Red Dye 3: Safety Concerns and Side Effects - Should You Be Worried?

Food additives and dyes are a common topic of research and discussion in the health and wellness field. Questions about food dye components, amount, and safety are on many consumer's minds. This is especially pertinent because daily artificial food dye intake per person is six times higher than in 1950. 

Red 40, Yellow 5, and Yellow 6 account for 90% of food dyes commonly consumed in the United States. Red dye No. 3, in particular, is a current topic of interest. Red No. 3 is a "color additive made from petroleum that gives food and drinks a bright cherry-red color." 

Consumers should be aware of the safety of dyes they may encounter daily. This article will describe Red No. 3 and its potential impacts on health and wellness. 

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What is Red Dye No. 3?

Red dye No. 3 is also called erythrosin B, and its chemical composition is C20H8I4O5. This means the dye consists of 20 carbon atoms, 8 hydrogen atoms, 4 iodine atoms, and 5 oxygen atoms. 

The Food and Drug Administration (FDA) defines a color additive as "any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body." The first synthetic dye was discovered in 1856, and federal regulation of color additives began in the 1880s. 

In the 1900s, many foods in grocery stores and beauty products were dyed with artificial colors. In 1927, several food dyes, including Red No. 3, were approved for use in food. By the 1960s, an amendment prohibited the use of color additives that were proven to be cancer-causing (carcinogen). Red dye No. 3 is approved for use in "foods generally." 

Why is Red Dye No. 3 a Concern?

There are concerns in the scientific community about the potential health effects of consuming Red No. 3. These concerns include:

• Possible cancer-causing activity
• Potential thyroid dysfunction
• Possible DNA damage
• Concerns about the impact on children's attention span

Older scientific studies have associated Red No. 3 with changes in genes, reduced clearance of dyes in the liver, changes in tumor necrosis factor (TNF), and an altered immune response. 

A recent study examined the effects of Red No. 3 (erythrosin B) on liver cells. The results showed that this food dye can damage cells in low and high amounts. Scientists examined the cells and found more damage in the groups that were given higher amounts of the dye (50.0 and 70.0 μg mL−1) compared to the group that didn't get the dye. 

This means the food dye damaged the cells' DNA after 4 hours of exposure. In another test, almost all the different amounts of the dye (except for the smallest amount, 0.1 μg mL−1) affected the liver cell's DNA. 

As with all exposures, the dose is related to the risk of health consequences. This is especially important in pediatric health because of children's lower body weight. 

A recent study examined the amount of food dye and children's health. It found that only about half of the samples with allowed colors stayed within the safe limit, and many candies, drinks, and bakery items had a dose over the safe limit. Some samples even had unsafe colors. 

A mix of colors in some products exceeds the acceptable daily intake (ADI), which could be risky for health, especially for children. The ADI for Red No. 3 in the United States is 0-0.1 mg/kg. 

Some studies examine the relationship between food dyes and children's behavior and attention. The analysis of multiple studies suggests that food dyes "May contribute significantly to some cases (of ADHD)." However, more research is needed considering sample size, control groups, age effects, and dosage. 

Regulatory Status of Red Dye No. 3

The current FDA stance on Red No. 3 is approval for food and ingested medications. This dye is not approved for use in beauty products or medications applied topically because rat studies have shown a possible increased cancer risk. 

The FDA states that "the law requires evidence that a color additive is safe under its intended conditions of use before it may be added to foods." When a dye is approved, the government specifies which dose it can be added and ensures that the additive is labeled correctly. 

Additionally, the FDA reviews new scientific information about the safety of food additives as they are published. 

In the European Union, Red No. 3 (Erythrosine) is permitted in lake form. A "lake" form of food coloring is made by combining the dye with aluminum salts, which prevent the color from dissolving in water.

The House Energy and Commerce Subcommittee on Consumer Protection and Commerce introduced an initiative in 2021 requiring the FDA to take a second look at all the food additives currently used. 

One of the arguments in this initiative is that many additives, including artificial colors, are introduced because they are Generally Recognized As Safe (GRAS), which does not require specific research about safety. Initiatives like this encourage the FDA to reassess the common ingredients in our food system to ensure safety. 

Foods and Products Containing Red Dye 3

Red No. 3 gives foods a cherry red color and is found in many common candies, snacks, and medications. Examples include cake decorating gel, popsicles, and some medications, including:

• Gabapentin 300 mg
• Omeprazole Delayed-Release 40 mg
• Sucralfate 1 gram

The FDA requires proper labeling of food dyes, and this color is listed as Red no. 3 or erythrosin. 

