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What is red no. 3 used for and why was it banned?

4 min read

In a historic move in January 2025, the U.S. Food and Drug Administration (FDA) finalized a ban on Red No. 3 from the food and ingested drug supply, citing safety concerns. This action effectively ended the use of the petroleum-based dye, also known as Erythrosine or FD&C Red No. 3, which was once commonly used to impart a vibrant, cherry-red color to a wide array of consumer products.

Quick Summary

This article explores the former uses of Red No. 3 in food, drugs, and cosmetics, examining its long and controversial history. It details the scientific evidence linking the dye to health risks and explains the rationale behind its recent prohibition in the United States.

Key Points

  • Former Primary Use: Red No. 3 was historically used as a synthetic, petroleum-based color additive to give a bright, cherry-red hue to thousands of processed foods, drinks, and oral medications.

  • FDA Ban Rationale: The U.S. Food and Drug Administration (FDA) finalized a ban on Red No. 3 in January 2025, citing links to cancer in animal studies based on the Delaney Clause.

  • Long-Standing Controversy: For over 30 years, Red No. 3 was controversially banned in cosmetics but still permitted in food, despite known safety concerns.

  • Regulatory Alignment: The FDA ban brings U.S. regulations in line with those of Europe, Australia, and New Zealand, which have long restricted or banned the additive.

  • Industry Transition: Food and drug manufacturers have until 2027 and 2028, respectively, to reformulate products, with many already shifting to natural alternatives like beet juice and carmine.

  • Consumer Action: Consumers can avoid Red No. 3 by checking ingredient lists for 'FD&C Red No. 3' or 'Erythrosine' and opting for products with natural colorings.

In This Article

What is Red No. 3 used for historically?

Before its final prohibition in the U.S., Red No. 3 was a ubiquitous synthetic color additive, valued for its bright, eye-catching cherry-red hue that was resistant to heat. It was used extensively across various industries, primarily to enhance the visual appeal of products that would otherwise appear less attractive. Its uses spanned consumer goods from foods and beverages to pharmaceuticals and cosmetics, serving no nutritional or flavor-enhancing purpose.

Food products

In the food industry, Red No. 3 gave its signature color to thousands of products, many of which were popular with children. The dye made everything from holiday-themed candies to common fruit products look more vibrant and enticing. Some of the most common applications included:

  • Candies: Especially seasonal treats like conversation hearts, candy corn, and other gummies.
  • Baked Goods: Used in frostings, icings, and cake mixes to create colorful decorations.
  • Fruit Products: Tinted maraschino cherries, canned fruit cocktails, and other processed fruit mixes.
  • Beverages: Found in certain sodas, fruit-flavored drinks, and strawberry milk.
  • Processed Meats: Added to products like sausage and vegetarian bacon to simulate a more natural red color.

Ingested drugs and dietary supplements

Red No. 3 was also widely used to color oral medications and supplements. The inclusion of a bright color was often for aesthetic purposes, helping to make medicines, particularly those for children, seem less intimidating. It could be found in:

  • Cough syrups
  • Gummy vitamins
  • Select prescription and over-the-counter medications like acetaminophen and fluoxetine

Cosmetics and topical applications

While its use in food continued for decades, Red No. 3 was banned for use in cosmetics and topical drugs in the U.S. much earlier, in 1990. The dye, made from a petroleum base, was used in lipsticks and externally applied medications, but animal studies linking it to cancer prompted this initial ban.

The long road to the FDA ban on red no. 3

For over 30 years, an unusual regulatory paradox existed where Red No. 3 was deemed too unsafe for lipstick but still permitted in candies and other consumables. This came despite studies from the 1980s that showed a link between high doses of Red No. 3 and thyroid tumors in male lab rats. The Federal Food, Drug, and Cosmetic Act contains a provision known as the Delaney Clause, which requires the FDA to ban any additive found to cause cancer in either humans or animals. While the FDA acknowledged the findings, it did not take action to revoke authorization for food and ingested drugs until a 2022 petition from public interest groups spurred a re-evaluation.

