Madeleine + Red Dye 40 = Horror Show

Several months ago, my three-year-old daughter Madeleine had an allergic reaction so my mother gave her some children’s allergy medicine—a generic version of Benadryl. As my daughter awakened from the late nap/coma that ensued, she writhed and groaned like an angry, wounded animal. My mother and I looked at each other with concern—for ourselves. “I hope she stays asleep,” I half-joked. When more guttural sounds issued from little Madeleine causing our eyes to widen, I said, “Maybe we should call the Exorcist.”

When Madeleine finished waking up she wanted to eat so I put her in her high chair and gave her a piece of pizza. This made her furious. She wanted two pieces on her plate, not one! Red-faced and crying, she screamed as loud as she could. I was just glad she was strapped in the highchair and that she couldn’t hurt herself or me. This was no longer a joking matter. My daughter had become someone else.

Mom and I couldn’t fathom what had changed her personality so drastically and we felt incapable of soothing her. We just kept looking at each other in confused terror. After our nerves could take no more, I stuffed Madeleine in her car seat and left for home. She screamed at me non-stop for several miles until she was too exhausted to continue. Any parent knows it’s not unusual for children to overreact, and my daughter is not above a good temper tantrum, but this was beyond anything I had ever witnessed—in her or in anyone else.

This was our Friday night. As the weekend wore on, Madeleine remained aggressive and peevish. She woke up both nights yelling, kicking and hitting me in her sleep. On Sunday afternoon Madeleine, attempting to draw, was stabbing the paper with her markers, gouging holes in it. I said, “Honey, what’s wrong?” (As though she could really tell me at her age.) “I DON’T KNOW!” she yelled as she gouged, tears coming down her cheeks. By Sunday night we were both exhausted. I actually considered taking her to emergency room that weekend, but I was afraid they’d lock her up. Or at the very least try to medicate her, or possibly misdiagnose her as having ADD. Turns out, this was no overreaction on my part.

I told a friend about Madeleine’s condition, and she told me about scientific studies involving children reacting badly to preservatives. Madeleine had been eating bread all weekend—bread was the only thing she would eat. I Googled the issue and found that calcium propionate, a preservative in contention among parents and researches, was an ingredient in the bread she’d been eating. I stopped giving her any preservatives, but my mother was not convinced we had solved the problem. Knowing the change occurred in Madeleine after the dosage of generic Benadryl, my mother woke at four in the morning on Monday and Googled the ingredients in the Kroger brand Madeleine had taken. The first ingredient: citric acid. The second: Red Dye 33. The third: Red Dye 40.

Red Dye 40 is the #1 food dye used in the world, prevalent in most any unnaturally red foods. Basically, if it’s red, it’s probably Red 40. But beware of brown and blue and orange things too. Without Red 40, Jell-O chocolate instant pudding would look green (because there’s not really any chocolate in it) and Ocean Spray’s Ruby Red Grapefruit juice would lack that reddish hue. (See Sidebar #4 for more products containing Red Dye 40.) Red 40 is especially prevalent in candy, where the concomitant sugar intake is presumed the culprit, and in children’s medicines. Pedialyte popsicles, for example, designed to replenish fluids in dehydrated children, contain Red Dye 40. Tylenol offers dye-free liquid medicine for children, and Benadryl makes a dye-free version of their allergy medicine as well. Madeleine has never balked that her cherry-flavored medicine didn’t look red, so why do these manufacturers continue making the colored version? Would eliminating it be committing mea culpa? Isn’t it a mea culpa to make the dye-free version at all?

Also known as Allura Red AC, Red 40 has been banned in Denmark, Belgium, France, Germany, Switzerland and Australia. According to an October, 2008 article in the Los Angeles Times, the UK has now declared a ban on Red 40—and seven other dyes.

And yet, according to that same article, many psychologists and food scientists aren’t convinced there’s a problem. Even though some children are known to have bad reactions to Red 40, namely hyperactivity and aggression, the key word here is some children.

