Goodbye to synthetic colors: how to navigate new FDA rules
2025 has been a year of major changes in the U.S. food industry. If your products contain artificial colorants, this guide is essential for you.
New FDA regulations: phasing out petroleum-based colorants
On April 22, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS), announced a plan to gradually eliminate petroleum-derived synthetic colorants in food products. This follows the recent ban on Red No. 3 earlier this year.
The transition will be gradual, implemented through national standards and a mandatory timeline for manufacturers. The estimated compliance date is late 2026, although an official date has not yet been released.
Which colorants will be affected?
The new regulation will impact the following synthetic colorants:
- Citrus Red No. 2
- Orange B
- FD&C Green No. 3
- FD&C Red No. 40
- FD&C Yellow No. 5
- FD&C Yellow No. 6
- FD&C Blue No. 1
- FD&C Blue No. 2
If your product contains any of these, it’s time to consider alternatives.
Approved alternatives
The FDA is currently evaluating natural colorants as replacements. New approvals are expected in the coming weeks, and the review process is expected to accelerate to support manufacturers transitioning to healthier and safer ingredients.
Why now?
This initiative is part of “Make America Healthy Again”, aimed at curbing the growing epidemic of chronic diseases in the U.S. Recent studies have linked certain synthetic colorants to potential health risks, particularly in children.
The U.S. is aligning its standards with Europe and Canada, where natural colorants are already the norm.
What this means for manufacturers
Although the transition will be gradual, the recommendation is not to wait. If you are entering the U.S. market or already selling products with synthetic colorants, start planning your reformulation now.
How CORE can help
At CORE, we help you adapt your products to new FDA requirements. We provide step-by-step support to ensure your products remain compliant and competitive in the market.
Contact us today to begin your transition to natural colorants and stay ahead of regulatory changes.
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2025 has been a year of major changes in the U.S. food industry. If your products contain artificial colorants, this guide is essential for you.
New FDA regulations: phasing out petroleum-based colorants
On April 22, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS), announced a plan to gradually eliminate petroleum-derived synthetic colorants in food products. This follows the recent ban on Red No. 3 earlier this year.
The transition will be gradual, implemented through national standards and a mandatory timeline for manufacturers. The estimated compliance date is late 2026, although an official date has not yet been released.
Which colorants will be affected?
The new regulation will impact the following synthetic colorants:
- Citrus Red No. 2
- Orange B
- FD&C Green No. 3
- FD&C Red No. 40
- FD&C Yellow No. 5
- FD&C Yellow No. 6
- FD&C Blue No. 1
- FD&C Blue No. 2
If your product contains any of these, it’s time to consider alternatives.
Approved alternatives
The FDA is currently evaluating natural colorants as replacements. New approvals are expected in the coming weeks, and the review process is expected to accelerate to support manufacturers transitioning to healthier and safer ingredients.
Why now?
This initiative is part of “Make America Healthy Again”, aimed at curbing the growing epidemic of chronic diseases in the U.S. Recent studies have linked certain synthetic colorants to potential health risks, particularly in children.
The U.S. is aligning its standards with Europe and Canada, where natural colorants are already the norm.
What this means for manufacturers
Although the transition will be gradual, the recommendation is not to wait. If you are entering the U.S. market or already selling products with synthetic colorants, start planning your reformulation now.
How CORE can help
At CORE, we help you adapt your products to new FDA requirements. We provide step-by-step support to ensure your products remain compliant and competitive in the market.
Contact us today to begin your transition to natural colorants and stay ahead of regulatory changes.
2025 has been a year of major changes in the U.S. food industry. If your products contain artificial colorants, this guide is essential for you.
New FDA regulations: phasing out petroleum-based colorants
On April 22, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS), announced a plan to gradually eliminate petroleum-derived synthetic colorants in food products. This follows the recent ban on Red No. 3 earlier this year.
The transition will be gradual, implemented through national standards and a mandatory timeline for manufacturers. The estimated compliance date is late 2026, although an official date has not yet been released.
Which colorants will be affected?
The new regulation will impact the following synthetic colorants:
- Citrus Red No. 2
- Orange B
- FD&C Green No. 3
- FD&C Red No. 40
- FD&C Yellow No. 5
- FD&C Yellow No. 6
- FD&C Blue No. 1
- FD&C Blue No. 2
If your product contains any of these, it’s time to consider alternatives.
Approved alternatives
The FDA is currently evaluating natural colorants as replacements. New approvals are expected in the coming weeks, and the review process is expected to accelerate to support manufacturers transitioning to healthier and safer ingredients.
Why now?
This initiative is part of “Make America Healthy Again”, aimed at curbing the growing epidemic of chronic diseases in the U.S. Recent studies have linked certain synthetic colorants to potential health risks, particularly in children.
The U.S. is aligning its standards with Europe and Canada, where natural colorants are already the norm.
What this means for manufacturers
Although the transition will be gradual, the recommendation is not to wait. If you are entering the U.S. market or already selling products with synthetic colorants, start planning your reformulation now.
How CORE can help
At CORE, we help you adapt your products to new FDA requirements. We provide step-by-step support to ensure your products remain compliant and competitive in the market.
Contact us today to begin your transition to natural colorants and stay ahead of regulatory changes.
