A Regulatory Perspective on the U.S. Food & Drug Administration Approval and Subsequent Ban of FD&C Red No. 3 as a Colorant

By Julie Holt, Director, Global Advisory Services

Introduction

The United States Food & Drug Administration (FDA) approved FD&C Red No. 3, a petroleum-based food dye, for use in foods in 1969. Synthetic food dyes add a burst of color to many food and beverage products including beverages, cereals, confectionery, pastry, and condiments. Unfortunately, some dyes such as FD&C Red No. 3 are now linked to negative health outcomes such as behavioral disorders and even cancer. Red No. 3 has been used by the United States food and beverage industry for over 30 years. It has no nutritional value and is used solely to impart color¹.

The post-market assessment of chemicals, including colorants, in food is a significant priority for the United States Food & Drug Administration. This post-market responsibility includes an ongoing review of many additive categories. Although evidence shows Red No. 3 is not harmful to humans, the FDA was obligated to ban the colorant in foods and ingestible drugs in part due to a legal technicality. All additives, including colorants, must be approved for use by the FDA to be used in food and drugs sold in the United States.

Navigating evolving food additive regulations like the ban on Red Dye 3 can be complex, especially if you don’t have the right tools.

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Federal oversight of colorants in the U. S. began in the 1880s.

In 1906, Congress passed the Food and Drugs Act which prevented the use of poisonous or deleterious colors in confectionery and in food to conceal inferiority. In 1927, responsibility for enforcing the Food and Drugs Act was given to the newly formed Food and Drug Administration. By 1915, fifteen colorants were approved for use in food. FDA has approved 36 color additives, 9 of which are synthetic dyes including both Red Dye No. 3 and Red Dye No. 40².

On January 15, 2025, the U.S. FDA banned the use of Red No. 3 in foods, beverages and ingested drugs, more than three decades after the agency prohibited its use in cosmetics due to potential cancer risks³. This move came as California is poised to ban the use of synthetic food dyes in schools and as newly appointed Human Health and Services Secretary Robert F. Kennedy Jr. pushes for a nationwide ban on artificial dyes. Red Dye No 3 already is banned for sale, distribution, and manufacturing by the State of California beginning in 2027⁴.

In 2021, the California Environmental Protection Agency reviewed the existing research on synthetic dyes and found that they could negatively impact children’s behavior in terms of inattention and hyperactivity. While several other states including Illinois and Washington have proposed similar legislation to ban synthetic food dyes, there are also petitions seeking to expand the ban on certain colorants nationwide. More recently, states including Utah and Illinois are taking a closer look at many food additives, including colorants⁵.

FD&C Red No. 3 has a long history of use and review.

In 1990, the FDA banned Red Dye No. 3 from being used in cosmetics and topical drugs after a study found that it caused cancer in male rats. For many years, consumers, health advocates, and NGOs (non-governmental organizations) pushed the agency to take similar action for foods since federal rules require the agency to prohibit the use of additives that have been shown to cause cancer in animals or humans. This legislation is commonly known as The Delaney Clause, and it removed any flexibility the FDA might otherwise have. The Delaney Clause prohibits the FDA authorization of a food additive or a color additive if it has been found to induce cancer in humans or animals.

Regulatory Timeline of Red Dye 3 in the U.S.

When the FDA declined to allow Red No. 3 in cosmetics and topical drugs in 1990, the color additive was already permitted in foods and ingested drugs. Because research showed then that the mechanism dye causes cancer in rats does not apply to humans, the FDA did not take action to revoke the usage of Red No. 3 in food. For years, health advocates including CSPI (Center for Science in the Public Interest) and the Environmental Working Group (EWG) have asked FDA to reconsider that decision. Even Congressional members have signed petitions asking for the ban of Red No. 3 in foods, and eventually lawmakers cited the Delaney Clause as a basis for the ban⁶.

The safety assessment of Red Dye 3 is complicated by conflicting animal and human safety data.

While Red Dye 3 is generally known to be cancerous to laboratory animals, specifically rats, there is some consensus that this mechanism of carcinogenicity is not applicable to humans. This presents a special concern for the Agency, because the Food, Drug, and Cosmetics Act contains a clause, The Delaney Clause, prohibiting the FDA from authorizing any chemical that is shown to be carcinogenic in animals or humans at any dose. Besides the issue of carcinogenicity, there are also concerns about the effects of Red Dye 3 on neurobehavior in children.

The FDA clarified that the mechanism by which Red No. 3 causes cancer in male rats does not occur in humans, and studies on other animals and humans do not show these effects. The thyroid cancer caused in male rats is not seen in humans due to differences in metabolic and hormonal pathways between rats and humans. Male rats have a unique hormonal system that makes them susceptible to certain carcinogens. The consumption levels of the colorant used in the rat studies also do not translate to human consumption levels⁷. The FDA stated that claims that the use of FD&C Red No 3 in foods and ingested drugs puts people at risk are not supported by available scientific information and that Red No. 3 is likely not genotoxic. The agency also stated that the ban is supported by the Delaney Clause.

