What are Artificial Dyes?

Per the FDA, a color additive, as defined by regulation, is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body. Color additives are important components of many products, making them attractive, appealing, appetizing, and informative. Added color serves as a kind of code that allows us to identify products on sight, like candy flavors, medicine dosages, and left or right contact lenses. One of the U.S. Food and Drug Administration’s (FDA) roles is to assure that color additives are safely and appropriately used.

All color additives required to be listed by FDA fall into two categories: those that are subject to FDA’s certification process and those that are exempt from the certification process. Color additives subject to batch certification are synthetic organic dyes, lakes, or pigments. Those for food use are chemically classified as azo, xanthene, triphenylmethane, and indigoid dyes. Although certifiable color additives have been called coal-tar colors because of their traditional origins, today they are synthesized mainly from raw materials obtained from petroleum.

FDA has established regulations for color additives in Title 21 of the CFR, parts 70-82. The regulations in 21 CFR parts 73, 74, and 82 identify each listed color additive, provide chemical specifications for the color additives, and identify uses and restrictions, labeling requirements and the requirement for certification.

Types of Artificial Dyes

Color additives are classified as straight colors, lakes, and mixtures. Straight colors are color additives that have not been mixed or chemically reacted with any other substance (for example, FD&C Blue No. 1 or Blue 1). Lakes are formed by chemically reacting straight colors with precipitants and substrata (for example, Blue 1 Lake). Lakes for food use must be made from certified batches of straight colors. (One exception is carmine, which is a lake made from cochineal extract.) Lakes for food use are made with aluminum cation as the precipitant and aluminum hydroxide as the substratum. Mixtures are color additives formed by mixing one color additive with one or more other color additives or non-colored diluents, without a chemical reaction (for example, food inks used to mark confectionery).

For a comprehensive list of all FDA-approved color additives, including artificial dyes, go to the following FDA webpages: Color Additive Status List and Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices.

Troubled History

In 1927, responsibility for enforcing the Food and Drugs Act of 1906 was given to the newly established FDA. (The agency was first called the Food, Drug, and Insecticide Administration and was given its current name in 1930.) By 1931, there were 15 straight colors approved for use in food, including six of the seven in use today: FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigotine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Yellow No. 5 (Tartrazine), and FD&C Yellow No. 6 (Sunset Yellow).

Color Additive Amendments of 1960. In the fall of 1950, many children became ill from eating an orange Halloween candy containing 1-2% FD&C Orange No. 1, a color additive approved for use in food. That same year, U.S. House Representative James Delaney began holding hearings on the possible carcinogenicity of pesticide residues and food additives. These events prompted FDA to reevaluate all of the listed color additives. In the next few years, FDA found that several caused serious adverse effects and proceeded to terminate their listings. During that time, it also became clear that coal was no longer the primary raw material source for the manufacture of color additives.

After 1960, FDA gradually removed color additives from the provisional list either by permanent listing or by termination of listing. Today about half of the “1960” color additives remain listed; only color additive lakes remain provisionally listed and initiatives are underway to permanently list them.

Biological Events

When consumed, artificial dyes can interact with various biological systems. The exact effects depend on the specific dye and its concentration. Some of the notable biological events include:

Metabolism and Absorption

Absorbed in the gastrointestinal tract, some dyes, like Tartrazine (Yellow No. 5), can be metabolized by gut microbiota, producing metabolites that might influence gut health and systemic circulation. [source]

immune response

Certain artificial dyes can trigger immune responses in sensitive individuals, leading to conditions such as allergic reactions or exacerbation of asthma. This is particularly notable with dyes like Tartrazine and Allura Red (Red No. 40).​ [source]

Neurobehavioral Effects

Some studies suggest that artificial dyes may contribute to behavioral changes, particularly in children. Research indicates a potential link between artificial dye consumption and increased hyperactivity in children with ADHD​. [source]

Endocrine Disruption

Artificial dyes may interfere with hormonal systems. This can potentially lead to disruptions in thyroid function, reproductive health, and metabolic processes. [source]

Cancer Risk

Long-term exposure to high levels of certain artificial dyes has been linked to an increased risk of cancer in animal studies. For example, Red No. 3 has been associated with thyroid tumors in rats, leading to its ban in cosmetics but not in food and drugs. [source]

Liver Damage

Research has shown that certain synthetic chemicals, including artificial dyes, can lead to liver damage. Studies have linked dyes to elevated levels of liver enzymes, suggesting potential liver toxicity​. [source]

Oxidative stress

Artificial dyes, particularly those with certain chemical structures, can contribute to the generation of free radicals, which may lead to oxidative damage in cells and tissues. [source / source]

Polymorphisms

From FDA meeting minutes from a science board on artificial dyes:

“[A 2010 study] provides some important mechanistic evidence that may explain why some children react to dyes and some do not. And it has to do with polymorphisms in a histamine degradation gene.”

Data from a human study provide evidence for a mechanism involving the neurotransmitter histamine. The investigators demonstrated that polymorphisms in the histamine degradation gene for histamine-N-methyltransferase influences response to a dye mixture. In addition to its role in the inflammatory process, histamine is recognized for its role in regulating synaptic transmission alone and in concert with other neurotransmitters. [source]

In other words, researchers found that different versions of a gene that helps break down histamine can change how people react to artificial dyes. Histamine is important because it helps control brain signaling and also plays a role in inflammation. So, the study shows that histamine is involved in both brain function and how the body responds to certain substances.

Read the Ingredient Label

Artificial dyes on food and drug labels can appear under various names. Here are some common ones to look out for:

FD&C Colors

Indicates the dye is approved by the Food, Drug, and Cosmetic Act. Examples include FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Blue No. 1.

Color Additives

Sometimes, artificial dyes are simply listed as “Color Additive” or “Artificial Color.” Other generic terms like “Color Added” may be used.

Specific Color Names

These are specific names for dyes used in food products such as Allura Red AC (FD&C Red No. 40), Tartrazine (FD&C Yellow No. 5), Brilliant Blue FCF (FD&C Blue No. 1), and Sunset Yellow FCF (FD&C Yellow No. 6).

Color Index Numbers

The Color Index (CI) provides a unique number for each dye. For example, CI Food Red 40 (FD&C Red No. 40), CI Food Yellow 5 (FD&C Yellow No. 5), and CI Food Blue 1 (FD&C Blue No. 1).

Artificial Dye Examples

If you suspect you or your child has an artificial dye sensitivity, be sure to read all food and drug ingredient labels. Here are some examples of products that have artificial dyes listed on labels:

To Dye For: The Documentary

If you’d like to learn more, watch this incredible documentary about synthetic dye sensitivity featuring the world’s leading synthetic dye experts.

What is informed consent?

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