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Is red dye No 3 banned by the FDA? The 2025 Ruling Explained

4 min read

In January 2025, the U.S. Food and Drug Administration (FDA) officially banned Red Dye No. 3 (also known as erythrosine) in food and ingested drugs. This action followed decades of concern regarding the dye's potential health effects.

Quick Summary

The FDA banned Red Dye No. 3, a synthetic color additive, from food and drugs due to the Delaney Clause after animal studies linked it to cancer. The ban mandates product reformulation by 2027 or 2028, following advocacy and prior restrictions.

Key Points

  • FDA Ban: The FDA banned Red Dye No. 3 from food and ingested drugs in January 2025.

  • Delaney Clause: The ban was mandated by the Delaney Clause, which prohibits cancer-causing additives.

  • Compliance Timeline: Manufacturers have until January 2027 (food) and January 2028 (drugs) to reformulate products.

  • Prior Cosmetic Ban: The FDA had already banned the dye from cosmetics in 1990.

  • California's Role: California passed a state law banning Red Dye No. 3, accelerating federal action.

  • Ingredient Labels: Consumers can check ingredient labels for "FD&C Red No. 3" or "erythrosine".

  • Natural Alternatives: Many companies are using natural colorings like beet juice and carmine.

In This Article

What is Red Dye No. 3?

Red Dye No. 3, scientifically known as erythrosine or E127, is a synthetic color additive derived from petroleum. This dye has been used to give products a cherry-red color. Unlike natural colors, Red Dye No. 3 has no nutritional value and is added for visual appeal. It was used in various consumer products, and has the potential to disrupt hormones.

The Path to the Ban: A Regulatory Timeline

  • 1969: The FDA approved Red Dye No. 3 for use in foods and drugs.
  • 1980s: Studies indicated that high doses of Red Dye No. 3 caused thyroid cancer in male lab rats.
  • 1990: The FDA banned Red Dye No. 3 from cosmetics and topical drugs but did not ban it from food, citing industry pressure.
  • 2022: The Center for Science in the Public Interest (CSPI) and other groups petitioned the FDA to ban all remaining uses of Red Dye No. 3.
  • October 2023: California passed the California Food Safety Act, banning Red Dye No. 3 and three other additives, effective January 2027.
  • November 2024: Members of Congress sent a letter to the FDA urging a ban on the dye.
  • January 2025: The FDA announced it was revoking authorization for the use of Red Dye No. 3 in food and drugs, enacting the ban nationwide.

How the FDA Ban Affects Consumers

The ban was announced in 2025, but it does not take immediate effect to give manufacturers time to comply. Food manufacturers have until January 15, 2027, to reformulate their products, while drug manufacturers have until January 18, 2028. Until these dates, products containing the dye may still be available. Consumers can avoid it by reading ingredient labels for “FD&C Red No. 3,” “Red 3,” or “Erythrosine”.

Products Containing Red Dye No. 3

Prior to the ban, Red Dye No. 3 was found in products like:

  • Candies (candy corn, peppermints, jelly beans)
  • Maraschino cherries
  • Fruit cocktails
  • Cakes, frostings, and decorating gels
  • Popsicles
  • Some beverages, including sodas and sports drinks
  • Certain medications and vitamins
  • Strawberry-flavored milk and ice cream products

The Legal Basis: The Delaney Clause and Animal Studies

The FDA's decision was legally mandated by the Delaney Clause, a provision of the Federal Food, Drug, and Cosmetic Act. This clause requires the banning of any food or color additive found to induce cancer in humans or animals, regardless of the exposure level. The FDA has indicated that the mechanism causing thyroid tumors in male rats is not relevant to human health, but the legal requirements of the Delaney Clause necessitated the ban. Some studies have also suggested other potential health issues, such as behavioral problems in children, linked to Red Dye No. 3.

Comparing Red Dye No. 3 with Natural Alternatives

This table illustrates the differences between Red Dye No. 3 and natural colorings.

Feature Red Dye No. 3 (Erythrosine) Natural Alternatives (e.g., Beet Juice, Carmine)
Origin Derived from petroleum Sourced from plants (beets, radishes, purple carrots) or insects (cochineal)
Cost Less expensive to produce Generally more expensive due to processing and sourcing
Color Stability Highly stable to light and heat Variable stability; some may degrade with heat or light exposure
Processing Impact Unaffected by pH levels Color can be highly dependent on pH; some turn brown or blue
Shelf Life Long shelf life Typically shorter shelf life compared to synthetic dyes
Consumer Perception Viewed with concern due to health risks Often perceived as a healthier, "clean label" option

The Rise of Natural Food Colors

In response to consumer demand for natural ingredients, many food companies began phasing out synthetic dyes like Red Dye No. 3, even before the federal ban. This shift has spurred innovation in natural food colorings, with alternatives like beet juice, anthocyanins from red cabbage, and carmine (from cochineal insects) becoming more common. This reflects an evolving consumer preference for less processed foods and more transparent labeling.

Red Dye No. 3 vs. Other Synthetic Dyes

The FDA ban is specific to Red Dye No. 3, not all synthetic red dyes. Red Dye No. 40, another synthetic red color, remains approved by the FDA, although concerns about its potential impact on health have been raised. The FDA's action on Red Dye No. 3 has increased public attention to food additives and the need for safety re-evaluations.

Conclusion: A Move Toward Greater Transparency

The FDA's ban on Red Dye No. 3 represents a significant step in updating food safety standards in the United States. The decision, driven by consumer advocacy and state legislation, was based on the Delaney Clause. For consumers, the ban signals a move toward ingredient transparency. It reinforces the importance of reading product labels and staying informed about the ingredients in the food supply. While questions remain about other food additives, this ban sets a precedent for prioritizing public health, even if compliance takes time.

Additional Additives Information

The Food Standards Agency in the UK requires a warning label for six specific dyes that may have an adverse effect on activity and attention in children. Consumers can stay informed and make healthier choices by paying close attention to these and other ingredient details on food packaging.

For more information on the impact of food regulations, visit the FDA website.

Frequently Asked Questions

The ban was announced in January 2025. Manufacturers have a grace period to comply. The deadline for food products is January 15, 2027, and for ingested drugs, it's January 18, 2028.

The FDA banned Red Dye No. 3 based on the Delaney Clause, which requires a ban on any additive found to cause cancer in animals or humans. The ban was prompted by animal studies linking the dye to thyroid cancer in male rats.

The Delaney Clause is a law that prohibits the FDA from approving any color additive for ingestion if it causes cancer in humans or animals. The law mandates action, even if the risk to humans is deemed low.

Before the ban, Red Dye No. 3 could be found in candies, maraschino cherries, fruit cocktails, strawberry milk, ice creams, and some medications.

No, Red Dye No. 3 (erythrosine) is different from Red Dye No. 40 (Allura Red AC). While Red Dye No. 3 was banned, Red Dye No. 40 remains approved by the FDA.

Natural alternatives include beet juice, carmine (derived from cochineal insects), anthocyanins (from berries, radishes, or red cabbage), and paprika.

Yes, many countries, including the European Union, Australia, and New Zealand, had already restricted or banned the use of Red Dye No. 3 in food prior to the FDA's 2025 announcement. California also passed a state ban in 2023.

The FDA requires that food labels list all color additives by name. Consumers can check ingredient lists for "FD&C Red No. 3" or "erythrosine." Some companies had already voluntarily removed the dye from their products before the ban.

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Medical Disclaimer

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