Red dye 3, a synthetic food coloring that has brightened candies, beverages, and medications for generations, has reached the end of its controversial journey in the American food supply. On January 15, 2025, the U.S. Food and Drug Administration (FDA) officially announced a ban on red dye 3, also known as erythrosine or FD&C Red No. 3, from all food, drinks, and ingested medications. This landmark decision comes after decades of scientific research linking red dye 3 to cancer in laboratory animals and raising questions about its safety for human consumption. The prohibition of red dye 3 represents a significant shift in food safety regulation and highlights the evolving understanding of the potential health impacts of synthetic food additives that have long been integrated into the American diet. For manufacturers who have relied on red dye 3 to give their products that distinctive cherry-red hue, this regulatory change necessitates reformulation efforts that will reshape the visual landscape of processed foods for years to come234.
The Long and Controversial History of Red Dye 3
The story of red dye 3 begins in the early 20th century when synthetic colorants began to replace natural dyes in food production. Red dye 3, a petroleum-derived synthetic colorant scientifically known as erythrosine, was first approved for use in food in 1907. For over a century, this vivid cherry-red colorant has been incorporated into thousands of food products, becoming a ubiquitous component of the American food landscape. Its primary function has always been purely cosmetic—to enhance the visual appeal of processed foods and beverages, making them more attractive to consumers17.
What makes the red dye 3 saga particularly perplexing is the regulatory inconsistency that has surrounded it for decades. In 1990, the FDA banned red dye 3 from cosmetics and externally applied drugs after studies demonstrated its carcinogenic potential in laboratory animals. However, at that time, the agency continued to permit its use in food products, creating what Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI), described as a “regulatory paradox.” For over three decades, red dye 3 was deemed too dangerous for lipstick but remained perfectly legal in candy consumed by children17.
The continued presence of red dye 3 in the food supply despite known safety concerns also reveals the powerful influence of industry lobbying on food regulation. As Dr. Lurie noted, “In the absence of lobbying by the industry, I think we would all expect this product to have been banned decades ago.” This delay in comprehensive regulatory action highlights the complexities and competing interests that often characterize food safety policy in the United States78.
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Health Concerns and Scientific Evidence Against Red Dye 3
The primary health concern associated with red dye 3 is its potential carcinogenic effects. Multiple scientific studies conducted over decades have demonstrated that high doses of red dye 3 can cause cancer in laboratory animals, specifically thyroid tumors in male rats. These findings formed the basis for the FDA’s 1990 decision to ban the colorant from cosmetics, as federal law mandates that a substance must be prohibited if any cancer connection is identified, regardless of the dosage required146.
While the evidence for carcinogenicity in laboratory animals is clear, the direct risk to humans has been more difficult to establish conclusively. Human exposure to red dye 3 through food and medications is significantly lower than the doses administered in animal studies. However, the FDA has taken a precautionary approach, noting that there is “evidence” of carcinogenicity in male rats exposed to elevated levels of the dye. This precautionary principle underlies the recent decision to finally remove red dye 3 from the food supply47.
Beyond cancer concerns, red dye 3 has also been associated with behavioral health issues, particularly attention deficit hyperactivity disorder (ADHD) in children. Although this connection is less extensively documented than the carcinogenic effects, it has contributed to growing consumer wariness about synthetic food dyes in general. Dr. Andrew Wong, a primary care provider for the Hartford HealthCare Medical Group, has highlighted these dual concerns, noting that research has linked red dye 3 to both cancer, especially thyroid cancer, and behavioral health problems6.
The purely cosmetic nature of red dye 3 in food products has increasingly called into question the risk-benefit ratio of its continued use. As expressed by CSPI, “The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?” This sentiment encapsulates the growing consensus that even a small potential health risk is difficult to justify when the additive serves no nutritional or functional purpose beyond visual enhancement7.
The FDA’s Decision and Implementation Timeline
The FDA’s announcement on January 15, 2025, marks the culmination of a long regulatory journey for red dye 3. The decision came in response to a petition filed in November 2022 by numerous advocacy groups and individuals, including the Center for Science in the Public Interest and the Environmental Working Group. This petition urged the FDA to prohibit red dye 3 in food, dietary supplements, and ingested drugs, citing the established cancer link and the dye’s widespread consumption, particularly among children23.
