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Is food coloring bad for you?

Medically reviewed by Sally Chao, MD. Last updated on Sep 1, 2021.

Official answer

by Drugs.com

In the United States, food colorings, or color additives, are considered generally safe and not bad for you if they are approved by the Food and Drug Administration (FDA), the department that regulates food dyes.

There are some long-standing questions about specific health and safety effects of certain food dyes, but the FDA maintains that its regulatory process ensures there is “reasonable certainty of no harm” for the approved color additives. At the same time, experts at the FDA note that absolute safety of any substance is not always possible to ascertain given the limitations of research and scientific understanding.

In general, the primary health concerns that have been questioned with certain food dyes are an increased risk of cancer, allergic reactions and behavioral problems such as hyperactivity among children. Some dyes have been implicated with health concerns more than others.

  • In terms of hyperactivity concerns, California’s Environmental Protection Agency published a report in August of 2020 stating that certain children exposed to synthetic food dyes may be more likely to show signs of behavioral problems, including inattentiveness, hyperactivity and restlessness. According to the report, Red No. 3, Red No. 40 and Yellow No. 5 showed the strongest associations with behavioral effects in children, as compared to other artificial dyes.
  • One example of the cancer concerns linked to food dyes stems from a small study performed on rats in 1990. The study found that rats exposed to high levels of Red No. 3 faced a significantly increased risk of developing tumors in their thyroid, resulting in the FDA limiting the use of Red No. 3 in certain food products. However, the FDA’s analysis of the data concluded that the risk of getting cancer related to lifelong consumption of Red No. 3 is less than 1 in 100,000.
  • Allergic reactions to food dyes are often discussed in relation to Yellow No. 5. The FDA states that a small portion of people may experience an allergic response to Yellow No. 5 and develop itchiness and hives after exposure. These reactions are considered rare and tend to occur among people who have asthma or are prone to hives.

Since 1927 when the FDA began regulating the safety of color additives, many color additives have been banned. Today, the FDA regulates:

  • The amount of food dye that can be used in a product
  • How products must label food dye ingredients
  • Which products food dyes can be added to

When contaminated or otherwise harmful batches of food dyes are discovered, the government can stop the facility from making the product or impose other restrictions.

When approving a new color additive, the FDA analyzes factors like:

  • The potential long- and short-term health consequences of exposure to the additive
  • The substances or chemicals that make up the additive
  • How it is manufactured
  • At what levels it can be safely added to foods

Approved color additives

Currently, there are 9 certified color additives approved by the FDA. Certified color additives are artificially made dyes that must be batch tested. This means that manufacturers are required to send the FDA a sample of the product, which is analyzed to ensure the dye’s quality and safety in accordance with its approval.

Although the FDA has determined these dyes to be safe, there are some studies, largely in animals and laboratories, that suggest otherwise. Some dyes come with more potential safety concerns than others. Below are the 9 certified color additives in the United States, and some of their potential health impacts, as proposed by various studies:

FD&C Blue No. 1 (approved for use in drinks, confections, cereals, frozen desserts and frostings/icings)

  • There is some evidence that Blue No. 1 could cause hypersensitivity (allergic reactions) in rare cases.
  • In 2003, the FDA released a report regarding the use of Blue No. 1 in nutritional solutions given to patients receiving nutrients through an enteral feeding tube. Enteral feeding tubes deliver nutrients through a tube in the stomach or throat to hospitalized patients who are malnourished or unable to eat normally. Blue No. 1 may sometimes be added to the feeding tube solutions to help doctors detect if the nutrients accidentally enter the windpipe instead of going down to the stomach. The FDA found reports of serious and life-threatening outcomes related to enteral feeding solutions containing Blue No. 1, although it was not established whether the dye was directly causing the adverse outcomes.

FD&C Blue No. 2 (approved for use in baked goods, snacks, cereals, ice cream, yogurt and confections)

  • Some studies suggest that Blue No. 2 may have toxic effects. In animal studies, Blue. No. 2 has been linked to DNA damage and cancer.

FD&C Green No. 3 (approved for use in cereals, sherbet, ice cream, drink mixers and baked goods)

  • Green 3 is hardly ever used in food products in the U.S. Instead, the green color is typically achieved by mixing blue and yellow dyes.
  • Some studies performed on rats showed that Green No. 3 decreased hemoglobin levels (the protein that carries oxygen in the bloodstream).

Orange B (only approved for use in hot dog and sausage casings)

  • Orange B is hardly ever used in food products in the U.S. The FDA has not certified a new batch of Orange B since 1975. However, some studies assert that it contains a contaminant that is potentially associated with cancer.

Citrus Red No. 2 (only approved to color orange peels)

  • Citrus Red No. 2 is not a large health concern, as it can only be used to color orange peels in the U.S. An older study in rats linked Citrus Red No. 2 with cancer, but the FDA conducted two larger studies in rats and mice that found no such association. However, various laboratory studies have suggested that long-term exposure to the dye has the potential to promote cancer, damage to DNA (genes) and nervous system problems.

FD&C Red No. 3 (approved for use in drinks, cereals, ice cream cones, frozen desserts, frostings/icings and confections)

  • In 1990, a small study found that rats exposed to high levels of Red No. 3 faced a significantly increased risk of developing thyroid tumors, leading the FDA to ban the use of Red No. 3 in certain food products. However, the dye is still being used today. According to the FDA, the risk of getting cancer associated with high consumption of Red No. 3 over the course of one’s lifetime is less than 1 in 100,000.
  • In a report published in August of 2020, California’s Environmental Protection Agency found that certain children exposed to synthetic food dyes may be more likely to exhibit behavioral problems, including inattentiveness, hyperactivity and restlessness. Red No. 3 (along with Red No. 40 and Yellow No. 5) showed the strongest associations with behavioral effects in children, compared to other artificial dyes.