Controversy exists around the FDA’s implementation of the Delaney Clause as evidenced by 35 years between its prohibition of Red No. 3 in cosmetics and the recent action revoking its use in foods and ingested medications. The Delaney Clause fails to consider whether there is significant correlation between cancer risk in test animals and a realistic probability of cancer occurring in humans. This failure substantially lowers the bar for opponents to FDA approved colorants that have been determined to meet the reasonable certainty of no harm standard. A strict zero tolerance application of the Delaney Clause means that any color additive found to cause cancer in any animal is at risk of being banned even if scientific evidence shows that the animal and humans are not at risk of the same outcome and that the colorant otherwise meets established FDA standards⁵.

Food and drug manufacturers have until January 15, 2027, or January 18, 2028, respectively to remove the colorant from their products in compliance with the new requirement.

This decision will serve as a response to a petition filed more than two years ago by the Center for Science in the Public Interest (CSPI). (7) The Environmental Working Group and other public health groups have also been asking for years that FDA ban the use of Red Dye 3 use in food and drugs³.

The Environmental Working Group is a non-profit organization that advocates environmental and health issues. This activist group currently maintains a list of chemicals that it believes should not be permitted in the food supply. This list currently includes the commonly used food preservative BHA (butylated hydroxyanisole). The EWG is also requesting action on other substances such as the synthetic sweetener aspartame⁸.

It is likely that the ban action on Red No. 3 will be further addressed in court⁴. Currently, the FDA lacks conclusive data demonstrating that Red Dye 3 causes cancer in humans, which could make the ban difficult to uphold in court and may result in class action lawsuits. At a hearing in December 2024, FDA Commissioner Robert Califf acknowledged that litigation is a risk and warned that it could be challenged in the court system.

Consumer advocates also have noted concerns around other food dyes including Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3, all of which the State of California has banned from the meals, drinks and snacks served by or in public schools.

The state ban is based on concerns that children’s consumption of these dyes is linked to negative behavioral and health effects in some children. It should be noted that these six colorants are approved for use in foods by the FDA and that regulators have not established a causal link between these colorants and health effects but do recommend further research.

Other countries including Canada permit the use of Red No. 3 under the name erythrosine. Health Canada confirmed last month that the FDA ban on Red No. 3 would not cause Canadian regulators to reconsider the status of this colorant unless new and conclusive scientific evidence demonstrated a causal relationship between Red No. 3 and cancer in humans⁹. Red No. 3 is permitted in Europe and Australia and New Zealand as erythrosine for limited uses. This status is unlikely to change because of the FDA ban on the substance.

In terms of broader implications within the United States, the ban on Red No. 3 may signal a shift in FDA priorities.

Other additives associated with potential health risks such as sweeteners and preservatives may face increased scrutiny and be reevaluated in terms of safety. From a legal standpoint, the recent ban on Red No. 3 highlights the agency’s commitment to protecting public health and ensuring a safe food supply while navigating food industry dynamics.  The FDA has publicly pledged to conduct more post-market reviews of chemicals used in food and recently collected comments on the details of this plan. The FDA will continue to monitor and review all available information about the safety and toxicology of color and food additives to determine whether the use of these continues to be safe under the Food, Dye and Cosmetic Act.

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Julie Holt is a subject matter expert in the areas of food and beverage, additives, and regulatory strategy. She has beverage industry expertise and currently provides consulting support across multiple beverage categories. Ms. Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, Julie supported several food and beverage clients including a Fortune 50 company. Julie has provided global regulatory knowledge covering more than 200 countries.

Sources:

1. Ducharme, J. (2024, March 6). What foods will be impacted by FDA’s Red Dye No. 3 ban. TIME. https://time.com/7207523/fda-bans-red-dye-what-to-know/
2. U.S. Food and Drug Administration. (2009, June 18). Part I: The 1906 Food and Drugs Act and its enforcement. https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement
3. U.S. Food and Drug Administration. (2024, March 5). FDA to revoke authorization for the use of Red No. 3 in food and ingested drugs. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
4. PBS News. (2024, March 6). FDA bans red dye No. 3 from foods, nearly 35 years after it was barred from cosmetics because of potential cancer risk. https://www.pbs.org/newshour/health/fda-bans-red-dye-no-3-from-foods-nearly-35-years-after-it-was-barred-from-cosmetics-because-of-potential-cancer-risk
5. Burfoot, A. (2024, January 25). Experts examine how the FDA defines and regulates cancer-causing food additives. ScienceWriters (NASW.org). https://www.nasw.org/article/experts-examine-how-fda-defines-and-regulates-cancer-causing-food-additives
6. Center for Science in the Public Interest. (2023, October 10). FDA says it causes cancer. Yet it’s in hundreds of candies. https://www.cspinet.org/press-release/red-3-fda-petition
7. Kim, J. (2025, February 5). Red Dye No. 3 and the Delaney Clause: A relic of the past or a necessary safety measure? Petrie-Flom Center. https://petrieflom.law.harvard.edu/2025/02/05/red-dye-no-3-and-the-delaney-clause-a-relic-of-the-past-or-a-necessary-safety-measure/
8. Environmental Working Group. (2024). New report: Harmful food dyes in popular products. https://www.ewg.org/
9. Humphreys, A. (2024, March 9). The U.S. banned red dye No. 3. Why is it still allowed in Canada? National Post. https://nationalpost.com/life/food/the-u-s-banned-red-dye-no-3-why-is-it-still-allowed-in-canada