FDA Bans Red Dye No. 3 in Food and Drugs Over Cancer Risk

The U.S. Food and Drug Administration (FDA) has issued a nationwide ban on the use of red dye No. 3 in food, beverages, and ingestible drugs due to its links to cancer in animal studies. The ban, effective January 2027, follows decades of scrutiny and aligns with global efforts to remove harmful additives from consumer products.

Why Is Red Dye No. 3 Being Banned?

• Health Concerns: Studies dating back to the 1990s identified red dye No. 3 as a potential carcinogen, leading to its ban in cosmetics and topical drugs.
• Cancer Link: Animal studies have shown that high doses of the dye can cause thyroid tumors and cancer.
• Global Restrictions: The dye is already banned or restricted in many countries, including those in the European Union, Australia, and Japan.

Despite these findings, red dye No. 3 is still present in numerous U.S. products, from candies and baked goods to over-the-counter medications and even toothpaste.

Public Advocacy and FDA Action

Years of lobbying by health organizations, including the Center for Science in the Public Interest (CSPI) and the Environmental Working Group (EWG), culminated in this decision. These groups pointed to research showing harmful effects, particularly for children, who are among the largest consumers of artificially colored foods.

Kelsey Costa, a registered dietitian, noted that under the Delaney Clause, the FDA is prohibited from approving additives known to cause cancer. “By this standard, red dye No. 3 should have been banned decades ago,” she stated.

Alternatives to Red Dye No. 3

Manufacturers will need to replace the synthetic dye with safer alternatives. Experts suggest natural, plant-based colorants such as:

• Beet juice: Provides a deep red hue.
• Hibiscus or elderberry extracts: Rich in antioxidants.
• Annatto or paprika extracts: Known for red-orange tones.
• Anthocyanins from red cabbage or radish: Popular in clean-label products.

While these options may not replicate the intensity of synthetic dyes, they offer added nutritional benefits without health risks.

Broader Implications for Public Health

The FDA’s move mirrors trends in states like California, where legislation banning red dye No. 3 and other harmful additives has spurred similar federal action. Registered dietitian Katie Sanger called the ban “a step toward improving public health” by reducing exposure to toxic substances linked to chronic diseases.

Takeaway

The FDA’s upcoming ban on red dye No. 3 marks a significant shift in U.S. food safety standards. While overdue, the decision underscores the importance of prioritizing consumer health over industrial convenience. By 2027, manufacturers must find safer alternatives, potentially ushering in a new era of cleaner, more health-conscious products.