprise, everything seemed to work, at least a little. No one thing took the autism away, she said, but all of it put together helped a lot.

By the time Caleb was in first grade, everyone thought she’d succeeded. He was able to follow simple instructions. His repetitive behaviors – the spinning, stick tapping and high-pitched noises – had mostly stopped. He was able to sit in a mainstream classroom with an aide. This is as good as he’s going to get, they told Joy. You’ve done the best you can.

But she wasn’t satisfied. Her heart told her that there was more to do.

“I still had a disconnected boy,” she said.

“People would tell me he’s high functioning, he follows directions – and I’m like that’s not what I want…I want a boy I can look in the eye and I tell him I love him, and he knows what I’m saying…I want a boy who can look me in the eye and tell me he loves me…I want a boy who can take in the world and absorb it, not run away from it…Absorb it, not run away from it,” she repeats for extra emphasis.

She has that boy now.

See what we believe or believe what we see

For decades, doctors have told parents that autism was a genetic problem in their child’s brain, and that it wasn’t going anywhere – that they should expect their toddler’s troubles would be with him/her forever. Autism has long been defined by its deficits, by what the child is believed unable to do: communicate, control himself, function like everyone else. Parents might make improvements around the edges – reduce the tantrums, limit the crazy behaviors, get the child to follow directions – but the essential deficits would remain.

After years of researching autism and treating patients at Massachusetts General Hospital, after years of meeting children like Caleb, I have come to the conclusion that these views simply can’t be right.

I have met many, many people like Caleb who are doing remarkably well, often after making improvements more dramatic than anyone ever dreamed possible. Some showed amazing bursts of improvement, transforming from nonverbal and withdrawn to A-student with lots of friends. Some reached adulthood with a stable job and just a few quirks. Some still can’t talk but communicate through painting, music, glassblowing or eloquent words typed on a keyboard. Some, now adults, are professionals, parents, artists, friends, or all of the above.

It may be difficult to imagine now, as you are struggling to help a 4-year-old who screams more than he speaks, but many people with autism have grown up to lead fulfilling productive lives.

The more I worked with my patients, the more I realized I had a choice: to “see what I believed,” or to “believe what I see.” If I believed that autism was a genetically determined, lifelong brain impairment, then I would have to deny to myself the extraordinary capabilities and changes I saw in my patients. If I believed what I saw, then I would have to re-think everything I knew about autism.

That’s what I proceeded to do, and you are reading the result of that exploration.

For going on a decade and a half, I have thrown myself into taking a fresh look at autism. I have probed into generations of science, and compared the research with the theories built around this evidence. I have been inspired by a growing body of exciting new findings and new areas of research, which points to new ways of helping people with autism. And I have allowed myself to be touched by people with autism who offered me fresh perspectives and ideas and expanded my world.

More than genes and brain: also whole body and environment

In all my research and reading, I have never found proof of the genes-hopelessly-mess-up-the-brain-for-life model of autism. Genes absolutely affect the brain, but there’s no solid proof that they’re the only players.

Geneticists have been searching for autism’s “smoking gun” for more than a decade, but have only identified genetic “defects” in a small minority of people with autism – leaving the vast majority of autism genetically unexplained.

Meanwhile babies who seem normal for the first year or two, regress into autism. Scientists used to believe that all autism was caused by brain damage before birth. Some children with autism do seem different from the start. But a lot of children appear perfectly fine before slipping away over weeks or months. Studies of home videos and direct observations have confirmed that this occurs. Regression into autism makes it hard to just blame genes that kick in late, and makes you wonder about whether environmental stressors play a role too.

And many children do get better. There is no proof for the common assumption that if the diagnosis involves a genetic mutation – like Fragile X or Idic 15, or others presumed present but not found yet – that means the person is frozen with “impairment” and “deficits” for life. In 2008, I was among a group of researchers who published an article called “Can children with autism recover? If so, how?” Some of these researchers had shown that between 3 and 25 percent of children once diagnosed with autism are eventually told they do not have the condition. They gathered a group of scientists together to ask how this could happen. Their genes certainly don’t change in a few years, so they were either misdiagnosed or, like Caleb – who was rigorously diagnosed – after lots of treatment, their symptoms faded so much that they no longer belonged on the autism spectrum.

Autism can even change over minutes, hours or days – and then change back. Children with fever or on steroids for a medical problem like asthma can show improvements in communication and social interaction, which fade after the fever goes away or the steroids are stopped. If autism were totally genetically hardwired this couldn’t happen.

