Orange B Food Dye: Is it Safe or Should You Avoid It?

Food dyes have become ubiquitous in the modern food industry, used to enhance the visual appeal of a wide array of food products. According to a 2016 study that evaluated the content of artificial food colorings in 810 food products, over 90% of candies, fruit-flavored snacks, and drink mixes contain synthetic dyes. 

The Food and Drug Administration (FDA) regulates food additives and dyes in consumer products in the United States. Synthetic dyes must be manufactured according to guidelines outlined in the Food, Drug, and Cosmetic (FD&C) Act. The FDA has approved the use of nine synthetic food dyes (including Orange B) in food products. 

However, awareness of possible health risks associated with exposure to food dyes has been growing, especially since California's Office of Environmental Health Hazard Assessment (OEHHA) released a report in 2020 indicating that food dye consumption negatively impacts neurobehavioral outcomes in children. This article will evaluate the safety and potential risks associated with Orange B food dye, providing a comprehensive overview of its uses, health impacts, and regulatory status.

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Definition of Orange B Food Dye

Orange B food dye is a synthetic orange dye from the azo dye family. Azo dyes are the most used food dyes, accounting for approximately 70% of all artificial dyes. They are characterized by the presence of an azo group (a nitrogen double bond, –N=N–) in their chemical structure. 

Chemical Composition

Chemically speaking, Orange B is the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole. It is composed of two benzene rings connected by an azo group, with multiple sulfonate groups (a functional group consisting of a sulfur atom bonded to three oxygen atoms) that enhance its water solubility. Its molecular formula is C₂₂H₁₈N₄O₉S₂.

Uses of Orange B Food Dye

The FDA approved Orange B for use in the United States in 1966. Unlike some other artificial food dyes, the approved uses of Orange B are limited. It is only allowed in hot dog and sausage casings and cannot exceed 150 parts per million (ppm) by weight of the finished food. It is not approved for use in cosmetics or medications. (31)

Risks Associated with Orange B Food Dye

The safety of Orange B food dye has been a topic of debate. Various studies, primarily performed in animal models, suggest concern for potential health risks associated with consumption. 

Potential Health Risks

In general, the most common health concerns associated with food dyes include: 

• Hyperactivity in children
• Cancer
• Allergies

Synthetic food dyes may contribute to or exacerbate hyperactive behavior in children. This concern gained significant attention following the publication of the 1975 Feingold Diet, which proposed that eliminating artificial food colorings and certain food additives from children's diets could improve hyperactivity symptoms. 

In 2020, California's OEHHA released a report indicating that consumption of synthetic food dyes could negatively impact neurobehavioral outcomes in children, reinforcing the need for further investigation and potential regulatory review. The FDA reviewed the evidence and concluded that while the data suggest a possible link between certain food dyes and hyperactivity in susceptible children, the evidence is not definitive enough to warrant regulatory action. 

Orange B has been found to contain low levels of a carcinogenic (cancer-causing) contaminant linked to causing liver and bladder cancers in animals. Even small amounts of such substances can pose a risk over time, especially with chronic exposure. These findings have raised concerns about its safety in humans, particularly given the cumulative effect of long-term consumption. (20) 

While allergies to food additives are rare, research has linked additives (including food dyes) to allergic reactions. Clinical symptoms of food dye allergy are usually mild and related to the skin, including hives, swelling, and exacerbation of atopic dermatitis (eczema).

Populations at Higher Risk

Populations most vulnerable to environmental toxins include children, pregnant women, the elderly, and individuals with preexisting atopic (allergic) diseases. 

• Children are particularly vulnerable due to their developing bodies and higher consumption rates relative to their body weight, which can lead to greater exposure. 
• Pregnant women are also at significant risk as toxins can cross the placental barrier, potentially harming fetal development. 
• The elderly may suffer more due to weakened physiological systems and a reduced capacity to detoxify harmful substances. 
• Individuals with preexisting atopic diseases, such as asthma, eczema, or allergies, are at increased risk because their immune systems are already compromised, making them more susceptible to exacerbated symptoms and new sensitivities. 

Causes and Symptoms of Adverse Reactions

Adverse reactions to Orange B food dye typically stem from its interaction with the body's metabolic processes.

Mechanisms of Adverse Reactions

When ingested, the Orange B is metabolized by intestinal bacteria and liver enzymes. This metabolic breakdown results in the production of compounds called aromatic amines. Aromatic amines are commonly found in environmental chemicals associated with rubber, textile, and dye industries. These metabolites can induce oxidative stress and DNA damage, contributing to the dye's potential carcinogenic effects.

Side Effects of Orange B Food Dye

Symptoms of exposure to Orange B can vary, ranging from mild to severe. 

Acute symptoms may include: 

• Gastrointestinal discomfort, such as nausea, vomiting, and diarrhea
• Skin reactions
• Hyperactivity
• Irritability
• Headaches
• Difficulty breathing

Long-term exposure to Orange B and its metabolic byproducts may lead to more serious health issues, including: 

• Changes in urination
• Birth defects, as suggested by animal studies
• Cancer
• Damage to the spleen and bile ducts (20) 

Safety Regulations and Recommendations

In the United States, the FDA regulates and establishes guidelines for using food dyes, including Orange B. Orange B was first approved as a synthetic food dye in 1966. In the 1970s, the FDA proposed removing it from the list, citing concerns regarding research suggesting its carcinogenic effects. However, because manufacturing of Orange B stopped in 1975, it was never removed from the list. (22, 31)

Still, Orange B is approved under tight restrictions. Its use is limited to casings of hot dog and sausage casings only, and it must not exceed 150 parts per million (ppm) by weight of the finished food. (31)

Natural and Safer Alternatives to Orange B Food Dye

For those seeking safer alternatives, natural food colorings offer a viable option. Ingredients such as turmeric, paprika, and beta-carotene can provide vibrant yellow-to-orange colors without the associated health risks of synthetic dyes. In addition to enhancing the visual appeal of food products, these natural dye alternatives offer nutritional benefits, making them a preferable choice for health-conscious consumers.

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Key Takeaways:

• Orange B is one of nine artificial food dyes approved for use in food products in the United States. Limiting exposure is beneficial because of the health risks associated with Orange B food dye. 
• The United States FDA has restricted its use to the casings of hot dogs and sausages, and it is no longer manufactured in the United States, significantly reducing dietary exposure. 
• Reading food labels, removing casings from meat products containing the dye, and using natural food dye alternatives at home are excellent ways to reduce exposure to Orange B and its carcinogenic potential.