The U.S. Food and Drug Administration (FDA) has approved gardenia blue, a plant-derived color additive, for limited use in certain foods. At the same time, the agency is encouraging a faster transition away from synthetic FD&C Red No. 3 due to growing safety concerns.
These developments reflect the FDA’s evolving approach to color additive safety and may affect ingredient choices and labelling practices across the food, dietary supplement, and confectionery industries.
If your products use synthetic dyes or color additives, this shift could impact your sourcing, formulation, and compliance strategies. Keep reading to learn what’s changing, and how your business can stay ahead.
What did the FDA approve and why does it matter?
The FDA recently approved gardenia blue, derived from genipin extracted from Gardenia jasminoides, for use as a color additive in certain foods. The approval comes after a color additive petition submitted by a global ingredient manufacturer, which included safety data, identity specifications, and manufacturing information.
The green light for gardenia blue provides manufacturers with a new plant-based alternative at a time when public concern over synthetic dyes continues to grow. Furthermore, the FDA has also reiterated its intention to accelerate the phase-out of FD&C Red No. 3 due to potential health concerns.
Here’s how gardenia blue and FD&C Red No. 3 compare:
Attribute | Gardenia Blue | FD&C Red No. 3 |
Source | Plant-derived (genipin from Gardenia jasminoides) | Synthetic (erythrosine) |
Approved uses | Candies, bakery coatings, frozen desserts | Foods, beverages, supplements, medications |
Key concerns | Limited use approval; identity and purity required | Linked to thyroid tumors in animal studies |
Regulatory status | Recently approved for limited food use | Still approved but under pressure to phase out |
Consumer perception | Favored for clean-label formulations | Increasing concern over synthetic dyes |
What is gardenia blue (genipin) and how is it used?
Gardenia blue is produced through the reaction of genipin, a naturally occurring compound found in gardenia fruit, with amino acids. It results in a blue pigment that is stable under heat and light, making it suitable for various applications such as:
- Candies and chewing gum
- Bakery decorations and coatings
- Ice cream and frozen desserts
Therefore, manufacturers must ensure that gardenia blue meets all identity and purity specifications as outlined by the FDA before using it in food products.
Why is FD&C Red No. 3 being phased out?
FD&C Red No. 3, also known as erythrosine, has long been a subject of safety reviews. In 1990, the FDA banned its use in cosmetics and externally applied drugs, citing evidence of thyroid tumors in animal studies. However, it remained approved for use in foods and oral medications.
Now, with mounting pressure from advocacy groups and evolving consumer preferences for natural ingredients, the FDA is encouraging manufacturers to move away from Red No. 3 in food and supplement products. While the agency has not yet banned it outright, the signal is clear: its use will likely become more limited in the near future.
How does this impact food and supplement companies?
This dual announcement by the FDA represents both a challenge and an opportunity:
- Ingredient reformulation: If your product currently includes Red No. 3, you may need to begin sourcing and testing alternative colorants such as gardenia blue or other FDA-approved natural options.
- Labelling updates: Switching to new color additives may require updates to ingredient labels, technical documentation, and marketing materials.
- Regulatory documentation: You’ll need to ensure your formulations and labels remain compliant with current FDA regulations.
Companies in the natural health product space should also review any dietary supplements that use synthetic dyes. The demand for clean-label alternatives continues to rise, and staying ahead of these changes can give your brand a competitive edge.
What should you do now?
To stay compliant and minimize disruption, we recommend that you:
- Audit your product formulations for the presence of Red No. 3.
- Evaluate alternative ingredients, such as gardenia blue, and assess compatibility with your product matrices.
- Update your regulatory documentation and labelling in line with new FDA approvals.
You can read the full FDA announcement here.
FAQs About Gardenia Blue and Red No. 3 Compliance
Is FD&C Red No. 3 now banned in foods
No. While the FDA encourages a faster phase-out, it has not officially banned Red No. 3 in food products at this time.
Can gardenia blue be used in all food products?
Not yet. Gardenia blue is currently approved for use in specific food categories, such as candy and baked coatings. Be sure to follow FDA guidelines for permitted uses.
The good news is that transparent, proactive responses with expert guidance can improve your chances of a successful renewal.
Is gardenia blue considered a “natural color”?
Yes. Gardenia blue derives from a plant and it’s considered a naturally sourced color additive, which aligns with clean-label trends.
How do I update my formulas or documentation?
You can start by auditing your current formulas. Our regulatory experts at Quality Smart Solutions can guide you through ingredient changes and ensure your compliance documentation stays up to date.
Stay compliant with FDA color additive regulations
As FDA regulations evolve, having a proactive strategy is essential. Whether you’re reformulating due to Red No. 3 or exploring gardenia blue, our team can support your compliance, documentation, and labelling needs.
Contact us today or explore our food compliance solutions and ingredient compliance services to get tailored support for your product portfolio.
