Reviewed and Approved by Steven Rogers, Corporate Quality Manager, Certified Group; Lisa El-Shall, Sr. Director of Drug & Device Consulting, EAS Consulting Group; Tim Lombardo, Sr. Director, Food Consulting Services, EAS Consulting Group
On Jan. 15, 2025, the U.S. Food and Drug Administration (FDA) announced a ban on the use of FD&C Red No. 3 (commonly known as Red Dye 3) in food and ingestible drugs. This decision, influenced by studies indicating potential health risks, will significantly affect manufacturers and distributors of food products, over-the-counter (OTC) drugs, and dietary supplements.
To assist in navigating these changes, this FAQ addresses key questions about Red Dye 3, its ban, testing methods, and alternatives. Whether you’re reformulating products or preparing for compliance, this guide offers insights to meet both regulatory requirements and consumer expectations.
1. What is Red 3?
Red Dye 3 is an artificial colorant used to impart a bright, cherry-red hue to various products.
Chemically identified as erythrosine, it has been used in items ranging from candies and baked goods to certain medications for many years. However, concerns about its safety, particularly its carcinogenic potential observed in male rats, have led to scrutiny and recent regulatory action.
2. What is the Official Name of Red 3?
The FDA refers to Red Dye 3 as “FD&C Red No. 3”. This naming convention aligns with the Food, Drug, and Cosmetic (FD&C) Act, which standardizes the designation of color additives approved for use in specific product categories.
Other common identifiers for Red Dye 3 include:
- Erythrosine
- Red Dye #3
- Red No. 3
- Red 3
- E127
- Acid Red 51
- Food Red 14
Understanding these terms is essential for accurate labeling, testing, and compliance efforts.
3. When Does the FDA’s Red 3 Ban in Food and Ingestible Drugs Take Effect?
The FDA’s ban on Red Dye 3 is scheduled to take effect on:
- Jan. 15, 2027, for food products.
- Jan. 15, 2028, for ingestible drugs.
This phased timeline allows manufacturers time to reformulate their products.
Given the growing consumer preference for natural ingredients and potential future regulatory actions on other artificial colors, many companies are proactively exploring natural alternatives to meet market demands and ensure compliance.
4. Is Red Dye 3 Already Banned in Cosmetics?
Yes, the FDA prohibited the use of FD&C Red No. 3 in cosmetics and externally applied drugs in 1990. This action was based on studies demonstrating its association with cancer in laboratory animals, particularly rats.
5. How Do I Test My Raw Materials or Products for Red Dye #3 or Other Artificial Colors?
To ensure compliance with the upcoming ban, it’s crucial to verify that raw materials and finished products are free from Red Dye 3.
Analytical methods such as Thin-Layer Chromatography (TLC) are commonly used for this purpose. TLC allows for the separation and identification of color additives in complex mixtures, making it suitable for testing foods, cosmetics, and ingestible drugs.
Partnering with specialized laboratories for analytical testing, like Certified Laboratories, can provide accurate testing services to detect the presence of FD&C colors and ensure adherence to regulatory standards.
6. What Steps Should Manufacturers Take to Reformulate Their Products Without Red 3 or Other Artificial Colors?
Here are a few steps to take when assessing your products:
- Audit formulations to identify products containing Red Dye 3 or other artificial colors.
- Test your raw materials to ensure they don’t contain undeclared artificial colors.
- During the reformulation process, consider engaging with professionals like EAS Consulting Group, a Certified Group company, for guidance on reformulation and regulatory compliance.
- Test new formulations thoroughly to ensure they meet consumer expectations. This includes conducting stability testing, organoleptic analysis, and chemical analysis, as alternative ingredients can influence shelf life and sensory qualities. Working diligently during this phase will help maintain the quality and appeal of your products.
7. What Artificial Colors Can Certified Laboratories Test For?
Certified Laboratories can test for any FD&C color, but the most common include…
- Blue No. 1
- Blue No. 2
- Green No. 3
- Red No. 3
- Red No. 40
- Yellow No. 5
- Yellow No. 6
8. What are Alternatives to Red 3?
In response to the FDA’s ban and shifting consumer preferences, many manufacturers are considering natural alternatives to Red Dye 3. Some options include…
- Beet juice: Offers a natural red hue suitable for various food applications.
- Anthocyanins: Pigments derived from fruits and vegetables like grapes and berries, providing red to purple shades.
- Carmine: A natural dye obtained from cochineal insects, used in foods and cosmetics.
When evaluating your formulations, consider consulting with food safety and quality experts, such as the team at EAS Consulting Group, a Certified Group company. They can provide recommendations for the best way to proceed to meet both regulatory requirements and consumer expectations.
Where Can I Have My Raw Materials and Products Tested for Artificial Colors?
Contact us today and we’ll be happy to discuss your testing needs for Red 3 and other artificial colors. We offer validated methods for numerous food & beverage, over-the-counter (OTC) drug, cosmetic, and supplement matrices.
For detained shipments into the United States, contact our DWPE sampling and testing team here.