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Is red dye no 3 banned in food? The definitive guide to the FDA's decision

3 min read

In January 2025, the U.S. Food and Drug Administration (FDA) officially banned the use of Red Dye No. 3 in food and ingested drugs, a decision that followed decades of advocacy. This action effectively answers the question, "Is red dye no 3 banned in food?" and gives manufacturers until 2027 to reformulate their products.

Quick Summary

The U.S. FDA has banned the food additive Red Dye No. 3 after long-standing health concerns. The federal ban gives manufacturers a 2027 deadline to remove the dye from food products.

Key Points

  • Federal Ban: The U.S. Food and Drug Administration (FDA) officially banned Red Dye No. 3 in food and ingested drugs in January 2025.

  • Carcinogenic Link: The ban was based on 1980s animal studies showing the dye causes thyroid cancer in male rats, which triggered the Delaney Clause of the Food, Drug, and Cosmetic Act.

  • Implementation Deadline: Manufacturers must remove the dye from food products by January 2027 and from ingested drugs by January 2028.

  • Global Alignment: The federal ban brings the U.S. in line with countries like those in the European Union, Australia, and New Zealand, which have long restricted or banned the dye.

  • Precedent Set by States: California’s 2023 state-level ban on Red Dye No. 3 contributed significant pressure for the subsequent federal action.

  • Product Impact: The ban affects numerous food products, including candies, baked goods, maraschino cherries, and certain beverages.

In This Article

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.

Frequently Asked Questions

Red Dye No. 3, also known as Erythrosine or FD&C Red No. 3, is a synthetic, petroleum-based color additive used to give foods and drugs a bright, cherry-red color.

The FDA banned Red Dye No. 3 in cosmetics in 1990 but delayed action on food for decades due to bureaucratic reasons and debate over the relevance of animal study findings to humans. Action was spurred by state laws, particularly California's 2023 ban.

For food products and beverages, the federal ban takes effect in January 2027. For ingested drugs, the deadline for reformulation is January 2028.

The FDA emphasized that while the dye caused cancer in male lab rats at high doses, the specific mechanism is not believed to apply to humans. The ban was legally required by the Delaney Clause due to the evidence in animals.

Commonly affected products include certain candies, maraschino cherries, cake decorations, some fruit cocktails, and strawberry-flavored drinks or milk.

Many companies are transitioning to natural alternatives like beet juice, carmine (made from insects), or pigments from purple sweet potatoes and red cabbage to achieve a red color.

No, Red Dye No. 40 is not included in this federal ban and remains an approved food additive, though it and other synthetic dyes face ongoing scrutiny from consumer groups and state-level legislative proposals.

Yes, products containing the dye may still be available for purchase until manufacturers meet the January 2027 deadline. Consumers can check the ingredient list for 'FD&C Red No. 3' or 'E127' to identify the dye.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.