How do we convince food scientists that some are enough? Do we let scientists give Madeleine some Red 40 and watch her go? Had I been able to think straight that weekend, I would have videotaped her and put the footage on YouTube. I would have gladly sent the YouTube link to Kroger, to Allied Chemical—patent holders of Red 40—and to anyone with an email address at the Food and Drug Administration (FDA).

The Red 40 Scare is Not a New One

For decades, researchers and parents have argued that food colorings and additives cause or exacerbate hyperactivity and other behavior disorders in children. In 1973, Dr. Benjamin F. Feingold, a pediatric allergist from California, proposed that preservatives, artificial sweeteners, artificial colors, and artificial flavors caused hyperactivity in children. He developed the Feingold Diet, which eliminates these items, and claimed that many patients with behavior problems improved on this diet—and he has had many believers. Though Feingold has since passed, his foundation continues his work. And Hyperactivity has since become a medically classified disorder known as attention deficit disorder (ADD) or as attention-deficit hyperactivity disorder (ADHD).

ADHD is the most common chronic psychiatric disorder of childhood.

Meanwhile, artificial food colorings have increased in use. And recently, scientists have taken up the topic with some intriguing results.

In 2004, after a review of thirty years of scientific studies involving food dye and behavior, Columbia University psychiatrist Dr. David Schab concluded, “The science shows that kids’ behavior improves when these artificial colorings are removed from their diets and worsens when they are added to the their diets. While not all children seem to be sensitive to these chemicals, it is hard to justify their continued use in foods—especially those foods heavily marketed to young children.”

Two newer studies have linked artificial dyes to hyperactivity in children who were not already diagnosed with hyperactivity. The first, conducted at the University of Southampton, involved 277 three-year-old children who were given a diet free of artificial colorings and benzoate preservatives for one week.

During the next three weeks, the children received either drinks containing artificial yellow and red colorings and the preservative sodium benzoate, or a placebo mixture. The scientists and the parents did not know which children received the artificial colors and preservative and which did not. Parents observed their children and measured behaviors. Results consistently showed “significant improvements in hyperactive behavior during the period when the diet did not contain benzoate preservatives and artificial colorings.” Parents reported worsening behavior in their children during the weeks when these ingredients were reintroduced. On the basis of this and other studies, in 2004 schools in Wales mandated foods containing these colors be withdrawn from school lunches.

The UK Food Standards Agency then commissioned a second study from the University of Southampton that made headlines on both sides of the pond when it was published last fall. In that study, 153 three-year-olds and 144 eight- and nine-year-olds were given drinks containing one of two different mixes of four artificial colors—the same ones tested before—plus Red 40 and Quinoline Yellow—and the preservative sodium benzoate, or a placebo. Research concluded, “The older children showed a ‘significantly adverse effect’ from both dye mixes, as measured by a parent rating of a list of behaviors including concentration, fidgeting, restless or ‘always on the go’ behavior, interrupting conversations or talking too much and fiddling with objects or their own body.” Notice that this doesn’t say some of the children.

Based on that study, in July 2008, the European Parliament voted in favor of adding a warning label on foods containing synthetic dyes, and the Food Standards Agency (The UK’s FDA) now recommends eliminating foods containing dyes from the diets of children who have ADHD.

As a member of the European Union, the UK cannot ban dyes on its own, however, the FSA has encouraged companies to voluntarily stop using the dyes. Mars (makers of Skittles) and McDonald’s have agreed to replace artificial dyes with natural alternatives—but only in their UK products. Now Kellogg’s strawberry Nutri-Grain Cereal Bars sold in the UK contain natural food colorings, beetroot red, annatto and paprika extract, while those sold in the US still contain Red 40, Yellow 6 and Blue 1.

If Red 40 has been banned extensively in Europe, why isn’t more being done in the US to prevent its use?

In a word: money. Red Dye 40 costs ten to twenty percent less than natural food dye alternatives, therefore companies won’t act unless the Food and Drug Administration enacts a ban or enforces a warning label on packaging. The FDA maintains that scientific research supports no health risks associated with food colorings.

