United States (US) FDA Color Additive Regulatory Changes and Key Compliance Measures for Enterprises

Over the past year, the FDA has re-evaluated the safety of petroleum-based synthetic color additives (i.e., certified color additives) and initiated a phase-out process.

Ban on Erythrosine (FD&C Red No. 3): In January 2025, the FDA formally revoked authorization for the use of Red No. 3 in food and oral medications. Although studies indicate that the mechanism by which this colorant causes cancer in rats does not apply to humans, the law strictly prohibits the use of any carcinogenic substance as a color additive. The FDA requires food manufacturers to complete reformulation by January 15, 2027.

Orange B: In September 2025, since the industry has largely abandoned the use of the petroleum-based pigment Orange B, the FDA proposed revoking its authorization to clear out outdated regulations.

Six core colorants included in review: The FDA has placed the six remaining petroleum-based colorants commonly used in foods—such as Allura Red (FD&C Red No. 40), Tartrazine (FD&C Yellow No. 5), and Brilliant Blue (FD&C Blue No. 1)—on its priority review list, and has established an “Industry Commitment Tracker for Phasing Out Petroleum-Based Colorants” to publicly monitor companies’ phase-out progress.

Approval of natural color additives: To fill the supply gap left as synthetic color additives are gradually phased out of the market, the U.S. FDA is accelerating the approval and authorization process for natural alternative color additives to help food companies smoothly transition their formulations. At present, the FDA is both expediting the market entry approval of new natural color additives and expanding the permitted uses of existing compliant natural color additives. Recently, the FDA approved beetroot red as a new color additive (with the effective date delayed) and further broadened the permitted use scope of spirulina extract. To date, the number of natural color additives that have received new approvals or expanded use authorizations has reached six.

Corporate Suggestions

(1) Review the use of erythrosine (FD&C Red No. 3) in food products, and ensure that all formula changes and inventory depletion are completed before January 15, 2027.

(2) For the six synthetic color additives already included on the review list—Allura Red (FD&C Red No. 40), Tartrazine (FD&C Yellow No. 5), Sunset Yellow FCF (FD&C Yellow No. 6), Brilliant Blue FCF (FD&C Blue No. 1), Indigotine (FD&C Blue No. 2), and Fast Green FCF (FD&C Green No. 3)—companies are advised to establish internal early-warning plans. Although they are not currently banned, as the “MAHA” initiative advances, the likelihood of tighter regulation in the future is extremely high.

(3) Natural colorants differ from synthetic colorants in terms of stability (light and heat stability) and color gamut richness, so the R&D department needs to plan ahead. Closely monitor regulatory developments regarding the approval of natural colorants and conduct color-matching experiments using the latest approved colorants.

While encouraging the transition, the FDA has not relaxed its safety standards. Because natural colorants are significantly affected by plant varieties, environmental conditions, and production methods, the risk of heavy metal contamination cannot be overlooked.

The FDA reminds manufacturers that all exempt certified color additives (natural color additives) must meet strict specification requirements. The FDA recommends that companies refer to the new standards in the "Food Chemicals Codex" (FCC) regarding "Guidelines for Contaminant Control for Natural Source Food Color Additives," particularly in controlling heavy metals (such as lead and mercury), solvent residues, and microorganisms, and that the strictest control measures should be taken.

Enterprise Recommendations

The FDA has made it clear that it will strengthen regulation of the purity of natural color additives. Companies should enhance quality control over raw materials for natural colorants. For color additives for which no quality specifications are provided in 21 CFR Part 73, suppliers may be required to provide test reports that comply with the requirements of Appendix XXI of the Food Chemicals Codex (FCC).

This is the most groundbreaking policy adjustment in recent times. For a long time, the FDA did not distinguish the source of "artificial color additives"; any color added, even if extracted from plants, was considered "artificial." On February 5, 2026, the FDA issued a notice allowing products that do not contain petroleum-based synthetic colors to claim "no artificial color additives."

That is, as long as the product does not contain any synthetic certified color additives listed in 21 CFR Part 74, claims such as “Made without artificial food colors/colorings,” “No artificial color/colors/coloring,” and “No added artificial color/colors/coloring” may be used.

Enterprise Recommendations

If your product has achieved de-petroleumization, you should immediately label "No Artificial Colors" or "Made without artificial food colors" prominently on the packaging in accordance with the FDA's enforcement discretion guidelines. Be sure to confirm that the product does not contain any certified color additives listed in 21 CFR part 74 (even as a trace ingredient). Once found to contain trace amounts of synthetic color additives while being labeled "no artificial colors," you will face FDA penalties for fraudulent labeling.

The FDA’s coordinated regulatory approach to color additives—marked by stricter bans, faster approvals, looser labeling requirements, and more refined oversight—reflects a clear regulatory logic: using regulatory pressure to drive petroleum-based color additives off the stage of history, while leveraging flexible labeling policies and technical guidance to steer the food industry toward a healthier, more natural “real food” model. This represents not only an iterative update of food technology regulation, but also the practical implementation in the food safety arena of the national strategy to “Make America Healthy Again” (MAHA). In the face of this systemic regulatory shift, relevant companies should continue to closely monitor the latest developments in U.S. regulations, plan ahead, and respond proactively to the implementation of petroleum-based color additive bans by accelerating the development and commercialization of compliant natural color alternatives. At the same time, they should exercise strict control over the quality of natural color additives to reduce the risk of excessive contaminant levels in their products.