FDC Blue No 2
FDC Blue No 2

FDC blue no 2

Common names: CI Food Blue 2, Indigotine, Indigo Carmine, Brillant Indigotine (brand name), E132 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 1, 2025
Medically reviewed by Dr. William Lin, MD
FD&C Blue No. 2, also known as indigotine or indigo carmine, is a synthetic dye widely utilized in the food industry to impart a blue hue to products such as candies, beverages, cereals, and baked goods.[1] Its vibrant color and stability make it a popular choice for enhancing the visual appeal of various consumables.[1] Additionally, it is employed in pharmaceuticals and cosmetics for coloring purposes.[1]
Despite its widespread use, concerns have been raised regarding potential health effects associated with FD&C Blue No. 2.[2]
Some animal studies have suggested a possible link to brain tumors in high-dose groups, though these findings are not conclusive.[2] Regulatory agencies, including the U.S. Food and Drug Administration (FDA), have evaluated the evidence and continue to permit its use within specified limits, indicating a consensus of safety when used appropriately.[3]

Safety Overview

Regulatory Bodies

FDA (US)
The FDA has approved FD&C Blue No. 2 for use in foods, drugs, and cosmetics, specifying permissible types of products and maximum usage levels to ensure consumer safety.[4]
Health Canada
Health Canada’s List of Permitted Colouring Agents includes Indigo Carmine, allowing its use in various food products within specified limits.[5]
EFSA (Europe)
EFSA has evaluated Indigo Carmine (E132) and determined that it is poorly absorbed in the gastrointestinal tract, with no significant safety concerns at current exposure levels.[6]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives has assessed Indigo Carmine and found no safety concerns for its use as a food additive.[7]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
FD&C Blue No. 2 is not classified as GRAS (Generally Recognized as Safe) by the U.S. Food and Drug Administration (FDA). Instead, it is an approved color additive that is subject to regulatory oversight, meaning it must comply with specified conditions of use in food, drugs, and cosmetics.[4]

EWG Rating

Environmental Working Group
  • EWG Rating: The EWG assigns FD&C Blue No. 2 a moderate concern rating in food products.[8]
  • Level of Caution: This rating suggests that consumers should be moderately cautious about products containing this artificial colorant.[8]
  • Possible Health Risks: Studies have indicated potential links between FD&C Blue No. 2 and adverse effects, such as hyperactivity in children and tumor formation in animal studies.[9]
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More about FDC blue no 2

  • Confectionery: Hard candies, Chewing gum, Gummy snacks
  • Beverages: Sports drinks, Carbonated sodas, Flavored water
  • Processed Foods: Breakfast cereals, Ice cream, Gelatin desserts

Historical Use
FD&C Blue No. 2, also known as Indigotine or Indigo Carmine, is a synthetic dye derived from indigo, a natural dye historically used for coloring textiles. In the early 20th century, the U.S. Food and Drug Administration (FDA) approved Indigotine as one of the original seven synthetic color additives for use in foods, drugs, and cosmetics. By 1931, it was among the 15 straight colors approved for such applications.[10]
Current Exposure
Today, consumers encounter FD&C Blue No. 2 in a variety of products, including baked goods, cereals, snack foods, ice cream, confections, and yogurt. Its widespread use in the food industry is due to its vibrant blue hue and stability, enhancing the visual appeal of numerous consumables. Additionally, it is employed in pharmaceuticals and cosmetics for coloring purposes.[2][11]

Neurobehavioral Effects
Studies have indicated that synthetic food dyes, including FD&C Blue No. 2, may exacerbate hyperactivity and other behavioral issues in children, particularly those with attention-deficit/hyperactivity disorder (ADHD).[12]
Carcinogenic Potential
Animal studies have reported an increased incidence of brain tumors in rats exposed to high doses of FD&C Blue No. 2, though these findings have not been conclusively linked to human cancer risk.[13]
Allergic Reactions
Some individuals may experience hypersensitivity reactions, such as skin irritation or anaphylaxis, following exposure to FD&C Blue No. 2, especially when used in medical procedures.[14]
Gastrointestinal Disturbances
Ingestion of FD&C Blue No. 2 has been associated with gastrointestinal symptoms, including nausea, vomiting, and diarrhea, in certain sensitive individuals.[15]

Toxicological Studies
Research indicates that FD&C Blue No. 2 has a no-observed-adverse-effect level (NOAEL) of 250 mg/kg body weight per day in rats and rabbits [6]. However, some animal studies have reported an increased incidence of brain tumors in male rats at high doses, though these findings are not conclusive regarding human health risks.[2][15]
Long-Term Safety
Long-term studies, including a 30-month investigation in rats, have not consistently demonstrated adverse effects associated with FD&C Blue No. 2 consumption.[16] Nonetheless, due to observed tumor development in certain animal studies, concerns about its long-term safety persist, warranting further research.[16]

