
FDA Bans Red Dye No. 3: What You Need to Know
This decision comes over three decades after initial concerns were raised linking the synthetic additive to cancer in animals.
Also known as erythrosine, red dye No. 3 is a petroleum-based colorant widely used to achieve a vibrant cherry-red hue in various products. While previously banned in cosmetics in 1990 under the FDA’s Delaney Clause, its use in food persisted despite mounting evidence of potential health risks.
What Prompted the Ban?
Advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, have long pushed for the prohibition, citing links to carcinogenic effects in animal studies. Following California’s ban of the additive in 2023, federal regulators took action, announcing a phased removal timeline for manufacturers:
- Food and beverage products: Reformulation required by January 15, 2027.
- Ingested drugs: Compliance deadline set for January 18, 2028.
Impact on Manufacturers and Consumers
Many major brands, including Ferrara (makers of Brach’s candies) and Just Born (known for PEEPS), had already begun phasing out red dye No. 3. Alternatives like red dye No. 40 have been adopted, though this additive has its own controversies, including links to behavioral issues in children and other potential health concerns.
Ken Cook, president of the Environmental Working Group, lauded the FDA’s decision, calling it a “monumental victory for consumer health.” However, experts note that more regulatory action is needed to address other harmful additives still in circulation.
The Science Behind the Ban
The Delaney Clause, a provision of the Federal Food, Drug, and Cosmetic Act, prohibits additives linked to cancer in humans or animals from being approved for ingestion. Research in the 1980s found high doses of red dye No. 3 caused cancer in rats, yet its use in food remained due to legal and scientific loopholes.
While no direct evidence has linked the dye to cancer in humans, experts argue that precautionary measures are warranted given the risks observed in animal studies. Additionally, a 2021 California study linked the additive to behavioral issues in children, raising further concerns.
How to Avoid Red Dye No. 3
Until the ban is fully implemented, consumers can take steps to avoid red dye No. 3 by checking ingredient labels. The dye is listed under various names, including “red 3” and “FD&C Red No. 3.” Opting for minimally processed foods and dye-free medications can also help reduce exposure.
The FDA’s ruling is a step toward aligning US regulations with those of the European Union, which banned red dye No. 3 in 1994. The decision reflects growing awareness of food safety and the need for stronger protections for public health.
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