fdc colors
fdc colors

FD&C Colors

Common names: FD&C Blue No. 1 (Brilliant Blue FCF or E133), FD&C Blue No. 2 (Indigotine or E132), FD&C Green No. 3 (Fast Green FCF or E143), FD&C Red No. 3 (Erythrosine or E127), FD&C Yellow No. 5 (Tartrazine or E102).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
FD&C colors are synthetic dyes approved by the U.S. Food and Drug Administration (FDA) for use in foods, drugs, and cosmetics.[1]
They are utilized to enhance the visual appeal of products, providing consistent and vibrant colors that attract consumers.[1] Common examples include FD&C Yellow No. 5 (Tartrazine) and FD&C Blue No. 1 (Brilliant Blue FCF).[1]
Despite their widespread use, concerns have been raised regarding the safety of certain FD&C colors.[2] For instance, in January 2025, the FDA banned the use of FD&C Red No. 3 in foods and ingested drugs due to studies linking it to cancer in laboratory animals.[2] While other FD&C colors remain approved, ongoing evaluations ensure that their use continues to meet safety standards.[2]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration (FDA) regulates FD&C color additives, requiring certification for each batch to ensure safety and compliance with specifications.[1] However, in January 2025, the FDA banned the use of FD&C Red No. 3 in foods and ingested drugs due to studies linking it to cancer in laboratory animals.[2]
Health Canada
Health Canada regulates food additives, including colorants, ensuring they meet safety standards before approval.[3] In 2025, Health Canada stated that erythrosine “does not pose a health risk to the general Canadian population at the levels set out in the List of Permitted Food Colours.”[3]
EFSA (Europe)
The European Food Safety Authority (EFSA) evaluates and authorizes food additives, including colors, within the European Union.[4] For instance, EFSA has assessed erythrosine (E127) and permits its use in specific food products under established maximum levels, considering current scientific evidence.[4]
WHO (World Health Organization)
The World Health Organization (WHO), through the Joint FAO/WHO Expert Committee on Food Additives (JECFA), assesses the safety of food additives globally.[5] JECFA has evaluated various color additives, including erythrosine, and established acceptable daily intake (ADI) levels based on available toxicological data.[5]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
The U.S. Food and Drug Administration (FDA) does not recognize any color additives, including FD&C colors, as Generally Recognized as Safe (GRAS); instead, all color additives must undergo a rigorous premarket approval process to ensure their safety for specific uses.[6]

EWG Rating

Environmental Working Group
  • EWG Rating: The Environmental Working Group (EWG) assigns FD&C colors, such as FD&C Red No. 3, a high concern rating due to potential health risks.[7]
  • Level of Caution: EWG advises consumers to exercise caution when encountering FD&C colors in products, highlighting associations with adverse neurobehavioral outcomes in children.[8]
  • Possible Health Risks: Studies have linked synthetic food dyes, including FD&C colors, to behavioral issues in children, prompting recommendations for reduced exposure.[8]
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More about FD&C Colors

  • Candies and Gummies: Skittles (FD&C Yellow No. 5, FD&C Red No. 40), Sour Patch Kids (FD&C Blue No. 1, FD&C Yellow No. 5), M&M's (FD&C Red No. 40, FD&C Yellow No. 5).
  • Carbonated Beverages: Mountain Dew (FD&C Yellow No. 5), Fanta Orange (FD&C Yellow No. 6), Pepsi Blue (FD&C Blue No. 1).
  • Packaged or Canned Fruits and Vegetables: Del Monte Fruit Cocktail (FD&C Red No. 3), Dole Cherry Mixed Fruit (FD&C Red No. 40), Libby’s Canned Cherries (FD&C Red No. 3).

