Color Me Natural: Navigating FDA’s planned phase-out of 6 synthetic dyes

On April 22nd the FDA announced a planned phase-out of six petroleum-based synthetic dyes by the end of 2026. While the details and exact timelines of these new regulations are still being finalized, this regulatory change is anticipated to have a considerable impact on the food and beverage industry and major players like PepsiCo are already moving towards natural color alternatives. Our industry contacts also indicate that other large CPG companies are actively allocating resources to address this shift.

At Saphineia, we understand that small and midsize companies may encounter challenges managing during this transition due to limited resources. We’ve outlined a few key considerations to keep in mind as you plan for these changes:

1. Act Now: It’s crucial to begin this work immediately. Don’t assume you have until the end of 2026, as your customers may push for reformulation sooner. Additionally, securing sufficient supplies of certain natural alternatives could become challenging, potentially requiring distributor relationships for smaller order quantities. The process of reformulating products, meeting cost targets, conducting product trials and shelf-life testing, and completing sensory evaluations can be quite demanding within a tight timeframe.
2. Supply Chain and Logistics: Be mindful of the potential complexities in the supply chain and the logistical adjustments needed for natural colors. These often require refrigerated storage to maintain their shelf life before use. Additionally, as natural colors are derived from agricultural sources, their supply can be susceptible to weather and other factors, potentially leading to sourcing difficulties and increased costs due to high market demand.
3. Explore Alternatives and Build Supplier Relationships: It’s important to research the available natural color alternatives and establish relationships with suppliers who can guide you in selecting the right options for your specific formulations. Keep in mind that directly matching FD&C colors (i.e., synthetic colors approved by the FDA for use in food, drugs & cosmetics) with natural alternatives can be challenging and might require using multiple colors to achieve the desired shade. Natural colors also tend to be less stable under heat and more prone to light oxidation, which may necessitate changes in your processing conditions and packaging.
4. Proactively Address Regulatory Requirements: Stay ahead of the evolving regulatory landscape, even if the regulations are not yet fully finalized. You will need to review and set up new raw material specifications in your systems. Each reformulation will require regulatory review and compliant labeling changes. Currently, the FDA is working towards eliminating the following FD&C colors by the end of 2026: Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, and Blue No. 2.
5. Leverage Marketing Advantages: Beyond regulatory compliance, the transition to clean label products presents significant marketing opportunities as consumers increasingly prioritize healthier options. As you make labeling changes, consider the potential impacts of state-specific and international regulations. This shift is likely to drive innovation across the industry, leading to the development of improved natural alternatives and packaging solutions that enhance shelf life.