SEVERE — -15 pts

Red 3 (Erythrosine)

Flags: F-R04, D-R04

Also known as: Erythrosine, FD&C Red No. 3, E127, CI 45430

Kids Food & SnacksKids Beverages

What it is

Red 3 is a synthetic cherry-pink dye used in candy, popsicles, cake decorations, and some beverages. Unlike other red dyes, it produces a distinctly bright, almost fluorescent pink-red color.

SEVERE

FDA revoked authorization for Red 3 in January 2025 after decades of evidence that it causes thyroid cancer in laboratory animals. This was one of the longest-delayed regulatory actions in FDA history; the dye had been banned in cosmetics and externally applied drugs since 1990 but was still permitted in food until 2025.

Why it matters

Thyroid carcinogenesis: causes thyroid tumors in male rats via a well-characterized hormonal mechanism
FDA revoked food use authorization effective January 2025
Previously banned in cosmetics and external drugs (1990) under the Delaney Clause
Behavioral effects similar to other synthetic dyes (AAP 2018)

The research

FDA Revokes Authorization for Red No. 3

U.S. Food and Drug Administration. FDA, 2025. Federal Register notice revoking 21 CFR listings for FD&C Red No. 3 [Source]

"FDA revoked authorization based on the Delaney Clause after confirming Red 3 causes cancer in laboratory animals"

Who should care most

All consumers, particularly children who consume candy and flavored products with high dye content. Products manufactured before the ban may still be on shelves.

How other countries handle it

Country	Status
United States	Authorization REVOKED (January 2025). Manufacturers given until January 2027 (food) and January 2028 (ingested drugs) to reformulate.
European Union	Permitted with restrictions (E127). Allowed only in cocktail cherries, candied cherries, and Bigarreaux cherries.
Canada	Permitted.
Australia	Permitted as E127 with ADI limits.

Sources

FDA Revokes Authorization for Red No. 3. U.S. Food and Drug Administration. FDA, 2025. Federal Register notice revoking 21 CFR listings for FD&C Red No. 3. https://www.fda.gov/food/food-additives-petitions/fdc-red-no-3

For informational purposes only. Not medical or dietary advice. Consult your pediatrician. Data current as of March 24, 2026.