The implementation of the ban follows a phased approach, allowing industry time to reformulate products and adjust manufacturing processes. Food manufacturers have until January 15, 2027—exactly two years from the announcement—to remove red dye 3 from their products. Pharmaceutical companies and manufacturers of ingested drugs, including dietary supplements, have been granted an additional year, with a compliance deadline of January 18, 2028. This staggered timeline acknowledges the complexity of reformulation, particularly for medications where color serves as an important identifier237.
The FDA’s decision has been met with approval from food safety advocates who have long pushed for this regulatory action. Dr. Jerold Mande, an adjunct professor of nutrition at Harvard University’s T.H. Chan School of Public Health, described the ban as “long overdue” and “a small step in the right direction,” suggesting that it might signal “a renewed commitment by the agency to fulfill its responsibilities despite the numerous challenges posed by the food industry.” Similarly, Dr. Peter Lurie of CSPI celebrated the decision, stating, “At long last, the FDA is ending the contradiction of Red 3 being banned for use in cosmetics, but legal to feed to children in the form of candy”23.
Red Dye 3 in the American Diet: Prevalence and Products
Prior to the ban, red dye 3 was present in a staggering array of food products. According to the Environmental Working Group’s food database, over 2,900 food products contained this synthetic colorant. Its vibrant cherry-red hue made it particularly common in candy, especially seasonal treats associated with holidays like Valentine’s Day. Beyond confectionery, red dye 3 could be found in a wide range of products including breakfast cereals, maraschino cherries in fruit mixes, strawberry-flavored milkshakes, cakes, cookies, frozen desserts, and frostings137.
The ubiquity of red dye 3 in processed foods created significant challenges for consumers attempting to avoid it. On food labels, the substance is listed as “FD&C Red No. 3,” “FD&C Red 3,” or simply “Red 3,” requiring vigilance from shoppers concerned about its potential health effects. The presence of red dye 3 in products marketed to children has been a particular concern for consumer advocacy groups, given children’s smaller body size and developing systems7.
Dr. Wong has pointed out the potentially deceptive nature of red dye 3 in food labeling, noting that “Items that have pictures of strawberries on the label, like strawberry Pediasure, actually have no strawberry ingredients. Only a red tint from the dye.” This observation highlights how synthetic colorants like red dye 3 can create misleading impressions of fruit content in processed foods, further complicating informed consumer choice6.
In addition to food products, red dye 3 has been used in oral medications and supplements, where color serves both aesthetic and functional purposes. Distinctive coloration helps patients and healthcare providers identify medications, potentially reducing medication errors. However, the daily consumption of medicated products containing red dye 3, particularly for chronic conditions requiring long-term use, raised concerns about cumulative exposure to this synthetic colorant17.
International Perspective and Regulatory Disparities
The United States has lagged behind many other developed nations in addressing the potential risks of red dye 3. Prior to the FDA’s recent ban, numerous countries had already prohibited or restricted its use in food products. Japan, Australia, New Zealand, and countries throughout the European Union had implemented restrictions on red dye 3, reflecting a more precautionary approach to food additives with potential health concerns47.
California led the way within the United States, implementing a state-level ban on red dye 3 in food products in October 2023, more than a year before the FDA’s national prohibition. This state action may have contributed to the momentum for federal regulation, demonstrating the potential for state-level policy to influence national standards for food safety24.
The international disparities in red dye 3 regulation highlight broader differences in regulatory approaches to food additives. European regulators have generally adopted a more precautionary stance, requiring stronger evidence of safety before approving additives or maintaining their approval. In contrast, the U.S. system has historically placed a greater burden on demonstrating harm rather than establishing safety, potentially contributing to the prolonged presence of red dye 3 in the American food supply despite early evidence of potential risks4.
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Alternatives to Red Dye 3: Natural Colorants Taking Center Stage
As food manufacturers prepare to reformulate products in response to the red dye 3 ban, attention has turned to viable alternatives that can provide similar visual appeal without the associated health concerns. Natural colorants are emerging as the preferred replacements, aligning with the broader consumer trend toward clean-label products with recognizable ingredients5.
