January 15, 2025

The U.S. Food & Drug Administration (FDA) has announced a ban on Red Dye No. 3, a synthetic color additive commonly used in various food and drug products. Red Dye No. 3, also known as FD&C Red No. 3 or erythrosine, is a synthetic food coloring derived from petroleum. Approved for use in the United States since 1907, it is widely used to create a vibrant red color in various foods and beverages. It is commonly found in candies, frostings, frozen desserts, and snack cakes. This decision, published in a recent update, follows a 2022 petition calling for its removal due to safety concerns. Manufacturers will have until January 15, 2027, to remove the dye from food products and until January 18, 2028, to eliminate it from drugs. Products affected include candies, baked goods, flavored milks, over-the-counter medications, cereals, and other processed foods.

The ban was prompted by studies that linked the dye to cancer in male laboratory rats after prolonged exposure. While no evidence currently suggests that the dye causes cancer in humans, the Federal Food, Drug, and Cosmetic Act prohibits the use of additives shown to cause cancer in either humans or animals, leading to the FDA’s decision.

Concerns over synthetic dyes extend beyond Red Dye No. 3. Americans now consume significantly more food dye than in previous decades, as artificial colors have become prevalent in processed foods like breakfast cereals and ice creams. Many synthetic dyes, including Red 40, Yellow 5, and Yellow 6, contain compounds linked to cancer in some studies. Research has also associated these dyes with behavioral issues in children, such as hyperactivity, learning difficulties, and irritability. Studies suggest that even children without ADD or ADHD may experience hyperactive behavior after consuming synthetic dye blends. In response to these concerns, some countries have implemented stricter regulations. For example, the European Union requires food containing synthetic dyes to carry warning labels, encouraging manufacturers to seek natural alternatives. While these dyes remain widely used in the United States, preliminary evidence indicates that many children may have mild sensitivities to them, with a smaller subset being highly sensitive.

Synthetic dyes are often found in foods that also have other nutritional drawbacks, such as high levels of sugar, calories, and unhealthy fats. For those looking to avoid synthetic dyes, opting for products with natural colorants like beet, carotenes, annatto, or capsanthin (a paprika extract) is a healthier alternative. The USDA-certified organic label ensures the absence of synthetic dyes, but foods labeled “made with organic ingredients” may still include them. Additionally, terms like “artificial color” or “color added” often indicate the use of nature-derived pigments, as synthetic dyes must be listed by name.

The ban on Red Dye No. 3 marks a step toward addressing concerns about synthetic food dyes, but the broader issue of artificial colorants in food remains. Consumers can make informed choices by reading labels and prioritizing whole, minimally processed foods in their diets.

For more information or specific inquiries about the ban, the FDA can be reached at 1-888-INFO-FDA.