Food safety advocates recently petitioned the FDA to ban it, decades after studies found that high doses of the artificial dye could cause cancer in rats. This is what you need to know.
Food products may still contain red number dye. 3.
By Lauren Kirchner
More than 30 years ago, the Food and Drug Administration (FDA) told the cosmetics industry that it could no longer use an artificial colorant called FD&C number red. 3, also known as red dye number 3 and red dye 3. This was because high doses of this dye had been found to cause cancer in animals.
At that time, however, the same ingredient was still permitted for use in foods, as it had been since 1907. And it remains permitted to this day. It is used in thousands of food products, including candy and drinks, as well as medicines that children and adults take, sometimes daily.
Last month, the Center for Science in the Public Interest (CSPI), a health and food watchdog group, sent a petition to the FDA urging the agency to ban red dye number 3 in foods, dietary supplements and medications. ingested. Consumer Reports signed it, along with 20 other advocacy groups and three individuals.
Below is some background on this dangerous dye, and the strange reason we continue to eat and drink red dye number 3.
What is red dye number 3 and why is it so worrying?
Erythosine, listed as FD&C red number 3 on some ingredient lists, is a synthetic petroleum-derived dye that gives foods and beverages a bright cherry red color. For decades, the FDA has been aware of multiple studies showing that it can cause cancer in animals. According to studies, laboratory rats fed high doses of dye for long periods developed thyroid tumors.
The International Association of Dyestuff Manufacturers (AIMC), an industry group, maintains that red dye number 3 is safe at the levels people typically consume and that studies in humans are more relevant than studies in laboratory rats. (like the ones that led the FDA to ban it in cosmetics). The group has stated that findings linking the dye with behavioral problems are “based on insufficient evidence.” In an email to CR, Meredith Huddle, AIMC communications director, also said that a 1987 study found that even high doses of red dye number 3 have “no effect” on humans because “it is poorly absorbed.”
But numerous research suggests the opposite. For example, several studies have linked some artificial food dyes, such as red dye number 3, to hyperactivity and other neurobehavioral effects in children. In double-blind studies, their diets were monitored for several weeks in a row, first without any artificial color additives and then with them, in different doses. Not all children were noticeably affected, but those who appeared to be most sensitive to the dyes showed more inattention, hyperactivity, and restlessness even with a small amount, just 1 mg a day, than when they were on diets without dyes.
What foods and medications contain red dye number 3?
Many! According to a search of the Environmental Working Group’s food database, there are more than 2,900 food products that contain it. It is present in many candies with artificial flavors and colors, and in some gummies, peppermints, and corn candies. Be careful with him, especially around Valentine’s Day. It may be an ingredient in those iconic heart candies with phrases on them made by Spangles, Brach’s and other companies.
And it is also present in many other foods and drinks. Some things that contain it may not be surprising, like the strawberry flavors of Nesquik, Pediasure, Ensure, and Yoo-hoo. But there are also others you might not expect, like Vigo saffron rice, Wise onion rings, and Morningstar Farms vegetarian bacon.
It also appears in some medications and supplements, such as cough syrups and gummy vitamins. It is ironic that, given its possible relationship with inattention and hyperactivity in children, red dye number 3 is an inactive ingredient in Vyvanse, a medication commonly prescribed for attention-deficit/hyperactivity disorder.
Who can be affected the most by red dye number 3?
Food safety experts and advocates say that while it is likely to pose risks to people of all ages, young children may be the most vulnerable. “Young children are the most affected because of their small body weight and because they are exposed to many more of these dyes in foods,” says Dr. Tasha Stoiber, senior scientist at the Environmental Working Group.
This is concerning because many of the foods and medications that contain it are actively marketed, and actively consumed, by young children. According to FDA estimates, American children ages 2 to 5 consume twice as much red dye number 3 as the general population in terms of body weight.
Stoiber says even small amounts of the dye can add up and pose a risk to children. “It’s not inconceivable that you could eat a few servings of something and reach the amount that has been shown to have these effects in human studies,” she says.
How can you and your family avoid red dye number 3?
Here’s some good news: The FDA requires manufacturers to list red dye number 3 as an ingredient on the food label. So, if you are going to buy candy, you can always look for this coloring in the ingredients list (“FD&C Red number 3) to know which products you should avoid. Candies with bright colors and a fruity flavor usually contain this coloring more frequently than other types of candies.
It will also be listed as “inactive ingredients” on the medication bottle, or you can look for “dye-free” versions of some medications.
The short answer: bureaucracy, apparently. As the recent petition to the FDA says: “There is no scientific or public health justification for allowing the use of FD&C red number 3 dye in foods while it is prohibited in cosmetics and externally applied medications.”
Instead, it is largely the result of complicated internal FDA processes. The list of color additives that the agency allows in foods, supplements, and ingested medications (such as pills and liquid drugs) is different from the list of cosmetics and applied drugs (such as prescription lotions). That means the FDA has had to make decisions about the safety of each type of use at different times.
The agency approved the use of red dye number 3 in foods and supplements before approving its use in cosmetics. When the FDA had to make a decision on whether to permanently approve its use in cosmetics in 1990, it had sufficient evidence from scientific studies showing that it caused cancer in laboratory rats. So the FDA banned red dye number 3 in all cosmetics. But at that time, the color was already on a list of permanently approved foods.
What happened then? At the time, the FDA said it would “take action” to ban it from food as well, but then did not do so. When CR asked the agency to explain its lack of action in 32 years, officials did not respond directly, but wrote: “The FDA evaluates and approves color additives for certain uses, based on the most up-to-date science available at the time. “Following our initial evaluation, our scientists continue to review relevant new information to determine whether there are safety concerns and whether the substance is no longer safe for use under the Federal Food, Drug, and Cosmetic Act.”
“Regardless of the reason it’s taken so long, it’s absurd that it’s taken this long,” says Dr. Thomas Galligan, senior scientist for food additives and supplements at CSPI and one of the authors of the group’s petition to the FDA. “In 32 years, there are millions and millions of children who have been exposed to this chemical without needing to be exposed.”
Are other types of artificial colors in foods and medicines also bad for your health?
The current petition to the FDA focuses on red dye number 3 because there is a lot of evidence of its harmfulness and because the FDA itself has already determined that it is carcinogenic. But food safety experts are also concerned about other artificial colors. For example, studies of children’s exposure to FD&C Red Number 40, FD&C Yellow Number 5, and FD&C Yellow Number 6 (PDF) have shown similar effects on neurobehavior.
In general, we would recommend skipping all of those [colorantes artificiales]because of its impacts on younger children,” says Stoiber of the EWG.
What do food safety experts think needs to happen now?
The petition to the FDA urges the agency to immediately remove red dye No. 3 from its list of approved ingredients. When asked to comment on how it might respond, a spokesperson said the agency does not comment on pending petitions.
Food safety experts and advocates say they are simply resurrecting a determination the agency itself made about the ingredient long ago.
“This petition asks them to finally do what they said they were going to do 32 years ago, and ban red 3 in food and in ingested medications and supplements,” says Galligan. “In our opinion, this is a very open and shut case.”
Editor’s note: This article, originally published on November 14, 2022, has been updated to remove Dole Fruit Cups from foods with red number 3 dye after the company informed CR that it had removed the ingredient from the product as of March 2023.
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