Among the natural alternatives, carmine and beetroot powder stand out as particularly promising options for achieving vibrant red hues. Carmine, derived from cochineal insects, offers excellent stability under various processing conditions, withstanding high temperatures and pH variations. It provides a vibrant red color comparable to synthetic dyes and has been widely used in dairy products, confections, and cosmetics. However, its insect origin makes it unsuitable for vegan, kosher, or halal products, limiting its application in certain market segments5.
Beetroot powder, made from dehydrated beetroot, presents a plant-based alternative that appeals to the growing vegan consumer base. Beyond its coloring properties, beetroot powder contains antioxidants that may offer health benefits, further enhancing its appeal in the clean-label marketplace. It performs well in beverages, baked goods, and candies, though it may exhibit some fading under prolonged exposure to heat or light5.
The transition to natural colorants represents not just a regulatory compliance measure but a potential opportunity for food manufacturers to respond to evolving consumer preferences. The growing demand for natural ingredients has been a significant trend in the food and beverage industry, with many consumers actively seeking products free from synthetic additives. By reformulating with natural colorants, manufacturers can potentially transform a regulatory challenge into a marketing advantage, positioning their products as cleaner and more natural5.
The Broader Context: Synthetic Food Dyes Under Scrutiny
The ban on red dye 3 exists within a broader context of increasing scrutiny of synthetic food dyes in general. The FDA has approved a total of 36 color additives for use in the United States, including nine synthetic dyes. As research continues to investigate potential health impacts of these substances, questions have emerged about whether more synthetic colorants might face similar regulatory restrictions in the future7.
Consumer advocacy groups have raised concerns about other synthetic dyes, particularly in relation to behavioral effects in children. Some research has suggested links between synthetic food colorants and hyperactivity or attention issues in sensitive individuals, though the evidence remains debated. As scientific understanding continues to evolve, the regulatory landscape for food colorants may see further changes in the coming years78.
The ban on red dye 3 after decades of allowing its use in food despite known carcinogenic potential in animals also raises questions about the effectiveness of the regulatory system for food additives. Dr. Jerold Mande’s characterization of the ban as “a small step in the right direction” suggests that some experts view this action as part of what should be a broader reassessment of food additive safety. The extended timeframe between the identification of potential risks and comprehensive regulatory action highlights potential gaps in the protection of public health2.
Conclusion: A New Chapter in Food Safety Regulation
The FDA’s decision to ban red dye 3 from food, beverages, and ingested medications marks a significant milestone in food safety regulation in the United States. After more than three decades of what many critics described as a regulatory inconsistency—prohibiting the dye in cosmetics while permitting it in food—this synthetic colorant will finally be removed from the American food supply. The two-year implementation period provides a transition window for manufacturers to reformulate products while ensuring that ultimately, consumers will no longer be exposed to a substance with established carcinogenic effects in laboratory animals123.
The journey of red dye 3 from widespread acceptance to prohibition illustrates how scientific understanding, consumer advocacy, and regulatory approaches to food additives evolve over time. What was once considered a harmless colorant became increasingly questioned as research revealed potential health concerns and as consumer preferences shifted toward more natural alternatives. The prolonged presence of red dye 3 in the food supply despite early evidence of risk also serves as a reminder of the complex interplay between scientific evidence, industry interests, and regulatory action in determining food safety standards178.
As food manufacturers pivot to alternative colorants, consumers may notice subtle changes in the appearance of familiar products. These visual shifts, though minor, will represent a significant advancement in removing unnecessary potential carcinogens from the food supply. In the words of the Center for Science in the Public Interest, when a food additive serves a purely aesthetic purpose, even a small cancer risk becomes difficult to justify. The ban on red dye 3 affirms this principle, prioritizing public health over cosmetic food properties and potentially setting a precedent for more precautionary approaches to food additive regulation in the future17.
References:
- Why Is Red Dye No. 3 Banned in Cosmetics but Still Allowed in Food?
- FDA bans red dye No. 3 from food, drinks and ingested drugs in the US
- FDA bans Red No. 3, artificial coloring used in beverages, candy and other foods
- US bans red dye 3 from some frosting, candy and medicine
- What foods use Red Dye No. 3? What to know about the newly banned food coloring
- Red Dye No. 3 Is Banned in the US but These 9 Foods Still Contain It
- FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
- US bans controversial red food dye, decades after scientists raised alarm
