More than three decades after scientific findings linked red dye No. 3 to cancer in animals, the U.S. Food and Drug Administration (FDA) has officially banned its use in food, beverages, and ingested drugs. This move, announced Wednesday, addresses mounting concerns about the additive's safety and aligns with advocacy efforts and state-level legislation.

What is Red Dye No. 3?

Red dye No. 3, chemically known as erythrosine, is a synthetic color additive derived from petroleum. It imparts a bright cherry-red hue to foods, beverages, and some medications.

  • Common Uses:
    • Candy
    • Beverages
    • Certain pharmaceuticals
  • Chemical Identity:
    • Synthetic additive
    • Composed of organic compounds from petroleum derivatives

Timeline of Events

Date Event
1969 Initial FDA approval of red dye No. 3.
1990 FDA banned red dye No. 3 in cosmetics and topical drugs under the Delaney Clause.
2022 Petition filed by advocacy groups, including the Center for Science in the Public Interest (CSPI).
2023 California banned red dye No. 3 in food.
2024 Just Born, the maker of PEEPS, phased out red dye No. 3.
2027-2028 FDA deadlines for reformulating foods (2027) and drugs (2028).

Why the Ban Now?

The Delaney Clause of the Federal Food, Drug, and Cosmetic Act prohibits the FDA from approving additives that cause cancer in animals or humans when ingested. While red dye No. 3 has long been linked to cancer in lab rats, its mechanism was deemed irrelevant to humans, allowing its continued use in food.

Key Factors Driving the Ban:

  1. Advocacy Efforts:
    • Led by CSPI, Environmental Working Group, and others.
    • Highlighted long-standing concerns about carcinogenicity.
  2. Legislative Pressure:
    • States like California and over ten others introduced bans or restrictions.
  3. Scientific Re-evaluation:
    • Studies indicated potential health risks, including behavioral impacts in children.

Scientific Findings

  • Animal Studies:
    • High doses of red dye No. 3 caused cancer in male rats.
  • Human Impact:
    • No direct studies confirm cancer links in humans, but the Delaney Clause necessitated precautionary measures.

Behavioral Concerns:

  • 2021 California Study:
    • Found red dye No. 3 may contribute to behavioral and attention issues in children.
  • Immune and Brain Health Risks:
    • Studies suggested immune-system tumors in mice and potential harm to children’s brain health.

Industry Response

Compliance Deadlines:

  • Food: Manufacturers have until January 15, 2027.
  • Drugs: Reformulations required by January 18, 2028.

Current Actions by Companies:

  • Ferrara (Brach’s Candies): Began phasing out red dye No. 3 in 2023; fewer than 10% of its products now use it.
  • Just Born (PEEPS): Eliminated red dye No. 3 after Easter 2024.

Alternatives:

  • Red Dye No. 40: Used as a substitute but has its own safety concerns, including links to behavioral issues and benzene contamination.

Global Context

European Union:

  • Banned red dye No. 3 in 1994 (except for certain maraschino cherry products).

Precautionary Principle:

  • The EU adopts stricter food safety measures compared to the FDA’s historical regulatory paradox.

Consumer Health and Safety

Steps to Avoid Red Dye No. 3:

  1. Read Ingredient Labels:
    • Look for “red dye No. 3,” “red 3,” or “FD&C Red #3.”
  2. Avoid Ultra-Processed Foods:
    • Red dye No. 3 is primarily found in foods that cannot be made at home.
  3. Check Medications:
    • Search for dye-free options in the “inactive ingredients” section.

CSPI Recommendations:

  • Avoid all numbered food dyes, including yellow No. 5 and red No. 40.

Criticism of FDA Delays

Experts and advocacy groups have criticized the FDA’s delayed response to known safety concerns:

  • Dr. Jennifer Pomeranz (NYU):
    • Called the delay in banning red dye No. 3 “irrational.”
  • Dr. Jerold Mande (Harvard):
    • Criticized the influence of the food industry in stalling regulation.

Conclusion

The FDA’s decision to ban red dye No. 3 marks a significant, albeit delayed, step toward improving consumer health. This action underscores the importance of robust regulatory frameworks and vigilance in protecting public health against harmful additives.

For further guidance, consumers are encouraged to:

  • Be proactive about reading food and medication labels.
  • Support legislation aimed at improving food safety standards.
  • Advocate for increased funding and transparency in FDA operations.

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Sources:

  • FDA announcements
  • CSPI research
  • California Office of Environmental Health Hazard Assessment studies