Historical Use
FD&C colors, synthetic dyes approved by the U.S. Food and Drug Administration (FDA), have been utilized since the early 20th century to enhance the visual appeal of various consumer products, including foods, beverages, cosmetics, and pharmaceuticals.[1] Their application aimed to provide consistent and appealing colors that attract consumers.[1]
Current Exposure
Today, consumers are frequently exposed to FD&C colors through a wide array of products.[9] These synthetic dyes are commonly found in items such as candies, soft drinks, baked goods, and processed foods, contributing to their vibrant and uniform appearance.[9]
Banned FD&C Colors in the U.S.
Over the years, several FD&C colors have been banned in the U.S. due to health concerns, particularly their links to toxicity and cancer risks in animal studies. These bans were implemented after scientific studies indicated potential harm. Below is a summary of the banned FD&C colors and their associated risks:
  • FD&C Orange No. 1 (1956) - Caused allergic reactions and liver toxicity in children, including a notable Halloween candy incident.[14]- sodium salt (1
    • 1)" link="https://pubchem.ncbi.nlm.nih.gov/compound/135513128#section=General-Manufacturing-Information"]

    Carcinogenicity
    The U.S. Food and Drug Administration (FDA) has banned the use of FD&C Red No. 3 in foods and ingested drugs due to studies indicating a potential cancer risk, particularly thyroid tumors observed in laboratory rats.[20]
    Neurobehavioral Effects
    Research, including a comprehensive assessment by the California Office of Environmental Health Hazard Assessment (OEHHA), has linked synthetic food dyes to hyperactivity and other neurobehavioral issues in children, suggesting that certain individuals may be more susceptible to these effects.[21]
    Allergic Reactions
    Some FD&C colors, such as Yellow No. 5 (Tartrazine), have been associated with allergic responses, including hives and asthma symptoms, particularly in sensitive individuals.[22]
    Genotoxicity
    Studies have raised concerns about the genotoxic potential of certain synthetic food dyes, indicating they may cause damage to genetic material, though further research is needed to fully understand these risks.[23]

    Toxicological Studies
    Research indicates that certain FD&C colors, such as Red No. 3, have been associated with carcinogenic effects in animal studies, leading to regulatory actions like the FDA's ban on its use in foods and ingested drugs.[20]
    Long-Term Safety
    The long-term safety of FD&C colors remains a subject of ongoing research, with some studies suggesting potential health risks, including carcinogenicity and behavioral effects, necessitating further investigation to fully understand their implications.[23]

    High-Risk Groups
    Children are particularly vulnerable to the effects of synthetic food dyes, including FD&C colors, due to their developing neurological systems and higher consumption rates relative to body weight.[24] Studies have indicated that certain artificial colorants may exacerbate hyperactive behaviors in children, especially those with Attention Deficit Hyperactivity Disorder (ADHD).[24]
    Health Impacts
    Research has shown that exposure to synthetic food dyes can lead to adverse neurobehavioral outcomes in sensitive populations.[21] For instance, a comprehensive assessment by the California Office of Environmental Health Hazard Assessment (OEHHA) found evidence linking these dyes to increased hyperactivity and attention deficits in children.[21]

    Recommended Intake
    Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), have established Acceptable Daily Intake (ADI) levels for FD&C colors to ensure consumer safety.[25] For example, the ADI for FD&C Red No. 40 is set at 7 mg per kg of body weight per day, while FD&C Yellow No. 6 has an ADI of 3.75 mg per kg of body weight per day.[25] These ADIs represent the maximum amount considered safe to consume daily over a lifetime without appreciable health risk.[25]

    General Safety Level
    FD&C color additives are generally considered safe for the majority of the population when used within established regulatory limits.[26] However, certain dyes, such as FD&C Yellow No. 5 (Tartrazine), have been associated with adverse reactions, including urticaria and angioedema, in sensitive individuals.[26]
    Sensitive Individuals
    A small subset of the population may experience hypersensitivity reactions to specific FD&C colors.[27] For instance, FD&C Yellow No. 5 has been linked to allergic-type responses, such as hives, in fewer than 1 in 10,000 people.[27]

    FAQ

    What are FD&C colors?

    FD&C colors are synthetic dyes approved by the U.S. FDA for use in food, drugs, and cosmetics.

    What does FD&C colors mean?

    FD&C stands for 'Food, Drug, and Cosmetic,' indicating that these colors are certified for use in these products.

    What is FD&C colors?

    FD&C colors are artificial color additives regulated by the FDA for safety in food, drugs, and cosmetics.

    Where to buy FD&C colors?

    FD&C colors can be purchased from specialty ingredient suppliers, online marketplaces, and food additive distributors.