FD&C Red No. 40 (approved for use in drinks, gelatins/puddings, dairy products, cereals and confections)

  • In a report published in August of 2020, California’s Environmental Protection Agency found that certain children exposed to synthetic food dyes may be more likely to show signs of behavioral problems, including inattentiveness, hyperactivity and restlessness. Red No. 40 (along with Red No. 3 and Yellow No. 5) showed the strongest associations with behavioral effects in children, compared to other artificial dyes.
  • Red No. 40, as well as Yellow No. 5 and Yellow No. 6, contain a cancer-causing chemical called benzidine. The levels of benzidine in these dyes are considered low enough to pose little risk. However, some studies suggest that these dyes expose people to more benzidine than is safe.

FD&C Yellow No. 5 (approved for use in cereals, snacks, drinks, confections, condiments, yogurt and baked goods)

  • Yellow No. 5, as well as Red No. 40 and Yellow No. 6, contain a cancer-causing chemical called benzidine. The levels of benzidine in these dyes are considered low enough to pose little risk. However, some studies suggest that these dyes expose people to more benzidine than is safe.
  • In a report published in August of 2020, California’s Environmental Protection Agency found that certain children exposed to synthetic food dyes may be more likely to show signs of behavioral problems, including inattentiveness, hyperactivity, and restlessness. Yellow No. 5 (along with Red No. 3 and Red No. 40) showed the strongest associations with behavioral effects in children, compared to other artificial dyes.
  • According to the FDA, some individuals may be allergic to Yellow No. 5 and experience itching and hives after consuming food products that contain the dye. However, these allergic reactions are considered very rare and are said to occur mainly among young children who are particularly sensitive to the dye. The incidence of hives related to Yellow No. 5 is estimated to occur in less than one out of 10,000 people. These types of reactions seem to occur mostly in individuals who have asthma or are prone to hives.

FD&C Yellow No. 6 or tartrazine (approved for use in snacks, cereals, baked goods, gelatins, drinks, dessert powders, crackers and sauces)

  • Yellow No. 6, as well as Yellow No. 5 and Red No. 40, contain a cancer-causing chemical called benzidine. The levels of benzidine in these dyes are considered low enough to pose little risk. However, some studies suggest that these dyes expose people to more benzidine than is safe.
References
  1. U.S. Food and Drug Administration (FDA). How Safe are Color Additives? August 2021. Available at: https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives. [Accessed August 9, 2021].
  2. Soares BM, Araújo TM, Ramos JA, et al. Effects on DNA repair in human lymphocytes exposed to the food dye tartrazine yellow. Anticancer Res. 2015;35(3):1465-1474. https://pubmed.ncbi.nlm.nih.gov/25750299/.
  3. California Office of Environmental Health Hazard Assessment. Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children [Draft]. 2020. https://oehha.ca.gov/media/downloads/risk-assessment/report/fooddyesassessmentdraft082820.pdf. [Accessed August 9, 2021].
  4. Burrows, JD. Palette of Our Palates: A Brief History of Food Coloring and Its Regulation. Comprehensive Reviews in Food Science and Food Safety, 2009;8: 394-408. https://doi.org/10.1111/j.1541-4337.2009.00089.x.
  5. U.S. Food and Drug Administration (FDA). Overview of Food Ingredients, Additives & Colors. April 2010. Available at: https://www.fda.gov/food/food-ingredients-packaging/overview-food-ingredients-additives-colors. [Accessed August 9, 2021].
  6. Elhkim MO, Héraud F, Bemrah N, et al. New considerations regarding the risk assessment on Tartrazine: An updated toxicological assessment, intolerance reactions and maximum theoretical daily intake in France. Regul Toxicol Pharmacol. 2007;47(3):308-316. https://doi.org/10.1016/j.yrtph.2006.11.004.
  7. U.S. Food and Drug Administration (FDA). Color Additives History. November 2003. Available at: https://www.fda.gov/industry/color-additives/color-additives-history. [Accessed August 9, 2021].
  8. U.S. Food and Drug Administration (FDA). Color Additives Questions and Answers for Consumers. January 2018. Available at: https://www.fda.gov/food/food-additives-petitions/color-additives-questions-and-answers-consumers. [Accessed August 9, 2021].
  9. Kobylewski S, Jacobson MF. Toxicology of food dyes. Int J Occup Environ Health. 2012;18(3):220-246. https://doi.org/10.1179/1077352512Z.00000000034.
  10. U.S. Food and Drug Administration (FDA). FDA Public Health Advisory: Subject: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C Blue No. 1. September 2003. Available at: https://www.fda.gov/industry/medical-devices/fda-public-health-advisory-subject-reports-blue-discoloration-and-death-patients-receiving-enteral. [Accessed August 9, 2021].
  11. Okafor S, Obonga W, Ezeokonkwo M. Assessment of the Health implications of Synthetic and Natural Food Colourants – A Critical Review. UK Journal of Pharmaceutical Biosciences. 2016. DOI:10.20510/ukjpb/4/i4/110639.
  12. Lehto S, Buchweitz M, Klimm A, et al. Comparison of food colour regulations in the EU and the US: a review of current provisions [published correction appears in Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2017 May;34(5):882]. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2017;34(3):335-355. https://doi.org/10.1080/19440049.2016.1274431.
  13. Ali M, Hassan A, Hassanien M. . Effect of Food Colorants and Additives on the Hematological and Histological Characteristics of Albino Rats. Toxicology and Environmental Health Sciences. 2019;11:155-167. https://doi.org/10.1007/s13530-019-0400-x.
  14. Potera C. The artificial food dye blues. Environ Health Perspect. 2010;118(10):A428. https://doi.org/10.1289/ehp.118-a428.

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