Meanwhile, genetics cannot explain the rising frequency of the condition. When I first got involved in autism research in 1995, people thought that 1 out of every 3,300 children had autism. As I write, the figures are approaching 1 in 100. Genes take generations to evolve, so either we have been oblivious to autism, or something other than genetics is causing autism more often. There is still some debate about whether autism is truly rising or whether factors like greater awareness and diagnosing people we would have missed in the past are causing the increase. But more and more reputable studies are finding that at least half of the surge can’t be explained away.

By now, most researchers agree that genes don’t act on their own to cause autism. Genes may lead to vulnerability – they may “load the gun” — but so much of the time, it’s environment that “pulls the trigger.”

Finally, although I’m a Harvard neurologist – an expert in the brain and nervous system – I have come to believe that just as autism is not simply a genetics problem, it is not simply a brain problem, either. Autism involves the whole body. As a physician, I’ve seen so many autistic children with similar medical problems that I can’t believe it’s just a coincidence. And we know through thousands of scientific papers and an ocean of clinical experience that the health of the body can affect the function of the brain.

At this point, I think there is enough evidence to say that while autism certainly involves the brain, it is really a problem of the whole body, including the brain, from molecules to cells, from organs to metabolism, from immune to digestive systems.

An autism revolution

If you add environment to genes, add body to brain, take seriously the powerful brilliance of many people with autism and the profound transformations and loss of diagnoses we are seeing more and more, you get a very different story than the “hopeless-genetic-lifelong-brain-damage” tale that most of us thought was the truth.

The story you get is of problems that can be solved, illness that can be healed, and extraordinary capabilities that can come out of hiding and make powerful impacts on the world.

Caleb got better because his mother was persistent and she believed in his full potential even when everyone told her he had improved enough. If he could really get better, how many other kids can get better too? How many others have hidden brilliance that the world needs to see? My commitment is to transform autism so everyone has their best shot at becoming all they can be. I know so many children like Caleb and so many brilliant and fulfilled people with autism that I feel ethically obliged to tell these stories so we can figure out what makes them possible. Armed with this knowledge, we can go forward and make this great opportunity accessible to as many people as possible.

We can’t afford not to have an autism revolution

It’s terrifying to imagine our future without this revolution.

The financial costs alone of raising our autistic children are staggering, with estimates ranging from $35 billion to $90 billion per year just in the United States. That assumes autism rates stop increasing, which they haven’t yet. And of course, children with autism usually grow into adults with autism, so those costs will be with us for decades if we don’t take action. At a time when America is still reeling from recession and when budget cutting seems to be the nation’s top priority, what will we do if there is not enough to go around to give everyone the help they need? Wouldn’t it be a good idea to address autism early and effectively?

If we continue to believe that autism is a lifelong hopeless condition we will be patient with slow progress because we won’t see how you might fundamentally help people. When we see people with autism improving, we will deny that they had autism to begin with. This kind of circular thinking breeds inertia, countless missed opportunities and lost dreams that damage not just the individuals who are left behind but the fabric of our whole society. More and more people will be autistic, more hearts broken and more counties and states bankrupted.

Now take a moment to envision a world where everyone believes that there are many parts of autism we can do something about, and that when people with autism are transformed, it is real and has something vital to teach us. Think about the energy and resources we would pour into tackling solvable problems. Imagine all the loving and happy family interactions, the creative brilliance unleashed and the benefit to all society.

Thousands of children like Caleb are teaching us the paths to success. They did it in spite of a system that told them they couldn’t, and shouldn’t. Imagine what we could do if we took these successes seriously and learned how to achieve them better and for many more people.

I believe that autism is not a genetic tragedy, but an unfolding and unprecedented catastrophe, related to many other health and environmental crises. Our world is making us sick. We need to build a world that makes us healthy.

Remember that for your child you are a path-breaker. You may become a path-breaker for others as well. The first step is perhaps the most potent: Take a stand with hope that your child can change, not just a little bit, but profoundly. Joy stayed firm with the vision that her son could get the most out of life. You can do this too.

Caleb got a lot better, many other children get a lot better, and your child may too. These experiences can teach others how to become healthy, move beyond autism, and fulfill their potential to be extraordinary.

Tuesday, March 20, 2012

Low Doses of Endocrine-Disrupting Chemicals May Have Big Effects

Scientists Seek "Fundamental Changes" in Testing and Regulation of Chemicals that Mimic Human Hormones

By Marla Cone and Environmental Health News

That is a main finding of a report, three years in the making, published Wednesday, 3/14 by a team of 12 scientists who study hormone-altering chemicals.

