FDA Bans Red Dye No. 3 from Foods
U.S. regulators on Wednesday banned the dye called Red 3 from the nation’s food supply, nearly 35 years after it was barred from cosmetics because of potential cancer risk.
Background
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some candies, snack cakes, and maraschino cherries a bright red hue.
Reason for Ban
The agency said it was taking the action as a “matter of law” because some studies have found that the dye caused cancer in lab rats. Officials cited a statute known as the Delaney Clause, which requires FDA to ban any additive found to cause cancer in people or animals.
History of Red 3
The dye is known as erythrosine, FD&C Red No. 3 or Red 3. The ban removes it from the list of approved color additives in foods, dietary supplements, and oral medicines, such as cough syrups. More than three decades ago, the FDA declined to authorize use of Red 3 in cosmetics and externally applied drugs because a study showed it caused cancer when eaten by rats.
Jones’ Statement
“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
Timeline for Compliance
Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same. Other countries still allow for certain uses of the dye, but imported foods must meet the new U.S. requirement.
Reaction from Consumer Advocates
Consumer advocates praised the decision.
“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” said Dr. Peter Lurie, director of the group Center for Science in the Public Interest, which led the petition effort.
Concerns about Legal Challenges
It’s not clear whether the ban will face legal challenges from food manufacturers because evidence hasn’t determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that’s a risk.
Conclusion
The ban on Red 3 is a significant step towards protecting public health, and it is essential to ensure that all food products meet the highest standards of safety and quality. The FDA’s decision to remove Red 3 from the list of approved color additives in foods, dietary supplements, and oral medicines is a testament to its commitment to ensuring that the food supply is safe for consumers.
FAQs
Q: What is Red 3?
A: Red 3 is a synthetic food dye used to give foods a bright red color.
Q: Why is Red 3 being banned?
A: The FDA has banned Red 3 due to its potential to cause cancer in lab rats.
Q: What is the timeline for compliance with the ban?
A: Food manufacturers have until January 2027 to remove Red 3 from their products, while makers of ingested drugs have until January 2028 to do the same.
Q: Will other countries ban Red 3?
A: Some countries, such as Europe, Australia, and New Zealand, have already banned Red 3, except in certain cases.
