Introduction to the FDA Ban on Red Dye No. 3

The FDA announced in January that it would ban a dye called red dye No. 3 in food and ingested drugs, citing a 1987 study on rats to support its action. The industry-funded study, led by Virginia toxicologist Joseph Borzelleca, found that the petroleum-derived food coloring doesn’t cause cancer in humans.

Background on the Study

Borzelleca, 94, a professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, said that his research found the dye is not a problem for humans. “If I thought there was a problem, I would have stated it in the paper,” he told KFF Health News after the FDA’s announcement. The study was published in a scientific journal, Food and Chemical Toxicology, and examined the data collected by Borzelleca’s team.

FDA’s Decision and Reaction

The FDA examined the data and reached its own conclusion: that the dye caused cancer in male lab rats. In 1990, the FDA cited the study in banning Red 3 in cosmetics. In 1992, the FDA said it wanted to revoke approval of Red 3 in food and drugs, but the agency didn’t act at the time, citing a lack of resources. More than 30 years later, after a renewed push by consumer advocates, the Biden administration announced the ban in its last days in power.

Reaction from Consumer Advocacy Groups and Industry

Consumer advocacy groups cheered the Red 3 ban, even as the FDA said there is no evidence that the dye is dangerous to people. The International Association of Color Manufacturers says Red 3 is safe in the tiny levels typically consumed by humans. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, which petitioned the FDA for a ban, said that a federal regulation known as the Delaney Clause prohibits any ingredient that causes cancer in animals from being included in foods.

Global Regulations on Red Dye No. 3

The European Union, Australia, and Japan are among the locations that already ban the chemical in foods. The EU’s ban also cites hyperactivity in children. In October 2023, California became the first state to ban Red 3 in food starting in 2027, superseding the FDA’s earlier rule allowing small amounts in foods as a color additive. Some food manufacturers have already reformulated products to remove Red 3, using alternatives such as beet juice, carmine, or pigments from foods like purple sweet potato, radish, and red cabbage.

Impact on the Food Industry

Marty Makary, Trump’s nominee to lead the FDA, said at his Senate confirmation hearing on March 6 that he is concerned about whether food additives such as Red 3 harm children.
Dr. Martin Makary, President Donald Trump’s nominee to lead the Food and Drug Administration testifies during his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions Committee at the Dirksen Senate Office Building on March 06, 2025 in Washington, DC. Dr. Makary is a cancer surgeon, researcher at Johns Hopkins University, and has also been a Fox News commentator. (Photo by Kayla Bartkowski/Getty Images)

Conclusion

The FDA’s decision to ban Red 3 in food and ingested drugs has been met with both support and criticism. While consumer advocacy groups have cheered the ban, the food industry and some scientists have questioned the evidence behind the decision. As the food industry adapts to the new regulation, it remains to be seen how the ban will impact public health and the use of artificial food dyes in the future.

FAQs

Q: What is Red Dye No. 3?
A: Red Dye No. 3 is a petroleum-derived food coloring that has been used in foods and ingested drugs.
Q: Why did the FDA ban Red Dye No. 3?
A: The FDA banned Red Dye No. 3 due to concerns that it may cause cancer in animals, citing a 1987 study on rats.
Q: Is Red Dye No. 3 safe for human consumption?
A: The FDA says there is no evidence that Red Dye No. 3 is dangerous to people, but some scientists and consumer advocacy groups have raised concerns about its potential health impacts.
Q: What alternatives are being used in place of Red Dye No. 3?
A: Some food manufacturers are using alternatives such as beet juice, carmine, or pigments from foods like purple sweet potato, radish, and red cabbage.