Dozens of substances that can mimic or block estrogen, testosterone and other hormones are found in the environment, the food supply and consumer products, including plastics, pesticides and cosmetics. One of the biggest, longest-lasting controversies about these chemicals is whether the tiny doses that most people are exposed to are harmful.

In the new report, researchers led by Tufts University's Laura Vandenberg concluded after examining hundreds of studies that health effects "are remarkably common" when people or animals are exposed to low doses of endocrine-disrupting compounds. As examples, they provide evidence for several controversial chemicals, including bisphenol A, found in polycarbonate plastic, canned foods and paper receipts, and the pesticide atrazine, used in large volumes mainly on corn.

The scientists concluded that scientific evidence "clearly indicates that low doses cannot be ignored." They cited evidence of a wide range of health effects in people – from fetuses to aging adults – including links to infertility, cardiovascular disease, obesity, cancer and other disorders.

"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," they wrote.

In addition, the scientists took on the issue of whether a decades-old strategy for testing most chemicals – exposing lab rodents to high doses then extrapolating down for real-life human exposures – is adequate to protect people.

They concluded that it is not, and so they urged reforms. Some hormone-like chemicals have health effects at low doses that do not occur at high doses.

"Current testing paradigms are missing important, sensitive endpoints" for human health, they said. "The effects of low doses cannot be predicted by the effects observed at high doses. Thus, fundamental changes in chemical testing and safety determination are needed to protect human health."

The report was published online in the scientific journal Endocrine Reviews. Authors include scientists University of Missouri's Frederick vom Saal, who has linked low doses of bisphenol A to a variety of effects, Theo Colborn, who is credited with first spreading the word about hormone-disrupting chemicals in the late 1980s and University of California, Berkeley's Tyrone Hayes, who has documented effects of atrazine on frogs.

The senior author is Pete Myers, the founder of Environmental Health News and chief scientist of Environmental Health Sciences.

Linda Birnbaum, director of the National Institute of Environmental Health Sciences, said the new report is valuable "because it pulls a tremendous amount of information together" about endocrine-disrupting compounds. Her agency is the main one that studies health effects of contaminants in the environment.

Birnbaum said she agrees with their main finding: All chemicals that can disrupt hormones should be tested in ultra-low doses relevant to real human exposures, she said.

In many cases, chemical manufacturers still are asking "old questions" when they test the safety of chemicals even though "science has moved on," she said. "Some of the testing paradigms have not advanced with the state of the science." Birnbaum wrote an editorial referencing the new report.

Nevertheless, for most toxicologists, Birnbaum said the report does not offer a big shift from what they are doing. The NIEHS already conducts low-dose testing of chemicals, including looking for multi-generational effects such as adult diseases that are triggered by fetal exposures.

"Some people keep slamming the toxicologists. But you can't paint everyone with the same brush," Birnbaum said.

However, the scientists who wrote the report said that low-dose science "has been disregarded or considered insignificant by many." They seemed to aim much of their findings at the National Toxicology Program and the U.S. Food and Drug Administration. The FDA in 2008 discounted low-dose studies when it concluded that bisphenol A (BPA) in consumer products was safe. Two years later, the agency shifted its opinion, stating that they now will more closely examine studies showing low-dose effects. The National Toxicology Program in 2008 found that BPA poses "some risks" to human health but rejected other risks because studies were inconsistent.

Several of the report's authors have been criticized by some other scientists and industry representatives because they have become outspoken advocates for testing, regulating and replacing endocrine-disrupting compounds. The scientists, however, say they feel compelled to speak out because regulatory agencies are slow to act and they are concerned about the health of people, especially infants and children, and wildlife.

Industry representatives say that just because people are exposed to traces of chemicals capable of altering hormones doesn't mean there are any harmful effects. They say that the studies are often contradictory or inconclusive.

In a statement, the American Chemistry Council, which represents chemical companies, said Wednesday that the industry "has committed substantial resources to advancing science to better understand any potential effects of chemical substances on the endocrine system. While we have not had an opportunity to fully review this paper, Michael Kamrin, emeritus professor of Michigan State University, has concluded 'low dose' effects have not been proven, and therefore should not be applied to real-world conditions and human exposures."

"Based on the evidence, it is concluded that these 'low dose' effects have yet to be established [and] that the studies purported to support these cannot be validly extrapolated to humans," Kamrin, a toxicologist, wrote in the International Journal of Toxicology in 2007.

But vom Saal and other scientists have said that tests that do not find low-dose effects of chemicals such as BPA are often industry-funded, and they often have tested the wrong animals or the wrong doses, or don't expose the animals during the most vulnerable time of fetal growth.