The FDA's final decision in January 2025 gave food and drug manufacturers a deadline to remove the dye from their products. This regulatory action aligns the U.S. with much of the rest of the developed world, as countries in Europe, as well as Australia and New Zealand, had already banned or severely restricted the use of Red No. 3 in food.

Natural vs. Synthetic: What is red no. 3 used for compared to alternatives?

With the ban on Red No. 3, manufacturers have been required to pivot towards safer alternatives. The industry is increasingly relying on natural colorants derived from plant-based sources to achieve red hues.

Feature Red No. 3 (Erythrosine) Natural Alternatives (e.g., Beet Juice, Carmine)
Source Petroleum-based synthetic chemical Plant-based (beet juice, radish) or insect-derived (carmine)
Color Quality Very bright, consistent, and heat-stable cherry-red Can vary in shade and stability depending on the source and processing method
Health Concerns Linked to thyroid tumors in animal studies; potential behavioral effects in children Generally considered safer, with long histories of safe use in food
Availability Now banned for food and ingested drugs in the U.S. Widely available and increasingly used by manufacturers
Consumer Perception Negative, associated with artificial ingredients and health risks Positive, aligned with 'clean label' and natural food trends

Identifying and avoiding red no. 3

Until the final deadlines for removal pass, consumers must remain vigilant. Federal regulations require manufacturers to list color additives by their full names on ingredient labels. When checking product packaging, look for any of the following names to identify and avoid the dye:

  • FD&C Red No. 3
  • Red 3
  • Erythrosine

Many companies, such as Ferrara Candy Company, have been actively phasing out Red No. 3 in recent years and reformulating products with alternatives. Checking the ingredient list is the most reliable way to confirm a product's composition. For those seeking to avoid all synthetic dyes, organizations like the Environmental Working Group provide extensive databases of products.

Conclusion: A new chapter for food coloring

The definitive ban on Red No. 3 marks a significant change in the food and drug landscape, concluding a decades-long debate over its safety. Historically, the petroleum-based dye was used to add vibrant red coloring to thousands of consumer products, from candies to medications, with no functional benefit beyond aesthetics. The accumulation of evidence linking it to cancer in animal studies and concerns over potential neurobehavioral effects ultimately led the FDA to align its regulations with international standards. This shift pushes the industry towards safer, naturally derived color alternatives, giving consumers greater confidence in the ingredient labels of their food and medicine. For individuals aiming to avoid synthetic additives, reading labels carefully and choosing products that have already been reformulated is the best course of action.

Center for Science in the Public Interest: Red 3 - FDA finally bans cancer-causing food dye

Frequently Asked Questions

The FDA banned Red No. 3 based on the Delaney Clause, a provision of the Federal Food, Drug, and Cosmetic Act. Studies conducted in the 1980s linked high doses of the dye to thyroid cancer in male lab rats, which legally obligated the agency to prohibit its use in food and ingested drugs.

Red No. 3 is also commonly known as Erythrosine or FD&C Red No. 3. It is listed under these names on product ingredient labels.

Historically, Red No. 3 was used in thousands of products, including popular candies like conversation hearts and candy corn, maraschino cherries, fruit cocktails, bright red frostings, gummy vitamins, and certain cough syrups.

Manufacturers of food products have until January 15, 2027, to remove Red No. 3 from their formulations and comply with the ban.

No, the ban specifically targeted Red No. 3. Other artificial red dyes, such as Red No. 40, are still permitted in the U.S., although they remain a subject of concern for some health advocates.

The FDA requires that all color additives be listed on product labels. You can check the ingredient list for the specific names 'FD&C Red No. 3', 'Red 3', or 'Erythrosine'.

In place of Red No. 3, many companies are switching to natural colorants. Common examples include beet juice, carmine (derived from cochineal insects), purple sweet potato, and radish extracts.

Yes, Red No. 3 was banned from use in cosmetics and topical drugs in the U.S. in 1990, based on earlier evidence linking it to cancer in lab rats.

While many countries, including those in the European Union, Australia, and New Zealand, have banned or restricted its use, some global regulations may differ. However, U.S. imports must comply with the new ban.

References

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Medical Disclaimer

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