A Long-Awaited Federal Ban
For decades, consumer advocates and health organizations pushed for a ban on Red Dye No. 3 (erythrosine or FD&C Red No. 3) due to links to cancer in rats. The FDA banned its use in cosmetics in 1990 but allowed it in food, citing bureaucratic issues and low human risk. The 2023 California Food Safety Act, banning Red Dye No. 3 within the state, pressured the FDA for federal action. In January 2025, the FDA banned Red Dye No. 3 in food and ingested drugs. Food products must comply by January 2027.
Why Was Red Dye No. 3 Banned?
The ban is based on the Delaney Clause, which prohibits FDA approval of color additives causing cancer in animals. Studies from the 1980s showed Red Dye No. 3 caused thyroid tumors in male rats, fulfilling the Delaney Clause requirement. While the FDA believes the cancer mechanism in rats is unlikely in humans, the clause mandated action. Concerns about potential neurobehavioral issues in children were also a factor. The ban aligns the U.S. with many countries, including those in Europe, that already restrict or ban the dye.
Foods and Products Impacted by the Ban
Red Dye No. 3 is a synthetic color additive providing a bright red color to numerous processed foods. Products traditionally containing it include:
- Candies: Candy corn, some gummy candies, and seasonal treats.
- Baked Goods: Red and pink icings and certain cake mixes.
- Maraschino Cherries: A significant user, though many brands now use alternatives like carmine.
- Frozen Desserts: Some strawberry-flavored ice creams and pops.
- Beverages: Certain strawberry milks and fruit-flavored drinks.
- Ingested Drugs: Oral medications, with a later compliance deadline.
Manufacturers are switching to natural colorings from sources like beet juice, purple sweet potatoes, and carmine.
Comparison of US and European Red Dye No. 3 Regulations
| Feature | United States (Post-Jan 2025 FDA Ban) | European Union (Since 1994) |
|---|---|---|
| Regulatory Status | Banned for use in food, beverages, and ingested drugs. | Restricted, with use limited to a few specific products, like cocktail cherries. |
| Driving Factor | Federal action spurred by California's 2023 state ban and a 2022 petition from health groups. Required by the Delaney Clause. | Early awareness of animal studies and a proactive stance on food additive safety. |
| Compliance Deadline | Manufacturers must reformulate food products by Jan 2027 and drugs by Jan 2028. | Compliance has been in effect for decades. |
| Primary Legal Justification | The Delaney Clause, which mandates banning additives shown to cause cancer in animals. | Precautionary principle regarding potential health risks. |
| Impact on Imports | Imported foods must comply with the new US regulations. | All foods, including imports, must comply with EU standards. |
The Path to Red Dye No. 3's Prohibition
The ban's timeline reflects the lengthy food additive regulation process. Red Dye No. 3 remained in food for over 30 years after its cosmetic ban. Federal action was eventually driven by state law and advocacy. This has spurred debate on FDA oversight of food chemicals. For more on food colorants, the Center for Science in the Public Interest offers resources.
Conclusion: Navigating a New Food Landscape
Red Dye No. 3 is now banned in U.S. food. By 2027, many bright red foods will use alternative colorings. While the ban was based on the Delaney Clause due to animal studies, not proven human carcinogenicity, it removes a questionable chemical. Consumers can check labels for "FD&C Red No. 3" or "E127" and choose naturally colored options.