NEWS & BLOGS

Beyond the Allure of Color: Navigating FDA Food Dye Regulations and the Clean Label Trend

Provision Consulting Group
Sep 22
3 min read

Updated: Sep 24

Decades-long controversies over synthetic food dyes have finally led to a formal phase-out process in the U.S. The FDA is actively strengthening its regulations on artificial food colors, beginning with the long-debated Red No. 3. The agency announced a plan for a phased withdrawal of synthetic dyes, and more recently, it has initiated the process to revoke the authorization of specific colors, including Citrus Red No. 2 and Orange B. This demonstrates the FDA's readiness to make bold decisions on ingredients with potential risks.

This isn't just about a single dye. It’s a response to growing social concerns linked to children's health issues, such as ADHD, obesity, and depression. As the FDA Commissioner emphasized, the best course of action is to "remove potential risk factors."

Which Products Are Affected?

A wide range of everyday products are impacted, including popular candies, cereals, beverages, frozen foods, and baked goods—essentially, most of the "colorful" products you see in grocery stores. The regulation also extends to some children's medications, requiring a comprehensive transition across the industry.

The Shift to Natural Alternatives

The FDA is collaborating with the industry to encourage the use of natural, plant-based colors. To provide safe alternatives, the agency is accelerating the review and approval of several natural color additives, such as Galdieria Extract Blue. This promises a future where products are not only visually appealing but also safer for consumers, offering companies a chance to implement a "clean label" strategy.

Navigating Dual Federal and State Regulations of food dyes

The U.S. market's complexity is defined by the independent laws of each state alongside federal FDA regulations. While the FDA's phase-out relies on a largely voluntary approach, some states have already enacted mandatory, legally binding regulations. For example, California and West Virginia have passed laws that ban certain harmful additives from school food, moving ahead of federal action. This means companies must prepare for regional regulatory differences and tailor their strategies accordingly.

FDA Guidelines and Regulatory Direction

Food Color Regulations: The FDA aims to phase out petroleum-based synthetic dyes, including Red No. 3, by 2027 and is fast-tracking the approval of natural alternatives.
Labeling Guidelines: Manufacturers are now required to list the exact name of each color on ingredient labels. In addition, some states (like Texas and Louisiana) have passed laws mandating warning labels or QR code notices for products containing specific additives.
FSMA and Post-Market Review: The FDA continues to re-evaluate previously approved additives based on the latest scientific evidence. It is also strengthening its system for identifying and blocking potentially harmful ingredients early through new risk-assessment tools.
Review of Ultra-Processed Foods: The FDA and USDA are working to establish a definition for ultra-processed foods, which could lead to expanded regulations on overall processing levels and additives.

The FDA's recent actions are part of a broader movement focused on food safety, consumer trust, and global competitiveness. For companies, complying with these new regulations is not just a legal requirement but a way to embrace the "new standard" of the U.S. market. A comprehensive and proactive regulatory strategy that encompasses both federal and state laws is now essential for success.