FD&C Red No. 3: The Specifically Banned Dye
The red dye recently targeted by federal regulators is FD&C Red No. 3, also known as erythrosine. The decision to ban it was a landmark move, concluding a long and complex regulatory process. Announced in January 2025, the ban requires food and beverage manufacturers to eliminate the dye from their products by January 2027, with a slightly later deadline for drug manufacturers. This rule responded to a 2022 petition by consumer advocacy groups and built upon earlier state-level legislation.
Why Was Red Dye No. 3 Banned?
The primary reason for the ban dates back to the 1980s when animal studies linked high doses of Red 3 to thyroid cancer in male rats. The Delaney Clause of the Federal Food, Drug, and Cosmetic Act prohibits the FDA from approving any food or color additive shown to cause cancer in humans or animals. Although the FDA indicated the cancer mechanism in rats may not occur in humans, the Delaney Clause mandated the ban. This decision resolved a regulatory inconsistency where Red 3 was banned in cosmetics in 1990 due to cancer concerns but remained in food for over 30 years.
Confusion with Other Red Dyes
It is important to differentiate between Red Dye No. 3 and other red colorants to avoid consumer confusion. Common alternatives include Red Dye No. 40, which is still legal, and historically, Red Dye No. 2 was also a subject of controversy.
Red Dye No. 2 (Amaranth)
Red Dye No. 2, or amaranth, was banned in the US in 1976 due to concerns about a potential link to tumors in rats from a Soviet study. Other studies were inconclusive, but the ban was implemented. This earlier ban is sometimes confused with the current regulation of Red 3.
Red Dye No. 40 (Allura Red AC)
Red Dye No. 40 is a separate dye from Red 3 and is currently approved by the FDA. Despite its legal status, Red 40 has faced controversy, with some studies suggesting a link to hyperactivity in sensitive children. It is subject to stricter regulations or bans in several other countries. Red 40 is often used by food companies as a replacement for Red 3.
Comparison of Red Dyes
| Feature | FD&C Red No. 3 (Erythrosine) | FD&C Red No. 40 (Allura Red AC) | FD&C Red No. 2 (Amaranth) |
|---|---|---|---|
| Current Status (USA) | Banned for food & ingested drugs (effective 2027/2028) | Still approved by the FDA | Banned since 1976 |
| Primary Concern | Linked to thyroid cancer in rats | Potential link to hyperactivity in some children | Suspected carcinogen in animal studies |
| Regulatory Action | Recent FDA ban in 2025 based on Delaney Clause | Reviewed by FDA but no ban imposed; regulated in other countries | Ban implemented in 1976 |
| Replacement Use | Often replaced by Red 40 or natural alternatives | Frequently used to replace other red dyes | Initially replaced by Red 40 after its ban |
Shifting Towards Natural and Healthier Alternatives
Growing consumer awareness of artificial dyes has led to a preference for natural food colors derived from fruits, vegetables, flowers, and spices. These often offer a safer and more nutritious alternative.
- Beetroot: Provides a vibrant red or pink hue and is a common substitute in products like ice cream and candies.
- Paprika Oleoresin: Offers a red-orange color derived from paprika.
- Anthocyanins: Provide red and purple tones, extracted from sources like red cabbage or elderberry.
- Carmine: A natural dye from cochineal insects, providing a powerful red, though not vegan.
- Lycopene: Found in red fruits like tomatoes, offering red color and antioxidant benefits.
Many foods containing artificial dyes are highly processed. Choosing a diet rich in whole, unprocessed foods naturally minimizes exposure to artificial colors and provides greater nutritional value. Reading ingredient labels is essential for consumers to make informed decisions.
Conclusion
The ban on FD&C Red No. 3 is a significant step in food safety regulation, addressing a long-standing issue. It encourages consumers to be mindful of ingredients and highlights the trend towards cleaner food labeling. While dyes like Red 40 are still used, the demand for healthier, natural alternatives continues. A nutritious diet based on whole foods is the best way to limit consumption of artificial additives.
Center for Science in the Public Interest: Red 3: FDA finally bans cancer-causing food dye