    References

    1. FDA Color Additives in Foods Available at: https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods ↩︎
    2. FDA FD&C Red No. 3 Available at: https://www.fda.gov/industry/color-additives/fdc-red-no-3 ↩︎
    3. Health Canada List of Permitted Food Colours Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html ↩︎
    4. EFSA 2015 Update of the Scientific Opinion on the safety and efficacy of erythrosine in feed for cats dogs reptiles and ornamental fish EFSA Journal Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4233 ↩︎
    5. JECFA Erythrosine Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3740 ↩︎
    6. FDA Determining the Regulatory Status of a Food Ingredient Available at: https://www.fda.gov/food/food-ingredients-packaging/determining-regulatory-status-food-ingredient ↩︎
    7. Environmental Working Group FD&C Red No. 3 Available at: https://www.ewg.org/cleaners/substances/8214-FDCREDNO3/ ↩︎
    8. Environmental Working Group EWGs Guide to Food Additives Available at: https://static.ewg.org/pdf/EWG_TipSheet-FoodAdditives_C02.pdf ↩︎
    9. FitCoding Understanding FD&C Colors A Comprehensive Overview Available at: https://fitcoding.com/understanding-fdc-colors-a-comprehensive-overview ↩︎
    10. US Food and Drug Administration FDA n.d. Regulatory Status of Color Additives FD&C Red No. 2 Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives&id=FDCRed2 ↩︎
    11. US Food and Drug Administration FDA n.d. Regulatory Status of Color Additives FD&C Red No. 3 Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives&id=FDCRed3&sort ↩︎
    12. US Food and Drug Administration FDA n.d. Regulatory Status of Color Additives FD&C Red No. 4 Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives&id=FDCRed4 ↩︎
    13. National Center for Biotechnology Information NCBI n.d. Benzenesulfonic acid 4-[2-(4-hydroxy-1-naphthalenyl)diazenyl]- sodium salt (1:1) Available at: https://pubchem.ncbi.nlm.nih.gov/compound/135513128#section=General-Manufacturing-Information ↩︎
    14. National Center for Biotechnology Information NCBI n.d. C.I. Solvent Orange 2 Available at: https://pubchem.ncbi.nlm.nih.gov/compound/C.I.-Solvent-Orange-2 ↩︎
    15. US Food and Drug Administration FDA n.d. 21 CFR u00a7 81.10 Termination of provisional listings of color additives Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-81/section-81.10 ↩︎
    16. World Health Organization WHO n.d. Yellow 2G Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3225 ↩︎
    17. World Health Organization WHO n.d. CI Food Yellow 3 Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/476 ↩︎
    18. US Food and Drug Administration FDA n.d. 21 CFR u00a7 81.10 Termination of provisional listings of color additives Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-81/section-81.10 ↩︎
    19. Associated Press FDA bans red dye No. 3 from foods Available at: https://apnews.com/article/94c3e418584fb1e91ca3b0cbeb3d5a60 ↩︎
    20. California Office of Environmental Health Hazard Assessment Health Effects Assessment Potential Neurobehavioral Effects of Synthetic Food Dyes in Children Available at: https://oehha.ca.gov/media/downloads/risk-assessment/report/healthefftsassess041621.pdf ↩︎
    21. Healthline FD&C Yellow 5 What It Is Health Effects Cancer Risk and More Available at: https://www.healthline.com/health/yellow-5 ↩︎
    22. Center for Science in the Public Interest Food Dyes A Rainbow of Risks Available at: https://www.cspinet.org/sites/default/files/attachment/food-dyes-rainbow-of-risks.pdf ↩︎
    23. Stevenson DD Simon RA 1981 Adverse Reactions to Tartrazine Journal of Asthma 18(1) 25-29 Available at: https://ehjournal.biomedcentral.com/articles/10.1186/s12940-022-00849-9 ↩︎
    24. Centers for Disease Control and Prevention Determination of Red Food Coloring in Commercial Beverages Available at: https://stacks.cdc.gov/view/cdc/58356/cdc_58356_DS8.pdf ↩︎
    25. FD&C Yellow 6 Hypersensitivity Unveiled in a Patient Treated with Annals of Allergy Asthma & Immunology Available at: https://www.annallergy.org/article/S1081-1206%2822%2901470-3/fulltext ↩︎
    26. Lockey SD 1959 Allergic reactions due to FD&C Yellow No. 5 tartrazine an aniline dye used as a coloring and identifying agent in various steroids Annals of Allergy 17(10) 719-721 Available at: https://www.annallergy.org/article/S1081-1206(10)61010-1/abstract ↩︎

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