FDA bans Red 3 dye from food and drugs — a scientist explains the artificial color’s health risks and long history
Over 35 years after the first study linking Red 3 to thyroid cancer in rats was published, the US is beginning to wean it out of foods and drugs.
By , Professor and Associate Dean for Research, College of Pharmacy, University of South Carolina
Red 3 — also called FD&C Red №3, erythrosine or E127 — has been widely used in food, cosmetics and pharmaceuticals since its . You’ve likely encountered Red 3 before. It’s a common additive to many candies, beverages, baked goods, cereals, maraschino cherries and gelatin desserts, as well as certain medications, syrups and cosmetics.
However, mounting scientific evidence suggests that consuming Red 3 poses significant health risks. These risks prompted in food in 2023 and the its use in both food and pharmaceuticals nationwide on Jan. 15, 2025.
As a researcher studying , I investigate how synthetic food dyes affect human health. Stricter regulations reflect growing concerns over the negative physiological effects of Red 3 and other synthetic dyes on your body, including causing cancer.
Health risks of Red 3
Over the past 35 years, an has identified the negative health effects of Red 3. While researchers haven’t yet established a direct link between Red 3 and cancer in people, substantial evidence from animal studies points to its carcinogenic potential.
First, Red 3 through several mechanisms. It inhibits the thyroid gland’s ability to , a key component for synthesizing thyroid hormones, and blocks an for converting one thyroid hormone to another, contributing to . Along with other , Red 3 increases the risk of thyroid-related disorders.
Second, Red 3 may promote thyroid tumor formation. to Red 3 observed enlarged tumorous thyroid glands and abnormalities in hormone regulation.
Third, Red 3 can have toxic effects on the brain in multiple ways. Rat studies have found that this synthetic dye , which damages tissues, and reduces the antioxidants that control oxidative stress, impairing communication between neurons. Studies in rodents also found that Red 3 that leads to neuronal damage and dysfunction. Additionally, Red 3 may linked to neurodegenerative conditions like Alzheimer’s disease and worsen those conditions.
Regulatory momentum
Red 3 first faced scrutiny in the 1980s when several animal studies . This led to its in the U.S., although its use in food persisted under industry pressure. While the restricted the use of Red 3 to only certain types of processed cherries in 1994, the U.S. has lagged behind.
in foods, effective in 2027, reignited debate on Red 3 and its link to cancer and spurred to advocate for federal action.
This debate culminated in the FDA’s . While the FDA cites no direct evidence of Red 3’s carcinogenic effect in people, it acknowledges that animal studies provide sufficient basis for regulatory action. The FDA’s decision aligns with the of the Federal Food, Drug and Cosmetic Act, mandating a ban on additives shown to cause cancer in humans or animals.
Notably, it took over 35 years from the initial findings of thyroid cancer in rodents to the eventual ban in 2025.
A path forward
The progression from Red 3’s approval to its prohibition highlights the conflict between industrial interests and public health. Continued vigilance over Red 3 could help the nation prioritize consumer safety.
Under the FDA’s mandate, manufacturers must to leave out Red 3 by January 2027 and January 2028, respectively. While some countries still permit use of Red 3, U.S. imports must meet domestic safety standards. Harmonizing global standards on regulating and evaluating synthetic dyes is essential to protect consumer health.
Several companies selling ultra-processed foods have begun the shift away from synthetic dyes. In 2016, to remove all artificial colors from its human food products over a five-year period. In 2024, that it would eliminate artificial colors and flavors from its products.
Consumers can protect themselves from Red 3 exposure by reading ingredient labels for “FD&C Red №3” or “E127” and choosing products that use natural dyes. Preparing homemade foods with natural color alternatives like beet juice or turmeric is another option. Supporting dye-free brands and staying informed about regulatory changes can further reduce your exposure while promoting safer food practices.
Ongoing research and policy reforms focused on public safety could help ensure that food additives like Red 3 no longer put consumer health at risk.
This article is from The Conversation, an independent nonprofit news organization dedicated to sharing the latest research from experts, written by the experts themselves. or subscribe to our weekly .
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Lorne J. Hofseth receives funding from the National Institutes of Health.
