The Ban on Red Dye No. 3: What It Means for Compliance and Testing

Introduction

Red Dye No. 3, also known as erythrosine, has been a widely used synthetic colorant in food, beverages, and pharmaceuticals for decades. Its bright cherry-red hue made it a popular choice for manufacturers, but growing concerns over its safety have led to a significant regulatory shift. As of January 15, 2025, the U.S. Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3 in foods and ingested drugs, citing carcinogenicity concerns.

This article explores the history of the ban, its implications for manufacturers, compliance standards, and how AccuScience Laboratories is helping companies navigate the transition by offering advanced Red Dye No. 3 testing services.

The laboratory glassware and red liquid inside on white

Why Was Red Dye No. 3 Banned?

The concerns surrounding Red Dye No. 3 date back to the 1980s when research indicated a potential link between the dye and cancer. Studies on male rats exposed to high doses of Red Dye No. 3 showed an increased risk of thyroid cancer, triggering concerns about its safety for human consumption.

Under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FFDCA), any substance found to cause cancer in humans or animals cannot be legally approved as a food additive. As a result, in 1990, the FDA banned Red Dye No. 3 in cosmetics and topical drugs, but it remained approved for use in food and ingested medications.

Consumer advocacy groups, including the Center for Science in the Public Interest (CSPI), have long pushed for a complete ban on the dye, criticizing the inconsistency in safety regulations. After decades of debate, the FDA has now fully revoked its authorization for food and pharmaceutical use, aligning with modern safety standards.

Compliance Standards Moving Forward

With the ban now in effect, manufacturers must take immediate steps to reformulate affected products. The FDA has set the following compliance deadlines:

Food products must remove Red Dye No. 3 by January 15, 2027.
Ingested drugs must be free of Red Dye No. 3 by January 18, 2028.

Companies failing to meet these deadlines will face regulatory action, including product recalls, fines, and potential consumer lawsuits. The ban has created a sense of urgency for manufacturers, requiring them to identify alternative colorants and ensure their ingredient lists reflect the changes.

Scientist holding petri dish with red liquid

Red Dye No. 3 Testing at AccuScience Laboratories

At AccuScience Laboratories, we are committed to helping manufacturers achieve full compliance by offering comprehensive Red Dye No. 3 testing services. Our team of analytical scientists utilizes state-of-the-art technology to detect and quantify Red Dye No. 3 in food, beverages, and pharmaceuticals.

Testing Methods Used

High-Performance Liquid Chromatography (HPLC) – Allows for precise separation and identification of synthetic dyes in complex product formulations.
UV-Vis Spectroscopy – Measures light absorption to determine the concentration of Red Dye No. 3 in various samples.
Thin-Layer Chromatography (TLC) – Provides a visual representation of color additives, helping verify the presence of banned dyes.

Industries We Serve

Food and Beverages – Testing soft drinks, candies, baked goods, and processed foods to ensure compliance.
Pharmaceuticals – Analyzing tablets, capsules, syrups, and other drug formulations to confirm the absence of Red Dye No. 3.
Label Verification – Reviewing product labels to ensure accurate ingredient disclosure and regulatory compliance.

By utilizing our testing services, manufacturers can confidently reformulate their products and avoid potential regulatory penalties.

The AccuCertified Red Dye #3 Free Seal

To help brands demonstrate their commitment to compliance and consumer safety, AccuScience Laboratories offers the “AccuCertified Red Dye #3 Free” seal. This certification verifies that a product has been rigorously tested and confirmed to be free of Red Dye No. 3. By displaying this seal, companies can build consumer trust and differentiate their products in a rapidly evolving regulatory landscape.

Final Thoughts

The FDA’s ban on Red Dye No. 3 marks a major milestone in food safety and consumer protection. With strict compliance deadlines in place, manufacturers must act quickly to reformulate their products and ensure they meet regulatory requirements.

At AccuScience Laboratories, we provide cutting-edge testing services to detect and quantify Red Dye No. 3, ensuring accuracy, compliance, and transparency. With our “AccuCertified Red Dye #3 Free” seal, companies can confidently market their products as safe and compliant.

Need to test your products for Red Dye No. 3? Contact AccuScience Laboratories today!Visit us at: accusciencelabs.com
Email: support@accusciencelabs.com
Call: 352.308.8020