Key update: In 2025, the U.S. Food and Drug Administration (FDA) approved three food color additive petitions involving Galdieria extract blue, butterfly pea flower extract, and calcium phosphate. The approvals form part of a broader U.S. policy direction to support alternatives to petroleum-based synthetic dyes in food.
On May 9, 2025, the U.S. Food and Drug Administration (FDA) announced that it had approved three food color additive petitions, covering:
Galdieria extract blue;
Butterfly pea flower extract;
Calcium phosphate.
These three color additive approvals expand the palette of food colors available from natural or alternative sources for food manufacturers. They also reflect the FDA’s stated direction to support the food industry’s transition away from certain petroleum-based synthetic dyes.
Accelerated Approval of Food Color Alternatives Following the HHS-FDA Joint Statement
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the FDA jointly announced a series of measures to phase out petroleum-based synthetic dyes from the U.S. food supply. According to the HHS-FDA announcement, the measures include establishing a national transition timeline, initiating the revocation process for certain synthetic food colorings, working with industry to eliminate several remaining FD&C dyes, accelerating approval of alternative color additives, and supporting further research.
At the time, the FDA stated that it was fast-tracking the review of color alternatives such as calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract, and other alternatives to synthetic food dyes. The May 2025 approval announcement came shortly after that joint statement.
U.S. Plan to Phase Out Petroleum-Based Synthetic Dyes
In public remarks, HHS and FDA officials emphasized that the U.S. food industry should transition away from petroleum-based synthetic dyes and toward alternative color sources. The policy direction reflects growing regulatory and public attention to the use of certified synthetic colors in foods, especially products consumed by children.
The FDA’s announced roadmap included the following actions:
Initiating the process to revoke authorizations for Citrus Red No. 2 and Orange B;
Working with industry to eliminate six remaining synthetic dyes, namely 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, and FD&C Blue No. 2;
Requesting food companies to remove FD&C Red No. 3 sooner than the previously required 2027-2028 deadline;
Accelerating the authorization of additional food colors from natural or alternative sources.
As of June 2026, the transition remains active. The FDA continues to maintain an industry pledge tracker for companies and associations that have announced commitments to remove certified color additives or petroleum-based food dyes from certain product portfolios.
Important Notice for Food Exporters to the U.S.
This reform in food color regulation represents an important turning point in U.S. food safety oversight. For food manufacturers, ingredient suppliers, and exporters to the U.S. market, the policy direction may increase the need to review product formulations, label declarations, approved color additive uses, and supply chain readiness. Companies exporting food products to the U.S. may also need to reassess their broader U.S. food regulatory compliance obligations.
The policy shift is expected to affect a wide range of food categories, including confectionery, beverages, snacks, cereals, dairy-based products, and other processed foods that use certified synthetic colors. Food companies exporting to the U.S. should closely monitor FDA updates and assess whether existing formulations rely on color additives that may be affected by the transition.
For companies using food ingredients, additives, colorants, botanical extracts, fermentation-derived ingredients, or other functional components in the U.S. conventional food market, it is also important to review whether the ingredient has a suitable regulatory basis, such as an approved food additive regulation, a color additive regulation, or a GRAS conclusion where applicable. For broader ingredient pathway assessment, companies may refer to U.S. FDA GRAS for Food Ingredients.
Set forth below are the FDA-authorized food uses and regulatory status of the three color additives covered by the May 2025 approval announcement. The relevant Federal Register orders were published in May 2025 and became effective on June 26, 2025.
Galdieria Extract Blue
Galdieria extract blue is a blue color additive derived from the unicellular red alga Galdieria sulphuraria.
The FDA has authorized the use of this color additive in non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milkshakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candies, soft candies, chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices, popsicles, gelatin desserts, puddings, custards, whipped cream, yogurt, frozen or liquid creamers, and whipped toppings, subject to the applicable regulatory restrictions and good manufacturing practice.
Butterfly Pea Flower Extract
Butterfly pea flower extract is produced through aqueous extraction of dried petals of the butterfly pea plant, Clitoria ternatea. The color additive can be used to achieve bright blue, intense purple, and natural green hues.
The FDA had previously authorized butterfly pea flower extract for use in categories including sports drinks, juice drinks, fruit and vegetable juices, alcoholic beverages, dairy-based beverages, ready-to-drink teas, nutritional beverages, chewing gum, confectionery, coated nuts, ice cream, and yogurt.
Under the 2025 approval, the authorized uses were expanded to include ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips, and multigrain chips, subject to the applicable restrictions and good manufacturing practice.
Calcium Phosphate
Calcium phosphate has been added to the list of color additives exempt from certification. The FDA authorized its use as a white color additive in specified food applications.
The authorized uses include ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies, subject to use-level restrictions specified in the applicable regulation.
How REACH24H Can Help
REACH24H supports food manufacturers, ingredient suppliers, and exporters in assessing U.S. food ingredient and additive compliance requirements, including color additive regulatory status, permitted use categories, formulation review, labeling considerations, and market access strategy. Our food regulatory team also provides support for U.S. Food Regulatory Compliance, U.S. FDA GRAS for Food Ingredients, and Global Food Compliance Service.
Assessment of whether a color additive is permitted for the intended food category in the U.S.;
Review of formulation and labeling risks related to synthetic dyes and alternative color sources;
Regulatory pathway analysis for food ingredients, additives, and color additives;
Support for dossier strategy, data gap analysis, and communication with relevant stakeholders.