On its website, the FDA sites a 1982 report concluded there was no “scientific evidence to support the claim that food dyes cause hyperactivity.”

And their website has their stance written loud and clear: “Reactions to color additives are rare. It is possible, but rare, to have an allergic-type reaction to a color additive. For example, FD&C Yellow No. 5 may cause itching and hives in some people. This color additive is widely found in beverages, desserts, processed vegetables, drugs, makeup, and other products. FDA requires all products containing FD&C Yellow No. 5 to identify it on their labels so that consumers who are sensitive to the dye can avoid it.”             In a recent article, FDA consumer safety officer Judith Kidwell was quoted as saying, “there’s no evidence of a connection between dyes and children’s behavior.” I can only conclude that she missed the LA Times article from two months ago.

Not only are they seemingly out of the loop on this front, but the FDA gets its funding from the industry it’s supposed to be regulating. This financing comes in the form of user fees when batches are tested. Philip J Hilts, author of Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, (Random House, 2003) explained it like this in a Frontline interview:

For the first 86 years of FDA’s existence, from 1906-1992, all of FDA’s funding came through the U.S. Treasury. Starting in 1992, unfortunately, a law was passed that said for a large proportion of the work done by the FDA on new drug applications, the money’s going to come directly, quid pro quo, from the industry. If they want a drug reviewed, they pay directly to the FDA to have the drug reviewed.

Policy and scientific study need to be mutually exclusive. Unfortunately, that is not the case right now. Hilts added, “The rules are quite tilted in the favor of industry. And so the critics of the FDA are correct in that it heavily favors industry. The companies have much more access and much more ability to go into the FDA and say, ‘We really want you to see this study the way we see it.’ And the consumers don’t have much ability to go in and do that.”

I asked Mr. Hilts what he thought about ways to affect a change on this issue. He said, “On Red Dye #40, yes, FDA is the key. The group that is most active on issues like this is the Center for Science in the Public Interest. I’d start with them.”

What Is Being Done

The Center for Science in the Public Interest calls artificial food colorings the “secret shame” of the food industry and its regulators, and that our exposure to AFCs has risen sharply in the last 50 years. Michael Jacobson, Executive Director of CSPI said in a recent article that the FDA is “at least 20 years behind the science.” CSPI also points out that the same panel that created that 1982 report referenced on the FDA website also reported this: “Some children already diagnosed as hyperactive and on a restricted diet experienced an increase in hyperactivity when given moderate doses of artificial food dyes and did not experience similar increases after receiving a placebo.” But that part isn’t on the FDA’s site.

On July 1, 2008, CSPI petitioned the FDA for a ban on eight artificial food colors; Blue 1, Blue 2, Green 3, Red 3, Red 40, Orange B, Yellow 6 and Yellow 5 (a.k.a. tartrazine—the color the FDA concluded is a known allergen to a small group of people.) The center is also asking the FDA to require warning labels on foods that contain the dyes—ones that are already listed on ingredient labels until the ban is in place—and to require neurotoxicity tests for new food dyes and additives.

Neurotoxins damage nervous tissue. Dr. Schab, the Columbia psychiatrist, concluded in his report that the dyes likely cause “neurobehavioral toxicity.” When I asked him why the reaction occurs in some kids and not others, he said, “It used to be considered an allergy-mediated response. However, the effects of AFCs now appear to be pharmacological ones.” In other words, artificial food colorings have a drug effect, the same way nicotine has a drug effect, or Vicodin. This is probably why AFCs have a greater effect on children; children are smaller. Dosage is a size-relative factor.

