March 04, 2025
The U.S. Food and Drug Administration (FDA) has officially announced the revocation of Red No. 3 (FD&C Red No. 3) as a color additive in food and ingested drugs, marking a major regulatory shift after decades of concern over its potential health risks. This decision aligns with growing scientific evidence linking the dye to cancer in laboratory animals and reinforces the FDA’s commitment to consumer safety.
What Is Red No. 3?
Red No. 3, also known as Erythrosine, is a synthetic dye that has been widely used in:
Candies and fruit snacks (e.g., jelly beans, fruit chews)
Baked goods and frostings
Certain beverages
Orally ingested drugs, such as coated pills
While Red No. 3 was already banned in cosmetics and externally applied drugs in 1990, it remained approved for use in food and ingested medications—until now.
Why Is the FDA Banning Red No. 3?
The FDA’s decision is based on longstanding research showing that high doses of Red No. 3 caused thyroid cancer in laboratory animals. Under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is prohibited from approving any additive shown to cause cancer in humans or animals.
In October 2023, a petition filed by the Center for Science in the Public Interest (CSPI) urged the FDA to remove the dye from food and drugs, citing growing health concerns and existing scientific evidence. The FDA’s recent ruling acknowledges the risks and ensures regulatory consistency by extending the existing ban on Red No. 3 in cosmetics to food and ingested drugs as well.
Key Findings on Red No. 3’s Health Risks:
Animal Studies: Laboratory research has shown that high doses of Red No. 3 caused thyroid tumors in rats, raising concerns about its potential cancer risk in humans.
Behavioral Concerns: Some studies suggest that synthetic dyes, including Red No. 3, may contribute to hyperactivity in children, although more research is needed.
Regulatory Precedent: The FDA banned Red No. 3 in cosmetics and externally applied drugs in 1990—this new ruling now extends the prohibition to ingested products.
For more details, read the FDA’s official statement on the ban: FDA.gov.
What This Means for Food and Drug Manufacturers
With this ruling, companies using Red No. 3 in food and ingested drugs must reformulate their products to comply with the updated FDA regulations. The agency is expected to provide guidance and a transition period to allow manufacturers time to phase out the dye and find suitable alternatives.
Alternatives to Red No. 3:
Natural Colorants: Beet juice extract, paprika, and anthocyanins from fruits and vegetables are safe, plant-based alternatives.
Other FDA-Approved Dyes: Red No. 40 (Allura Red) remains an approved alternative for some applications, though it also faces scrutiny.
What Should Consumers Do?
Consumers concerned about synthetic dyes can take proactive steps by:
Checking ingredient labels for "Red No. 3" or "Erythrosine."
Choosing natural alternatives that use fruit- or vegetable-based colorants.
Following FDA updates to stay informed about regulatory changes.
Final Thoughts
The FDA’s revocation of Red No. 3 in food and ingested drugs marks a significant step in consumer safety, reinforcing the agency’s commitment to removing potentially harmful additives from the market. While this change may require adjustments for food and pharmaceutical manufacturers, it ultimately prioritizes public health.
For businesses navigating these regulatory updates, compliance is key. If your company needs guidance on ensuring FDA compliance, reach out to Provision Consulting Group today.
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