What is FD&C Red No. 3?
FD&C Red No. 3, commonly called Red 3 or erythrosine, is a synthetic, petroleum-based dye used to impart a bright, cherry-red hue to a wide array of products. It was first approved for use in the United States in 1907.
Where was Red 3 typically used?
Prior to the 2025 ban, Red 3 was a common ingredient in thousands of consumer products, including foods like candies, baked goods, maraschino cherries, some beverages, and processed meats, as well as ingested drugs like gummy vitamins and cough syrups.
Foods that formerly contained Red 3 included:
- Candies (e.g., candy corn, conversation hearts, gumdrops)
- Baked goods (e.g., icings, frostings, toaster pastries, snack cakes)
- Maraschino cherries
- Some strawberry-flavored beverages and milk
- Frozen desserts (e.g., ice pops, ice cream)
- Certain processed meats (e.g., sausages, bacon bits)
Ingested drugs that formerly contained Red 3 included:
- Gummy vitamins
- Cough syrups
- Various coated pills
The long road to the FDA ban
Red 3's regulatory history is complex. The Delaney Clause of 1958 mandated that the FDA prohibit food additives found to cause cancer in humans or animals. In the 1980s, studies on male rats linked high doses of Red 3 to thyroid tumors. This led the FDA to ban Red 3 in cosmetics and external drugs in 1990. However, the dye remained legal in food and ingested drugs for over three decades due to regulatory challenges. Advocacy efforts and a 2023 ban by California eventually prompted the FDA's decision to ban the dye in January 2025.
The FDA's 2025 ban
The FDA's final rule, announced on January 15, 2025, revokes authorization for Red 3 in food and ingested drugs. The ban includes phase-in periods: food manufacturers must comply by January 15, 2027, and drug manufacturers by January 18, 2028.
Health concerns associated with Red 3
In addition to the cancer link that led to the ban, other health concerns have been associated with Red 3 and artificial dyes.
- Thyroid Dysfunction: Animal studies suggested Red 3 could interfere with thyroid hormone regulation.
- Behavioral Issues in Children: Some research links artificial dyes, including Red 3, to hyperactivity in sensitive children.
- Neurotoxicity: Studies indicate potential toxic effects on the brain from Red 3.
Natural alternatives to Red 3
With the upcoming ban, manufacturers are using natural alternatives. Consumers can also opt for products with these colorants.
| Natural Red Dye Alternative | Source | Common Uses | Notes |
|---|---|---|---|
| Beet Juice / Betacyanin | Beetroots | Frozen desserts, yogurts, candies | Provides shades from intense pink to rich red; good stability under moderate heat and light. |
| Anthocyanin | Red radish, black carrot, sweet potato | Beverages, confectionery | Provides vibrant red, blue, or purple hues depending on pH. |
| Carmine / Cochineal Extract | Cochineal insects | Drinks, confectionery, baked goods | Offers stable orange-to-red shades. Not suitable for vegans or those with shellfish allergies. |
| Paprika Oleoresin | Paprika peppers | Spice blends, processed meats, snacks | Delivers orange-red colors with a mild pepper flavor. |
| Hibiscus Flower Extract | Hibiscus flowers | Beverages, syrups, baked goods | Provides a natural pink-to-red hue. |
Conclusion
The FDA's ban on Red 3 is a significant food safety change, addressing decades-long concerns, particularly the link to cancer in animal studies. The ban requires food and drug manufacturers to reformulate products. Consumers can identify Red 3 by checking ingredient labels for "FD&C Red No. 3" and choose products with natural colorants like beet juice or anthocyanins. This move is part of a larger trend toward natural ingredients and cleaner product labels.