It is still unclear what the half-life of Red 40 is in the system, and therefore how long it takes to leave someone’s system. According to Dr. Schab, nobody knows whether or not the pharmacological effect of Red 40 can permanently alter one’s chemistry, the way lead paint does. But if it is a neurotoxin, then it could—according to the definition of a neurotoxin. I asked a Dr. Nick Gideonse, a teacher at Oregon Health & Science University, if it was possible for a pharmacological effect to be permanent. “It is entirely possible,” he said. “Just as it would be with certain pharmaceutical drugs, the effect could be permanent.” I used Skittles to potty-train my daughter. And who knows how much other stuff I gave her unwittingly. And we have no way of knowing how this has altered her, because we have no Madeleine control group available—a Madeleine who grew up dye-free.

What’s a Concerned Citizen/Activist and/or Parent to Do?

Contacting the FDA directly, if even it is possible, may not be the most effective route. Fran Hawthorne, author of Inside the FDA, (John Wiley and Sons, 2005) told one reporter, “What you need is a strong consumer/patient point of view to be an honest advocate to the FDA . . . hook up with other consumer groups and really know what you’re talking about. The scientists at the FDA tend to be dismissive of consumer groups as ill informed, and sometimes that is true.”

CSPI claims its petition has the backing of “19 prominent psychiatrists, toxicologists, and pediatricians” who co-signed a letter “urging members of Congress to hold hearings on artificial food dyes and behavior, and to fund an Institute of Medicine research project on the issue.” Giving CSPI an annual donation—perhaps every Halloween—would be a best effort. (For more ideas, see Sidebar #3.)

This Halloween I took my daughter trick-or-treating. As she picked through the options in the various neighbors’ baskets, I watched and advised, “That one has Red Dye 40. Better choose another one.” Madeleine, a three-and-a-half-year-old dressed as two of her favorite Disney princesses combined, just looked at me with the pained wisdom of a much older child, tossed the candy back in and chose again. No arguments. She doesn’t want the dye, no matter how tasty the packaging.

She hasn’t awakened in a screaming fit since our Red Dye 40 weekend. Though one night, she did sit up in bed and cry out. She was reaching up, as though to take something that was being given to her, and I asked what was wrong. In a truly sad voice she said, “I wanted that strawberry milkshake, but it was Red Dye 40.”

Now Christmas is coming. We ran into Santa at the mall and he gave Madeleine a candy cane. Of course I wouldn’t let her eat it. “It’s got Red Dye 40,” I said. “Then why did Santa give it to me?” she wanted to know.

That, my dear Madeleine, is a very good question.

<Sidebar #1> A Brief History of Food Coloring

  • The late 1800s: Manufacturers began coloring products with harmful mineral- and metal-based compounds. Some color additives contained arsenic or similar poisons. According to historical records, toxic food colorants resulted in injury or even death.
  • The early 1900s: Unmonitored color additives had arrived. More than 80 artificial coloring agents were used in popular food, some intended for coloring textiles, not food. Many color additives had never been tested for toxicity or other adverse effects. Most chemically synthesized colors were derived from aniline, a petroleum product that in pure form is toxic. These were dubbed “coal-tar” colors because the starting materials were obtained from bituminous coal, and are still used today for most certifiable color additives. Chemically synthesized colors simply were easier to produce, less expensive, and superior in coloring properties than natural options.
  • 1906: Congress passed the Pure Food and Drugs Act. This marked the first of several laws allowing the federal government to scrutinize and control the use of food coloring.
  • 1938: Passage of the Federal Food, Drug, and Cosmetic Act. The FDA’s mandate included the full range of color designations consumers still can read on product packages: “FD&C” (permitted in food, drugs and cosmetics).
  • Some time in the 1950s: scores of children contracted diarrhea from Halloween candy and popcorn colored with large amounts of FD&C Orange No. 1.
  • 1960: The 1938 law was amended to broaden FDA’s scope and allow the agency to set limits on how much color could be safely added to products. From the original 1960 catalog of about 200 provisionally listed colors, many were banned or discontinued, while the rest became permanently listed and are still used today.
  • 1971: A Russian study linked Red No. 2 to cancer. Red No. 2 was less expensive than Red No. 40, and manufacturers have to use 30 to 50% more of Red 40 to get the same effect. Consumerist pressure in the US resulted in an FDA ban on No. 2. Good news for Allied Chemical and No. 40.
  • Today: The FDA certifies use of over 11 million pounds of color additives each year. Of all those colors, Red No. 40 is by far the most popular.

