Nutrient Fact Sheets
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August 29, 2024

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

Written By
Dr. Jaime Cloyd ND
Medically Reviewed by
Updated On
January 14, 2025

Food dyes are commonly used in the modern food industry to make food look more appealing. A 2016 study found that over 90% of candies, fruit-flavored snacks, and drink mixes contain synthetic dyes.

The Food and Drug Administration (FDA) oversees the use of food additives and dyes in consumer products in the United States. Synthetic dyes must be produced according to the guidelines 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.

There is growing awareness of potential health concerns related to food dyes, especially since California's Office of Environmental Health Hazard Assessment (OEHHA) released a report in 2020 suggesting that food dye consumption may affect neurobehavioral outcomes in children. This article will explore the safety and potential risks associated with Orange B food dye, offering an 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 widely used, making up about 70% of all artificial dyes. They are known for having an azo group (a nitrogen double bond, –N=N–) in their chemical structure.

Chemical Composition

Orange B is the disodium salt of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-sulfonaphthylazo)-5-hydroxypyrazole. It consists of two benzene rings connected by an azo group, with sulfonate groups 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. Its approved uses are limited to hot dog and sausage casings, and it cannot exceed 150 parts per million (ppm) by weight of the finished food. It is not approved for use in cosmetics or medications.

Risks Associated with Orange B Food Dye

The safety of Orange B food dye has been debated. Various studies, mainly in animal models, suggest potential health concerns related to its consumption.

It highlights various health risks linked to this food colorant. It mentions hyperactivity in children, cancer, and allergies as potential concerns.

Potential Health Risks

Common health concerns associated with food dyes include:

Synthetic food dyes may contribute to or worsen hyperactive behavior in children. This concern gained attention after the 1975 Feingold Diet suggested that removing artificial food colorings and certain additives from children's diets could help manage hyperactivity symptoms.

In 2020, California's OEHHA released a report suggesting that synthetic food dyes could impact neurobehavioral outcomes in children, highlighting the need for further research and potential regulatory review. The FDA reviewed the evidence and concluded that while there may be a link between certain food dyes and hyperactivity in some children, the evidence is not strong enough to require regulatory action.

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

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 affecting fetal development.
  • The elderly may be more affected due to weakened physiological systems and a reduced capacity to manage harmful substances.
  • Individuals with preexisting atopic diseases, such as asthma, eczema, or allergies, are at increased risk because their immune systems may be more sensitive, making them more susceptible to exacerbated symptoms and new sensitivities.

Causes and Symptoms of Adverse Reactions

Adverse reactions to Orange B food dye may occur due to its interaction with the body's metabolic processes.

Mechanisms of Adverse Reactions

When ingested, 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, which may contribute 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 more noticeable effects.

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 be associated with more serious health issues, including:

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.

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.

Natural and Safer Alternatives to Orange B Food Dye

For those seeking alternatives, natural food colorings may offer a viable option. Ingredients such as turmeric, paprika, and beta-carotene can provide vibrant yellow-to-orange colors. In addition to enhancing the visual appeal of food products, these natural dye alternatives may 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 may be beneficial due to the potential 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 ways to reduce exposure to Orange B and its potential risks.
The information in this article is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. This information should not be used to diagnose or treat any health problems or illnesses without consulting a doctor. Consult with a health care practitioner before relying on any information in this article or on this website.

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