On Wednesday, the Food and Drug Administration (FDA) declared a significant change in its regulations, prohibiting the use of artificial Red No. 3 in food and ingested drugs. This decision follows a petition filed in 2022 by advocates who raised concerns about the additive’s potential links to cancer and behavioral issues in children. Manufacturers have been given until early 2027 for food products and early 2028 for drugs to comply with this new directive.

A Step Toward Safer Consumption: Why Banning Red No. 3 Matters

Understanding the Additive: What Is Red No. 3?

Red No. 3, also known as erythrosine, is a petroleum-based synthetic dye that imparts a vivid cherry-red hue to various foods and beverages. Historically, it has found widespread application in candies, cakes, frozen desserts, frostings, and even certain medications. The Environmental Working Group reports that over 3,000 products contain this controversial additive. Despite its popularity, Red No. 3 was banned from cosmetics in the U.S. in 1990 due to carcinogenic effects observed in lab rats at high doses. However, it remained one of nine synthetic dyes approved for food products until now.The FDA's recent action marks a turning point, reflecting growing public health concerns. The remaining eight approved dyes—Blue No. 1, Blue No. 2, Green No. 3, Orange B, Red 40, Yellow 5, Yellow 6, and Citrus Red—are still permitted but face increasing scrutiny. The shift highlights an ongoing debate about the safety of artificial coloring agents in everyday items.

Reasons Behind the Ban: Cancer Concerns and Beyond

The ban on Red No. 3 stems from a petition filed in 2022 that cited two studies showing cancer in male lab rats exposed to high levels of the dye. Although the FDA maintains that these effects do not occur in humans and exposure levels are typically much lower, the precautionary principle guided their decision. The agency emphasized that while other animal and human studies did not replicate these findings, the potential risks warranted action.Moreover, public health advocates argue that the additive may contribute to behavioral issues in children, particularly those with ADHD. While definitive evidence remains elusive, the precautionary approach aims to protect vulnerable populations. The FDA's decision underscores a commitment to consumer safety, aligning with broader trends toward minimizing exposure to potentially harmful substances.

State-Level Initiatives: California Leads the Charge

California became a trailblazer in 2023 by banning the manufacture, sale, or distribution of four food additives, including Red No. 3. In a separate act passed in 2024, the state moved to eliminate six of the nine FDA-approved artificial food dyes from public school meals by 2027. Notably, Red No. 3 was excluded from this particular bill. Nevertheless, California's actions catalyzed similar efforts in other states like Illinois and New York.Over the past decade, bills targeting Red No. 3 and other food dyes have emerged in several states, including Maryland, Missouri, New Jersey, Pennsylvania, Rhode Island, South Dakota, Washington, and West Virginia. These legislative moves reflect growing awareness and concern about the long-term health impacts of artificial additives. The trend indicates a nationwide shift toward stricter regulation and greater transparency in food labeling.

Global Perspective: Bans and Restrictions Abroad

The European Union, Australia, and New Zealand have already implemented bans on Red No. 3, underscoring international consensus on its potential risks. These regions have taken proactive steps to safeguard public health, often leading the way in food safety regulations. The FDA's recent decision aligns with global trends, signaling a coordinated effort to address shared health concerns.In conclusion, the FDA's ban on Red No. 3 represents a significant milestone in food safety. By phasing out this controversial additive, regulators aim to mitigate potential health risks and promote safer consumption practices. As more states and countries adopt similar measures, the future of artificial food coloring faces unprecedented scrutiny and reform.