Ball-and-stick model of erythrosine (Red Dye No. 3), the synthetic compound recently banned by the FDA due to its links to cancer in animal studies. This chemical structure highlights its petroleum-based origins.

The Food and Drug Administration (FDA) has announced a nationwide ban on Red Dye No. 3, a synthetic color additive widely used in foods, beverages, and medications. This decision follows decades of advocacy from consumer groups concerned about potential health risks, particularly its link to cancer in animals.

The dye, also known as Erythrosine, has long been a staple in products such as candies, baked goods, frostings, and certain medications. However, studies dating back to the 1980s have raised alarms over its potential to cause tumors in male laboratory rats exposed to high doses. While the evidence does not directly link the dye to cancer in humans, the FDA acted under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This provision mandates the agency to ban any additive found to induce cancer in humans or animals, regardless of the mechanism or dosage.

A Timeline for Transition

Food manufacturers must phase out the use of Red Dye No. 3 by January 15, 2027, while pharmaceutical companies have an additional year, until January 18, 2028, to reformulate their products. This extended timeline aims to allow industries sufficient time to adjust their production processes and find suitable alternatives.

Jim Jones, the FDA’s Deputy Director for Human Foods, emphasized the scientific foundation of the decision, stating, “Research shows that Red Dye No. 3 has caused cancer in laboratory animals at high exposure levels, even though the same mechanism does not apply to humans.”

Advocacy and Industry Response

Organizations like the Center for Science in the Public Interest (CSPI), which filed the 2022 petition urging the FDA to act, hailed the move as long overdue. Dr. Peter Lurie, president of the CSPI, expressed relief, noting, “This decision corrects a regulatory failure that allowed a potentially hazardous dye to persist in the American food supply for far too long.”

Conversely, the International Association of Color Manufacturers has urged caution in interpreting the risks. The group highlighted that animal studies often involve doses far exceeding typical human consumption and stressed that this may not translate to real-world effects on people.

The National Confectioners Association, representing candy makers, pledged to comply with the FDA’s regulations. A spokesperson emphasized that the industry prioritizes safety and adheres to science-based standards.

Global and Historical Context

This ban aligns the United States with other regions, including the European Union, Australia, and Japan, where Red Dye No. 3 has already faced restrictions or prohibitions. Notably, the FDA banned its use in cosmetics and topical medications as early as 1990 but had allowed it to remain in food and oral drugs—a regulatory inconsistency often criticized by health advocates.

In recent years, individual states like California have also acted independently to restrict the use of Red Dye No. 3. This growing momentum reflects a broader shift toward scrutinizing artificial additives in the food supply.

Broader Implications

With President-elect Donald Trump set to take office soon, there is speculation about further regulatory changes. His incoming Health and Human Services Secretary, Robert F. Kennedy Jr., has previously expressed interest in removing other artificial dyes from the market, signaling a potential push for even stricter oversight of food additives.

Although some manufacturers have already begun phasing out artificial dyes, consumer awareness remains crucial. Experts encourage shoppers to check product labels for additives like Red Dye No. 3, which may appear as “FD&C Red No. 3,” “FD&C Red 3,” or simply “Red 3.”

As the FDA’s decision marks a turning point in addressing artificial dyes in the U.S. food system, it reinforces growing consumer demand for transparency and safer alternatives in everyday products.

Image is licensed under the Creative Commons CC0 1.0 Universal Public Domain Dedication and was created by MarinaVladivostok.