Why is Red Dye 3 Banned in Cosmetics but Not in Foods?

In 1990, the FDA denied the use of Red No. 3 in cosmetics and topical medications. This decision was based on the Delaney Clause, which "prohibits the approval of an additive if it is found to induce cancer when ingested by people or animals." The FDA approved this dye in food and ingested medications because limited data showed increased cancer risk in humans. 

Because it is a government agency, the FDA is not exempt from politics. The FDA's decisions are "governmental value judgments about competing goods and interests." Consumers should be aware of the potential political influences over regulatory decisions. 

How to Avoid Red Dye 3

Ingredient labels are required to list components by amount, and artificial dyes are not always explicitly labeled. When reading a food label, dyes may be listed as "artificial colors," their specific name (Red No. 3), or an alternate name such as erythrosine. 

There are many alternatives for artificial dyes, including pumpkin and carrot extract, strawberry extract, and other plant-based options. Many of these colors are derived from fruit and vegetables and are more commonly used in the United Kingdom. 

Plant-based alternatives for Red No. 3 include betacyanins (beet-derived) and anthocyanins (sweet potato-derived). When cooking and baking at home, plant-based food colors from berries and beets are an alternative. 

Are Other Artificial Dyes Also Harmful?

Other food dyes are commonly added to food, especially food marketed to children. A few of the most common are Red No. 40, Yellow 5, and Blue 1. These compounds contain benzidine, which may be associated with an increased risk of cancer.

Many studies about these dyes are conducted on animals, which are essential to consider but may not directly correlate to humans. Some individuals may be allergic to food dyes and develop symptoms like:

• Sneezing
• Skin rashes
• Anaphylaxis
• Hives
• Difficulty breathing
• Watery eyes

More research can help scientists assess more closely the effect these food dyes may have on humans. There are multiple ways to reduce intake of artificial dyes if that is your goal:

• Choose products with plant-based dyes.
• Purchase completely dye-free products.
• Cook and bake with plant-based food colors.
• Utilize an elimination diet to assess the effect of food dyes on behavior or allergies.

Industry Perspective

Artificial dyes are used to make food more appealing. The International Association of Color Manufacturers states that food dyes "provide a colorful identity to foods that would otherwise be virtually colorless and compensating for natural color loss." 

Colorless food tends to be less appealing, especially to children, and artificial dyes are inexpensive to manufacture. These are major reasons the food industry uses increasing amounts of dye, including Red No. 3.

Consumer Advocacy and Actions

If an individual consumer is concerned about food dyes and additives in their food, they can enact change on a personal and political level. Petitions are ongoing for the FDA to reevaluate these dyes, which is a great starting point for enacting change. 

Consumers can support organizations such as the Center for Science in the Public Interest and Consumer Reports if they want to become more involved.

What Do Experts Recommend?

Many experts, including pediatricians, recommend that parents educate themselves about artificial dyes and make informed decisions for their families. One of the best ways to avoid food dyes, including Red No. 3, is to focus on unprocessed foods. 

A strategy for integrating these foods is to shop the perimeter of the grocery store. Emphasize vegetables, lean proteins, fruits, and whole grains. Experts also recognize that it is difficult to tease out the individual effects of a food dye on a child versus the other ingredients, such as processed sugar. 

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Key Takeaways

• Many foods contain artificial dyes, like Red No. 3, which is commonly used but may have health risks.
• This synthetic dye is used to make food red and is approved for food but banned in cosmetics.
• Consumers should remember that food dyes' potential health hazards are often dose-dependent. 
• Studies link Red No. 3 to possible DNA damage, potential thyroid problems, and possible cancer promotion.
• Though concerns exist, the FDA still allows it in food, and there is a new emphasis on re-evaluating food dye safety.
• Experts recommend choosing natural food dyes and focusing on whole, unprocessed foods and reduced added sugar. 
• Consumers should discuss concerns with their healthcare provider, educate themselves about food additives, and make informed decisions regarding artificial dyes. 
• Further high-quality human research is needed to explore the effects of artificial food dyes on human health. 

The information provided is not intended to be a substitute for professional medical advice. Always consult with your doctor or other qualified healthcare provider before taking any dietary supplement or making any changes to your diet or exercise routine.