If you’ve ever picked up a brightly colored candy or a strawberry-flavored treat, chances are you’ve encountered Red Dye No. 3, a synthetic food dye known for its vibrant hue. Despite its eye-catching appeal, Red Dye No. 3 has long been surrounded by controversy due to potential health risks. Recently, the U.S. Food and Drug Administration (FDA) announced a ban on this additive after evidence linked it to cancer in animal studies. Here’s what you need to know.
What Is Red Dye No. 3?
Red Dye No. 3, or erythrosine, is a petroleum-derived synthetic dye that gives foods, drinks, and medicines a bright red color. Approved for use in the U.S. since 1907, it has been a common ingredient in:
- Candies and seasonal treats
- Frostings and cakes
- Maraschino cherries
- Protein shakes
- Oral medicines and dietary supplements
Interestingly, while Red Dye No. 3 was banned in cosmetics and topical drugs in 1990 due to cancer concerns, it remained legal in food products—until now.
Why Is It Being Banned?
The FDA recently banned Red Dye No. 3 in response to evidence from animal studies. Research demonstrated that male lab rats exposed to high doses of the dye developed cancerous tumors, particularly thyroid tumors.
Under the Federal Food, Drug, and Cosmetic Act, the FDA cannot permit the use of any additive proven to cause cancer in humans or animals. Although no direct link to human cancer has been established, the potential risk raised enough concern to prompt action.
Why Is It Difficult to Prove Cancer Risk in Humans?
Determining whether Red Dye No. 3 causes cancer in humans is exceptionally challenging. Ethical considerations prevent researchers from conducting controlled studies that expose participants to potentially harmful substances. Additionally, many people consume Red Dye No. 3 unknowingly and in varying amounts, making it hard to study its long-term effects on human populations.
Despite the absence of definitive human data, experts agree that the risk, combined with the lack of any nutritional benefit, makes the continued use of this dye unjustifiable.
What Happens Next?
The FDA has set a timeline for phasing out Red Dye No. 3:
- Food manufacturers must remove the additive by January 15, 2027.
- Drug manufacturers must comply by January 18, 2028.
However, during this transition, products containing Red Dye No. 3 will still be available on store shelves. In fact, a search of the U.S. Department of Agriculture’s food database found that over 9,000 food items currently contain this additive.
What Can Consumers Do?
While waiting for the ban to take full effect, consumers can take steps to avoid Red Dye No. 3:
- Read Food Labels: Look for terms like:
- FD&C Red No. 3
- FD&C Red 3
- Red 3
- Choose Naturally Colored Alternatives: Many manufacturers are switching to natural dyes made from fruits, vegetables, or spices.
- Be Mindful of Medications: Check ingredient lists on over-the-counter and prescription medicines, especially those in liquid or chewable forms.
What About Cancer Risks?
While the evidence linking Red Dye No. 3 to cancer in humans is inconclusive, many experts argue that eliminating even a theoretical cancer risk is worth the effort—especially since the dye serves no essential purpose.
Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI), aptly summarized this sentiment: “When the function is purely aesthetic, why accept any cancer risk?”
Global Perspective
It’s worth noting that many countries, including Japan, Australia, and members of the European Union, banned or restricted Red Dye No. 3 years ago. California followed suit in 2023, and 10 other U.S. states have introduced similar legislation.
The banning of Red Dye No. 3 is a positive step toward safer food and drug products. While the risks to humans remain uncertain, the precautionary principle suggests that reducing exposure to unnecessary synthetic chemicals is a wise choice. Patients, caregivers, and healthcare providers should stay informed, advocate for cleaner labeling practices, and support the shift toward natural alternatives.
By reading labels and choosing products without Red Dye No. 3, consumers can take proactive steps to protect their health—and that of their loved ones.
About the author
Dr. Sajeve Thomas is a distinguished medical professional and a compassionate guide in the field of oncology. With over a decade of dedicated experience as a board-certified medical oncologist/internal medicine specialist, Dr. Thomas has become a trusted expert in the treatment of melanoma, sarcoma, and gastrointestinal conditions. He brings a wealth of expertise to the complex and challenging world of oncology.