<Sidebar#2>Neurotoxicity for Laypersons

  • Neurotoxins damage nervous tissue, which can disrupt or even kill neurons.
  • Neurons are the key cells that transmit and process signals in the brain and nervous system.
  • Neurotoxicity can result from exposure to radiation, drug therapies or abuse, exposure to mercury or lead, cleaning solvents, cosmetics, some naturally occurring substances, pesticides or food additives.
  • Symptoms may appear immediately after exposure or they may be delayed. Possible symptoms include limb weakness or numbness, memory loss, loss of vision or intellect, headache, sexual dysfunction, cognitive and/or behavioral disorders. Individuals with certain disorders may be especially vulnerable to neurotoxins.
  • The term ‘neurotoxic’ may be used more loosely to describe states that are known to cause physical brain damage but where no obvious neurotoxin has been identified.
  • Many substances exist which may impair neurocognitive performance without resulting n the death of neurons. This may be due to the direct action of the substance, with the impairment and neurocognitive deficits being temporary, and resolving when the substance is metabolized from the body.
  • In some cases, the level or exposure-time may be critical, with some substances only becoming neurotoxic in certain doses or time periods.
  • Prognosis depends upon the length and degree of exposure and the severity of neurological injury.
  • In some instances, exposure to neurotoxins can be fatal. In others, patients may survive but not fully recover. In other situations, individuals recover completely.

<Sidebar #3>What You Can Do

  • Contact your local congressperson and further the dialogue. Perhaps start with the suggestion that FDA funding not come from the industries it is intended to regulate.
  • If you feel your vote doesn’t count, your pocketbook might. You can enact a personal ban on any manufacturers who use Red 40. You may want to send them a letter to that effect as well.
  • If you or your child has a bad reaction, report it to the manufacturer as well as to CSPI.
  • Now that you’re informed, spread the word. One individual created a website devoted to providing education and information on Red Dye 40: http://www.red40.com
  • Inform your child’s school and teachers, daycare and babysitters.
  • Educate your children about what they should look for, so they know Red 40 is not something they should consume.
  • Meanwhile, avoid the dye(s). Red 40’s prevalence is astounding, and isn’t only in red foods. Always read the ingredient labels.
  • Buy dye free products, even if they cost more.
  • Additional information:

Action on Additives Campaign (www.actiononadditives.com)

Center for Science in the Public Interest (www.cspinet.org)

The Feingold Association (www.feingold.org)

Dye free candy canes: (www.NaturalCandyStore.com) (www.organiccandy.com)

<Sidebar #4>Common Products Containing Red Dye 40

Lucky Charms

Froot Loops

Reese’s Peanut Butter Puffs Cereal

Honey Bunches of Oats with Strawberries

Cap’n Crunchberries

Nacho Cheese Doritos

Welch’s Frozen Fruit Bars

Breyer’s popsicles; various flavors

Breyer’s strawberry shortcake ice-cream

Dannon fruit blend yogurts; most flavors

Campbell’s V8 Splash, strawberry kiwi flavor

Schweppes diet ginger ale

Minute Maid orange soda

Sunkist orange soda

Gatorade; various flavors

Kraft Catalina dressing

Kraft barbecue sauce; most flavors

Betty Crocker Hamburger Helper; lasagna

Del Monte fruit salad

Jolly Ranchers; various flavors

Nestle´ SweeTarts

Starburst; various flavors

Lifesavers; various flavor

Duncan Hines Cake Mix; golden, fudge marble, yellow

Duncan Hines Homestyle Frosting; vanilla

Quick strawberry milk

Pop-Tarts; chocolate chip, blueberry, strawberry, smores, etc.

Hostess Twinkies

Hershey’s strawberry and lite chocolate syrups

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