What is Red 3 (erythrosine)? FDA status and safety context

Red 3, also called erythrosine or FD&C Red No. 3, is a synthetic dye used for bright pink-red color. Its main regulatory issue comes from rodent thyroid-tumor findings at high doses. FDA revoked its approval for foods and ingested drugs in 2025, and manufacturers now have until 2027 to reformulate. For consumers, that means Red 3 is still relevant on current labels, but its long-term use in US foods is ending.

Aliases / Common Names: FD&C Red No. 3; Erythrosine; Erythrosine B; C.I. Food Red 14; INS 127; E 127. It is a cherry-red xanthene dye containing iodine. Regulatory Status & Exposure: First approved in 1969, Red 3 was widely used as a certified food color in the U.S. for decades. The FDA set no formal Acceptable Daily Intake (ADI) but allows use “consistent with good manufacturing practice,” resulting in low typical dietary levels. In 1990, after animal studies showed thyroid tumors, the FDA banned Red 3 in cosmetics and topical drugs. However, it stayed permitted in foods and ingested medicines until recently. A coalition of health groups petitioned FDA in 2022 to delist Red 3 from foods and supplements. Citing the Delaney Clause (which prohibits additives that cause cancer in any species), the FDA announced in January 2025 that Red 3’s authorization for foods and oral drugs will be revoked. Manufacturers must reformulate by 2027. In Europe, regulators set a very low ADI of 0.1 mg/kg body weight and restrict erythrosine’s use to only cocktail and candied cherries. Canada and some other regions likewise prohibit or limit Red 3 in foods. These measures reflect an effort to minimize intake. Notably, expert evaluations indicate that typical human exposure to Red 3 (from occasional colored treats) is far below the ADI or any toxic threshold. JECFA and EFSA reviews concluded that normal dietary use is unlikely to exceed safe levels. Still, out of caution, jurisdictions like California have passed laws to ban Red 3 in foods altogether by 2027. Technical Evidence: Red 3’s main safety concern comes from animal data. In rodent studies, extremely high doses of erythrosine disrupted the rats’ thyroid-pituitary axis, leading to chronically elevated thyroid-stimulating hormone (TSH) and, in a few long-term studies, benign thyroid tumors. The mechanism involves the dye (which contains iodine) inhibiting the conversion of thyroid hormone T4 to T3 in the liver, causing the rat’s thyroid gland to be overstimulated by TSH. Importantly, this effect is considered species-specific: rats are uniquely sensitive to TSH-mediated thyroid growth, whereas humans have different thyroid physiology (e.g. humans have thyroid-binding globulin and a longer T4 half-life) that makes us less prone to such tumors. Regulatory scientists have noted that erythrosine does not directly damage DNA and is not genotoxic. Aside from the thyroid findings, toxicologists report that Red 3 has low overall toxicity: it’s poorly absorbed in the gut and is mostly excreted unchanged, shows no significant effects on reproduction or development, and did not cause cancers in other organs or in other test species at the doses tested. The “weight-of-evidence indicates that it is not carcinogenic” to humans at expected exposure levels. Nonetheless, because even rodent tumors trigger legal concern under U.S. law, Red 3 has been deemed unsafe for food use. Some research has also explored behavioral and endocrine effects. Synthetic dyes as a class have been associated with hyperactivity in a subset of children, though Red 3 specifically is less studied for this effect. There have been rare reports of allergic or intolerance reactions at high doses in sensitive individuals, but such cases are uncommon. Overall, the consensus of major reviews (FDA, EFSA, JECFA) is that while Red 3 can cause harm in lab conditions, it is unlikely to pose a significant risk at the much smaller amounts used in foods. The recent regulatory actions are largely precautionary and driven by legal mandates rather than new evidence of widespread human harm. Fast-Food Context: In U.S. fast food, Red 3 has mainly been used to impart a vivid red or pink hue to sweets and treats. For example, the classic “cherry on top” of a sundae or milkshake – the red candied maraschino cherry – often owes its color to Red 3. It has also been used in certain dessert sauces, pink lemonade or punch drinks, and decorative icings or sprinkles on cookies and donuts commonly found in fast-food outlets. Some kids’ meal items and seasonal promotional treats (like red-colored candies in frozen desserts or holiday-themed pastries) have relied on Red 3 for their bright appearance. The FDA noted that Red 3 is not as ubiquitous as some other dyes (like Red 40), but it still appeared in a variety of confections, gelatin desserts, and snack foods that could be sold at quick-service restaurants or in vending machines. With the impending ban, fast-food chains and manufacturers are reformulating these items, either using alternative colorants (such as Red 40 or natural dyes) or removing the artificial coloring altogether. Consumers might see slightly less neon-pink cherries or candies in their fast-food desserts going forward. This change mainly affects visual appeal; no impact on flavor is expected. It serves as a case where regulatory caution is prompting the industry to seek safer or more natural coloring solutions for the same products. Sensitive Populations / Notes: Children are the most notable sensitive group for Red 3 and synthetic dyes in general. Kids often consume disproportionately more artificially-colored candies and sweets relative to their body weight, so their exposure can be higher on a mg/kg basis. Young children (especially under age 3) were identified in exposure assessments as having the highest per-body-weight intake of Red 3 from foods like candies and fruit-flavored snacks. This is one reason advocates pushed for its removal. Additionally, a small percentage of children with behavioral sensitivities may react adversely to artificial colors, experiencing worsened hyperactivity or attention issues. Parents of such children are often advised to limit synthetic dyes as a precaution. Individuals with thyroid disorders could theoretically be more vulnerable to large doses of iodine-containing additives like erythrosine, but the amounts in foods have been too low to have measurable effects on human thyroid function. Overall, for the average consumer, occasional ingestion of Red 3 at past levels was not known to cause any acute issues. The move to eliminate Red 3 is a preventative step aimed at reducing any long-term cancer risk, especially for lifelong high consumers of artificially colored foods (often children). As always, those who are extra cautious or chemically sensitive can look for natural color alternatives (like beet juice or annatto) on labels, since Red 3 will appear as “FD&C Red No. 3” or “Erythrosine” in ingredient lists until it is fully phased out.

We assign the Moderate Concern tier using published research, regulatory guidance, and PRūF’s additive taxonomy. Restaurant usage is derived from public ingredient disclosures and mapped to menu items where this additive appears. References last reviewed 2026-03-07.