High-Risk Groups
Individuals with pre-existing renal conditions may be at increased risk when exposed to FD&C Blue No. 2 (Indigo Carmine). For instance, during surgical procedures, the use of Indigo Carmine has been associated with absent ureteral spill in patients with previously undiagnosed renal disease, indicating potential complications in this population.[17]
Health Impacts
While FD&C Blue No. 2 is generally considered safe for the general population, its use in medical settings has revealed potential adverse effects in vulnerable individuals. Specifically, patients with compromised renal function may experience complications such as absent ureteral spill during procedures involving Indigo Carmine, underscoring the need for cautious use in these groups.[17]

Recommended Intake
Regulatory bodies have established an Acceptable Daily Intake (ADI) for FD&C Blue No. 2 at 5 mg per kilogram of body weight per day.[5][6]

General Safety Level
FD&C Blue No. 2, also known as Indigo Carmine, is widely used as a food colorant and is generally considered safe for the majority of the population.[15] However, some studies have raised concerns about potential toxic effects, suggesting the need for further research.[2]
Sensitive Individuals
Although rare, certain individuals may experience hypersensitivity reactions to synthetic dyes, including FD&C Blue No. 2[14] These reactions can manifest as skin irritation, respiratory issues, or other allergy-like symptoms.[14]

References

  1. Marmion DM 1991 Handbook of US Colorants Foods Drugs Cosmetics and Medical Devices Wiley-Interscience ↩︎
  2. Center for Science in the Public Interest 2010 Food Dyes A Rainbow of Risks Available at: https://www.cspinet.org/resource/food-dyes-rainbow-risks ↩︎
  3. US Food and Drug Administration 2021 Color Additives in Foods Available at: https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods ↩︎
  4. US Food and Drug Administration n.d. Code of Federal Regulations 21 - F&DC Blue No. 2 Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-A/section-74.102 ↩︎
  5. Health Canada 2024 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 ↩︎
  6. European Food Safety Authority 2014 Scientific Opinion on the re-evaluation of Indigo Carmine E 132 as a food additive EFSA Journal 12(7) 3768 Available at: https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2014.3768 ↩︎
  7. World Health Organization 2018 FD and C Blue No. 2 Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/113 ↩︎
  8. Environmental Working Group n.d. Artificial Color Blue 2 Available at: https://www.ewg.org/foodscores/ingredients/7554-ArtificialColorBlue2/ ↩︎
  9. Environmental Working Group n.d. FD&C Blue 2 Aluminum Lake Available at: https://www.ewg.org/skindeep/ingredients/702411-FDC_BLUE_2_ALUMINUM_LAKE/ ↩︎
  10. US Food and Drug Administration n.d. Color Additives History Available at: https://www.fda.gov/industry/color-additives/color-additives-history ↩︎
  11. US Food and Drug Administration 2023 Color Additives Questions and Answers for Consumers Available at: https://www.fda.gov/food/color-additives-information-consumers/color-additives-questions-and-answers-consumers ↩︎
  12. Miller MD et al. 2022 Potential impacts of synthetic food dyes on activity and attention in children a review of the human and animal evidence Global Pediatric Health 9 2333794X221089455 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9052604/ ↩︎
  13. Kobylewski S Jacobson MF 2012 Toxicology of food dyes International Journal of Occupational and Environmental Health 18(3) 220-246 Available at: https://pubmed.ncbi.nlm.nih.gov/23026007/ ↩︎
  14. Swerlick RA Campbell CF 2013 Medication dyes as a source of drug allergy Journal of Allergy and Clinical Immunology In Practice 1(5) 526-528 Available at: https://pubmed.ncbi.nlm.nih.gov/23377335/ ↩︎
  15. Ristea ME Zarnescu O 2023 Indigo Carmine Between Necessity and Concern Medicina 59(8) 1400 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10532910/ ↩︎
  16. Borzelleca JF Depukat K Hallagan JB 1985 Chronic toxicity/carcinogenicity study of FD & C Blue No. 2 in rats Food and Chemical Toxicology 23(6) 551-558 Available at: https://pubmed.ncbi.nlm.nih.gov/4040101/ ↩︎
  17. Jelovsek JE et al. 2007 Incidence of Lower Urinary Tract Injury at the Time of Total Laparoscopic Hysterectomy Journal of the Society of Laparoscopic & Robotic Surgeons 11(4) 422-427 Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC3015849/ ↩︎

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