FDA Bans FD&C Red No. 3: What It Means for Consumers and Industry

On January 15, 2025 the FDA banned the use of a synthetic food dye that has been used as a food additive for nearly 60 years. FD&C Red No. 3, also known as erythrosine, is a synthetic food dye that is responsible for the brilliant red colour in sweet treat favorites such as red velvet cake. Approved in the United States in the 1960s, it became a staple in products ranging from candy, cereals, and baked goods to cough syrups and toothpaste.

This artificial colorant belongs to a family of dyes regulated under the U.S. Food, Drug, and Cosmetic Act. Red 3 has long been listed on ingredient labels as “FD&C Red No. 3” and has been widely consumed by millions of people.

FD&C Red No. 3 has been in use for over 60 years. Despite early concerns over its safety, it remained legal in many food and drug applications in the U.S., even after it was banned in cosmetics and topical drugs in 1990 due to evidence of carcinogenicity in animal studies.

Red 3 is used in a variety of products across different sectors:

• Food & Beverages: Maraschino cherries, gelatin desserts, frostings, gum, snacks, and breakfast cereals
• Pharmaceuticals: Liquid medications, chewable tablets, and vitamin supplements
• Cosmetics (pre-1990 U.S. ban): Lipsticks, blushes, and other personal care items

Its appeal lies in its bright, stable color and low cost, making it a go-to additive for manufacturers for decades.

Safety Profile and Exposure Concerns

Red 3 has been a topic of regulatory debate for decades. Studies from the 1980s showed that high doses of the dye caused thyroid tumors in laboratory rats. While regulators initially dismissed the findings as not directly applicable to humans, advocacy groups and scientists have continued to raise red flags.

Key concerns include:

• Potential carcinogenic effects
• Widespread exposure among children, especially via candy and snacks
• Lack of updated, long-term human safety data

The Acceptable Daily Intake (ADI) for Red 3 set by regulatory bodies was based on older studies, and critics have argued it no longer reflects the best available science.

Why Did the FDA Ban FD&C Red No. 3?

In October 2023, the FDA announced it would prohibit the use of FD&C Red No. 3 in food and oral drug products, citing:

• New analysis of existing toxicology data
• A growing consensus that the 1985 studies demonstrating carcinogenic effects were more relevant to human health than previously thought
• Mounting pressure from consumer advocacy groups like the Center for Science in the Public Interest (CSPI), which petitioned for the ban in 2022

The FDA stated that Red 3 no longer meets the legal safety standard for food additives: “reasonable certainty of no harm.”

The ruling will give manufacturers a grace period to reformulate products and remove Red 3 from their ingredient lists. However, suppliers using this ingredient will certainly have to reformulate using alternatives including natural substances that have much different properties and shelf lives than Red 3.

Regulatory Implications in Canada

In Canada, FD&C Red No. 3 is still permitted under Health Canada’s List of Permitted Colouring Agents, but its use is limited to specific applications and concentrations. However, the recent FDA decision is likely to influence Canadian policy.

Health Canada has acknowledged the FDA’s ruling and stated it will review the available scientific data to determine if similar regulatory action is warranted.

Canadian companies that export to the U.S. will also face commercial pressure to eliminate Red 3, regardless of domestic regulation.

What Happens Next?

For consumers, this means that some familiar products, especially candy and children’s foods may look different in the near future. For manufacturers, it signals a major shift in formulation strategies, with many likely to turn to natural colorants such as beet juice or carmine. Overall this is consistent with North American consumer trends indicate a desire to be “chemical free”

For regulators worldwide, the FDA’s move may reignite discussions about modernizing safety evaluations for food additives, especially those approved decades ago under less rigorous standards.

Final Thoughts

The FDA’s ban on FD&C Red No. 3 reflects a growing trend toward precautionary regulation in the face of long-standing safety concerns. While Canada has yet to follow suit, the decision is a wake-up call for both consumers and industry players to re-evaluate the chemicals in our food.

Stay informed as regulatory landscapes evolve—and always check ingredient labels, especially on products marketed to children.

Keywords: FDA ban Red 3, FD&C Red No. 3, erythrosine, food dye safety, Canada food coloring regulations, artificial food dye cancer, food additive ban 2024 

To learn more about how this impacts your cosmetic business visit us on line at: https://mcs-associates.com/articles/

About MCS Associates Cosmetics Experts and how they can help you!

MCS Associates is an internationally respected regulatory affairs consulting group specializing in the North American marketplace for the past 40 years. Our niche is proving pragmatic, economic solutions to regulatory challenges. Our clients appreciate our responsiveness and passion to create solutions.

Our team of cosmetic experts can help by navigating requirements for your food product line. Specifically, they can support you in:

• Reformulation and development technical studies
• Product/Facility Registration
• GAP assessment of your current quality management system
• Establishing effective risk assessment strategies
• GMP Audits
• Training programs
• Communication with Regulatory Authorities
• Support release and stability program

Our Firm Can Benefit You with:

• Expertise: Our team comprises seasoned professionals with in-depth knowledge of cosmetic quality, safety, and regulatory compliance.
• Custom Solutions: We tailor our services to your specific needs, ensuring that our guidance aligns seamlessly with your business objectives.
• Timely Support: We understand the urgency of regulatory changes and provide timely support to facilitate a swift and compliant transition.

As a part of our core competencies, MCS Associates can help interpret guidance documents to determine the impact for clients involved in manufacturing, packaging, labeling, importation and distribution of cosmetics.

To learn more or request testing please contact us at: enquires@mcs-associates.com

#MCS Associates #MoCRA #ReenaGroup #RegulatoryAffairs #CosmeticConsultants #CosmeticQuality #CosmeticRegulations #CosmeticSafety #FDARegulations #CosmeticsCompliance #CleanBeauty #CosmeticsIndustry #CosmeticScience #BeautyRegulation #FDACompliance #BeautyIndustryNews