Reformulating Without Artificial Dyes: Why Stability Studies Are Critical
As consumer demand for cleaner labels and naturally derived ingredients continues to rise, many manufacturers of OTC and dietary supplement products are reformulating to remove artificial colors and dyes. While this shift aligns with market trends, it introduces significant challenges—especially when it comes to product stability.
This is where stability testing becomes essential. Reformulating without dyes may not be a minor change in the eyes of regulators. For both monograph and NDA/ANDA products, FDA guidance expects manufacturers to demonstrate that any reformulation maintains product identity, strength, quality, and purity throughout its shelf life.
Why Stability Testing Matters in Dye-Free Reformulations
Removing synthetic colorants may affect more than just appearance. These ingredients often play a functional role in protecting products from environmental stressors like light and heat. Without them, manufacturers must reassess how their products hold up over time.
Key considerations include:
- Real-time and accelerated stability studies to simulate shelf-life conditions
- Photostability testing, especially when removing dyes that previously helped mitigate light exposure
- Monitoring of natural colorants, which may degrade faster or shift in hue due to environmental factors
Natural alternatives—such as plant-based pigments—can be far more sensitive to oxidation, pH changes, and UV exposure. Without robust stability data, these reformulations risk failing to meet regulatory expectations or consumer standards.
Appearance Matters—Especially for Pediatric Products
For products that rely on color as part of their identification, such as pediatric syrups, gummies, or chewable tablets, removing a visual marker can impact a consumer’s confidence in the product. A change in appearance may lead to confusion, reduced compliance, or diminished trust in the product.
That’s why appearance tracking is key to any stability protocol. This includes:
- Documenting color changes over time
- Assessing packaging’s ability to protect against light
- Evaluating consumer perception through sensory studies, if applicable
Navigating Regulatory Expectations
The FDA expects manufacturers to treat dye removal as a formulation change, that may require updated stability data to support continued product approval. Whether you're working with a monograph OTC or a regulated NDA/ANDA product, stability studies are your proof of consistency and control.
Partnering for Success
At Eurofins Supplement & OTC Testing in Madison, WI, we support manufacturers through every stage of reformulation. Our stability testing programs are designed to meet regulatory standards while helping you maintain product integrity, appearance, and consumer trust.
Ready to reformulate with confidence? Let’s talk about how our stability expertise can support your clean-label goals.
