The FDA has already banned Red No. 3 and announced a regulatory roadmap to eliminate other synthetic dyes from the U.S. food supply. This includes revoking authorization for Citrus Red No. 2 and Orange B, and working with industry to phase out FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3 by the end of next year.
While targeted at food products, this regulatory pressure has direct implications for supplement brands, especially those using synthetic dyed capsules as part of their delivery systems. Reformulating with natural alternatives is becoming more common and those who act now will have a clear operational advantage.
Changing Capsule Colors in a Shifting Regulatory Landscape
Reformulating existing products while maintaining capsule integrity demands precise control over color stability, shell performance, and fill compatibility.
As global standards become more stringent and clean label expectations rise, brands must:
- Adapt formulations without compromising capsule disintegration, machinability, or stability
- Replace synthetic-based dyes with natural alternatives that perform reliably under production conditions
- Ensure compliance with international regulations, such as the EU ban on TiO₂ and anticipated FDA color or ingredient restrictions
- Secure a dependable supply chain for high-quality, plant-based pigments at commercial scale
At CapsCanada, we offer capsule solutions tailored to meet these demands.
Formulate Without Synthetic Dyes: K-CAPS® Natural Colorants in Capsules
CapsCanada’s K-CAPS® HPMC capsules are plant-based and manufactured for maximum formulation flexibility and regulatory compliance.
Key advantages include:
- Colorants of Natural Origin: sourced from botanical ingredients such as annatto, safflower, spirulina, caramel, vegetable carbon, red radish, and more.
- Naturally TiO₂-free: Because K-CAPS® are plant-based and colored exclusively with natural pigments, they are inherently free of titanium dioxide, ensuring full alignment with clean-label expectations and current EU regulatory bans.
- Excellent machinability and performance in high-speed filling machines.
- Certified Kosher, Halal,Non-GMO, registered by the Vegan Society and allergen-free
We offer the widest selection of natural colorant capsules available on the global market - a key differentiator for brands seeking visual customization without synthetic dyes.
Clean-Label Capsules: Supporting Compliance and Brand Trust
Transitioning to naturally colored K-CAPS® supports operational agility, regulatory readiness, and brand differentiation in an increasingly restrictive landscape:
- Supports compliance with FDA’s upcoming dye restrictions and EU's existing TiO₂ ban
- Reduces regulatory friction during formulation updates and new product submissions
- Aligns with consumer demand for transparency, safety, and plant-derived ingredients
- Improves brand positioning through traceability, clean labeling, and technical excellence
The Future of Capsules Is Going Natural: Reformulating Without Synthetic Dyes
As regulators dismantle synthetic additive policies, manufacturers are being asked to lead in this transition, not just comply. Clean label requirements are no longer a niche or a trend, but a necessity based in growing demand. .
We are at the forefront of this transition. With unrivaled capabilities in manufacturing capsules with colorants of natural origin we help pharmaceutical and supplement brands safeguard their formulations, brand reputation, and future growth.
Partner with CapsCanada, contact us to get a sample of our new natural colorant options.
