MARIANNE ADAMS—Color plays a significant role in the foods we eat and the products we use, influencing everything from taste perceptions to emotional responses. For centuries, the colors we associate with food and beverages have been carefully crafted—often artificially––to enhance their appeal long before we take our first bite or sip. This is especially evident in American cuisine, where artificial additives often stain the color palette of our plates.
Red, a color frequently used to evoke energy, excitement, and indulgence, is one of the most popular color choices in food manufacturing and marketing. To achieve this vibrant hue, companies have used synthetic food dyes like Red Dye No. 3 for decades. But is the red dye an innocent visual appeal? Or is it a red herring, distracting us from the potential health risks hidden in the ingredients? The U.S. Food and Drug Administration’s (FDA) recent ban on Red Dye No. 3 provides an answer.
Red Dye No. 3––also known as FD&C Red No. 3, erythrosine, or Red 3––is a petroleum-based colorant, giving foods, drinks, and medications a striking “cherry-red” hue. A long grocery list of common food and drink items contain Red Dye No. 3, including sodas, maraschino cherries, baking mixes, cereals, sprinkles, frosting, popsicles, and more. In fact, over 9,000 brand-name food products in the U.S. have relied on Red Dye No. 3 to enhance their visual appeal. Additionally, Red Dye No. 3 is often found in gummy vitamins and cough syrups.
In November of 2022, consumer advocacy groups, including the Center for Science in Public Interest (CSPI), petitioned the FDA to ban all remaining uses of Red Dye No. 3. They argued the dye should be barred due to its potential cancer risk and its widespread use by U.S. consumers, specifically children. The petition presented data showing that Red Dye No. 3 causes cancer in male laboratory rats exposed to high levels of the dye due to a hormonal mechanism specific to male rats.
Based on these findings, on January 16, 2025, the FDA announced the ban of Red Dye No. 3 “as a matter of law” in food, beverages, dietary supplements, and oral medicines. While there is currently no evidence showing that Red Dye No. 3 is a carcinogen for humans, the FDA’s decision was grounded in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits additives that have been found to induce cancer in humans or animals. This decision follows in the footsteps of California, whose government banned Red Dye No. 3 in October 2023. Additionally, the ban aligns the U.S. with much of the world, as Red Dye No. 3 is largely restricted in the European Union, Australia, and New Zealand.
The effort to prohibit Red Dye No. 3 is not a new movement. The usage of Red Dye No. 3 first came under scrutiny in the late 1970s and early 1980s, when research linked the dye with thyroid cancer in male rats. This led to the FDA’s 1990 ban of Red Dye No. 3 in cosmetics and topical drugs. Two years later, in 1992, the FDA announced its intention to bar the usage of Red Dye No. 3 in food and ingested drugs. Despite this, Red Dye No. 3 continued to be authorized for use in such products. For decades, this regulatory paradox raised troubling questions about why an additive was “illegal for use in lipstick, but perfectly legal to feed children in the form of candy.”
With the FDA’s recent order on Red Dye No. 3, food and drug manufacturers now face deadlines to reformulate any products containing the dye. Food manufacturers have until January 2027 to remove the dye from their products, while drug manufacturers will have an additional year. So, what does this mean for manufacturers? Some companies may turn to synthetic alternatives like Red Dye No. 40, which is still authorized by the FDA, even though it has been associated with separate health concerns, such as behavioral issues in children. Others might consider exploring natural substitutes such as fruit and vegetable extracts.
Advocates urge that the transition should not be overly burdensome for companies, as many large food corporations already comply with similar regulations in Europe. However, reformulation will undoubtedly present challenges. Importantly, the ban may open the door to multiple avenues of litigation. Consumer class actions may emerge, with manufacturers facing damage claims related to alleged health risks from past consumption of products containing Red Dye No. 3. Additionally, manufacturers may encounter conflicts with suppliers over ingredient changes, especially if existing contracts do not account for the regulatory shift or international trade considerations.
Overall, the ban of Red Dye No. 3 is a significant step in the broader conversation about food safety and the use of artificial additives. While the decision may feel like a win for public health, it is only a piece of a much larger puzzle. Other synthetic dyes still remain in the food supply, and the science on their long-term effects continues to evolve. As the ban takes effect, the next time you reach for a brightly colored candy or snack, take a moment to read the nutrition label and consider what might be behind that vibrant hue.