Endocrinologists have long known that infinitesimal amounts of estrogen, testosterone, thyroid hormones and other natural hormones can have big health effects, particularly on fetuses. It comes as no surprise to them that manmade substances with hormonal properties might have big effects, too.

"There truly are no safe doses for chemicals that act like hormones, because the endocrine system is designed to act at very low levels," Vandenberg, a postdoctoral fellow at Tufts University's Levin Lab Center for Regenerative and Developmental Biology, told Environmental Health News.

But many toxicologists subscribe to "the dose makes the poison" conventional wisdom. In other words, it takes a certain size dose of something to be toxic. They also are accustomed to seeing an effect from chemicals called "monotonic," which means the responses of an animal or person go up or down with the dose.

The scientists in the new review said neither of those applies to hormone-like chemicals.

"Accepting these phenomena should lead to paradigm shifts in toxicological studies, and will likely also have lasting effects on regulatory science," they wrote.

In the report, the scientists were concerned that government has determined "safe" levels for "a significant number of endocrine-disrupting compounds" that have never been tested at low levels. They urged "greatly expanded and generalized safety testing."

"We suggest setting the lowest dose in the experiment below the range of human exposures, if such a dose is known," they wrote.

Vandenberg said that there may be no effect or a totally different effect at a high dose of a hormonal substance, while a lower dose may trigger a disease.

The breast cancer drug tamoxifen "provides an excellent example for how high-dose testing cannot be used to predict the effects of low doses," according to the report. At low doses, it stimulates breast cancer growth. At higher ones, it inhibits it.

"Imagine taking 100 individuals that are representative of the American population and lining them up in order of exposure to an EDC [endocrine-disrupting compound] so that the person on the far left has the least exposure and the person on the far right has the most. For many toxic chemicals, individuals with the highest levels of exposure, at the right end of the line, have the highest incidence of disease. But for some EDCs, studies suggest that people in the middle of the line have the highest risk," Vandenberg said.

She compared hormones, which bind to receptors in the body to trigger functions such as growth of the brain or reproductive organs, to keys in a lock.

"The more keys that are in the locks, the more of an effect that is seen. But at some point, the locks are overwhelmed and stop responding to the keys. Thus, in the lower range, more keys equals more of an effect, but in the higher range, more keys equals less of an effect," she said.

Vandenberg predicted the report "will start conversations among academic, regulatory and industry scientists about how risk assessments for EDCs can be improved."

"The question is no longer whether these phenomena exist, but how to move forward and deal with them."

This article originally ran at Environmental Health News, a news source published by Environmental Health Sciences, a nonprofit media company.

We first reported here on concerns about BPA and other known endocrine disruptors in January, 2010. You can search this blog for more information or start reading here.

Friday, March 16, 2012

Possible Link to Autism: Parents' Workplace Toxic Exposures?

Could parental exposure to solvents at work be linked to autism spectrum disorders (ASD) in their children?

According to an exploratory study by Dr. Erin McCanlies, a research epidemiologist from the National Institute for Occupational Safety and Health (NIOSH), and colleagues, such exposures could play a role, but more research would be needed to confirm an association.

Their pilot study is published online in Springer's Journal of Autism and Developmental Disorders.

The experts' assessment indicated that exposures to lacquer, varnish and xylene occurred more often in the parents of children with ASD compared to the parents of unaffected children. Parents of children with ASD were also more likely to report exposures to asphalt and solvents, compared to parents of unaffected children. All of these exposures fall into the broader category of solvents, or solvent-containing products.

Autism spectrum disorders are characterized by, among other things, a number of brain abnormalities, which may be partly caused by genetic factors, but could also be the result of environmental or parental occupational exposures, according to earlier studies. These exposures have been associated with adverse pregnancy outcomes and other neurodevelopmental conditions in children.

The NIOSH researchers and colleagues used data from the Childhood Autism Risk from Genetics and the Environment (CHARGE) study at the UC Davis MIND Institute in Sacramento, CA. They carried out exploratory analyses to evaluate whether parents' exposure to chemicals at work may be associated with ASD in their children in a sample of 174 families -- 93 children with ASD and 81 with typical development.

Both parents took part in phone interviews, to assess exposures during three months prior to pregnancy, during the pregnancy, and up to either birth, or weaning if their child was breastfed. In addition, industrial hygienists independently assessed the parents' exposure levels for their particular job.

Dr. McCanlies comments, "Overall, these results add to the mounting evidence that individual exposures may be important in the development of ASD. However, these results are preliminary and are not conclusive. Additional research is required to confirm and extend these initial findings."

The researchers described the study as "a first pass screen from which results can be used to target future research directions and should therefore not be taken as conclusive." Further understanding will continue to come through studies that employ larger sample sizes and that investigate interactions between workplace exposures and genetic factors.

Tuesday, March 6, 2012

Canadian Study: Teens Especially Vulnerable to Concussion, Suffer More

Canadian researchers recently studied 96 male athletes who had suffered concussions in the three to nine months prior to both NHL-standard neuropsychological and electrophysical testing. They were divided into three groups: adults (30), kids aged nine - 12 (32) and teens aged 13 - 16 (34), and then compared with similar people who had not had a concussion.

Their report appeared February 28th in Brain Injury  journal.

The tests revealed that the injured teens exhibited greater deficits than either youger children or adults in attention span, impulsivity and short-term working memory--essential for reading and calculating. And their symptons typically lasted longer, too, often for six months to a year.

"Contrary to the belief by some parents and coaches that children can play through a concussion because their brains are more resilient, we find that children are more vulnerable to the effects of a brain injury than adults," said Lead Researcher Dave Ellemberg, a neuropsychologist at the University of Montreal.

And, teenagers suffer greater symptoms than either children or adults, he added.

"It's not that surprising," Ellemberg noted. "We know the adolescent's brain, more specifically the areas affected by the concussion, the frontal lobe areas of the brain, are growing in spurts, and when something is developing rapidly it is even more fragile to injury."

You can read more about this study here.

We have seen the effects of post-concussion syndrome first hand. All concussions are serious injuries that need to be treated by a qualified medical professional. We recommend that all high school athletes undergo imPACT or other baseline neurocognitive testing so that the severity of a concussion can be evaluated, and a determination made when it will be safe to return to play.

Do Artificial Food Dyes Adversely Affect Children's Behavior?

This is a question that's been around awhile without having been answered conclusively, or at least not to the satisfaction of the U.S.. Food and Drug Administration (FDA), the agency with regulatory responsibility for these inescapable chemicals. They are found in all sorts of everyday products popular with kids, from prepared foods to breakfast cereals and toothpaste.

Nine of these dyes are in common use, with Red #40, Yellow #5 and Yellow #6 comprising 90 percent of the market.

"They're really ubiquitous in this food supply that we've created," says Dr. David Wallinga of the Institute for Agriculture and Trade Policy.

Correlation Isn't Causation...

More than a dozen studies have already shown some correlation between food dye consumption and hyperactivity in children, with a reduction in symptoms corrsponding with changes in diet. Yet the FDA has voted against warning labels, and insists the question requires further review. Here's their unedited statement on the subject:
"Based on the data reviewed in the body of scientific literature, FDA last year concluded that a causal relationship between exposure to color additives and hyperactivity in children in the general population has not been established.

However, for certain susceptible children with ADHD and other problem behaviors, the data suggest that their condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, artificial food colors. Findings from relevant clinical trials indicate that the effects on their behavior appear to be due to a unique intolerance to these substances and not to any inherent neurotoxic properties.

FDA's Food Advisory Committee (a group of advisors from outside the FDA) met on March 30-31, 2011 to consider available relevant data on the possible association between the consumption of certified color additives in food and adverse behavioral effects in children. The committee was asked to advise FDA as to what action, if any, is warranted to ensure consumer safety from the use of these color additives in food. After receiving information from FDA, experts, and stakeholders, the FAC (1) found that existing data supported FDA's conclusion that there is not an established link between consumption of food dyes and adverse behavioral effects in children, (2) voted against the need for additional information on the product label of foods with color additives, and (3) recommended that additional safety studies be conducted. The FAC also recommended that a rigorous, comprehensive dietary exposure assessment of certified color additives be performed.

FDA currently is collecting data on the levels of color additives used in food. These data will be used to estimate dietary exposure for various populations, including children. Regarding the need for additional safety studies, FDA has begun a reassessment of the numerous safety studies conducted on certified color additives that are available in its files. Based on this evaluation, FDA will determine whether additional safety studies are needed."
The European Union, which sensibly embraced the so-called "precautionary principle" as the basis for its product safety regulations, years ago required warning labels on products containing artificial colorings.This action prompted many manufacturers, including Kellogg's, General Mills and Kraft,  to drop the dyes from their European recipes, lest their sales be adversely impacted. The upshot? Euro M&Ms are slightly duller in color than their American cousins. In other words, no biggie.

Do we really need these things?