In a move that has both nutritionists and food scientists raising their kale smoothies in approval, the FDA announced on May 9, 2025, the approval of three new natural food color additives. This decision marks a significant step in the Department of Health and Human Services’ (HHS) initiative to modernize the color additive regulations and phase out synthetic, petroleum-based dyes from the American food supply.
The New Color Additives:
Galdieria Extract Blue: Extracted from Galdieria sulphuraria, a blue color derived from the unicellular red algae Galdieria sulphuraria, this new “natural blue” alternative could help replace synthetic dyes like Blue No. 1.
FDA has approved the color additive for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, and whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).
Butterfly Pea Flower Extract: Previously approved for drinks and juices, this blue color can be used to achieve a range of shades including bright blues, intense purple and natural greens. The color additive, produced through water extractions of the dried flower petals of the butterfly pea plant, is already approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready to drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt.
FDA’s recent color additive petition approval expands the approved use for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), plain corn chips, tortilla chips, and multigrain chips.
Calcium Phosphate: A naturally occurring mineral, this white colorant is now approved for use in ready-to-eat poultry products and various candies.
The Legal Backdrop
This rainbow of reform and regulatory action is part of a broader initiative led by HHS Secretary Robert F. Kennedy Jr. to eliminate synthetic dyes from the food supply. Under this campaign, the FDA aims to phase out eight common petroleum-based artificial dyes, including Red 40, Yellow 5 and Blue 1, targeted for completion by 2027. This move aligns with growing concerns over the potential health risks associated with synthetic dyes, including their alleged links to hyperactivity in children, and their lack of nutritional or functional benefits.
Legal Implications and Considerations for the Food Industry
- Labeling Requirements: Any use of the new color additives must comply with 21 CFR Part 101 (food labeling), including proper declaration under their common or usual names and, where required, specific function (e.g., “for color”).
- Color Certification: While these natural additives do not require batch certification under 21 CFR Part 80 (unlike many synthetic dyes), manufacturers must ensure compliance with identity, purity, and usage specifications.
- Product Reformulation: Food companies using now-targeted synthetic dyes should prepare for reformulation strategies, ensuring that substitutes meet both consumer expectations and regulatory requirements.
- Supply Chain Due Diligence: As demand for natural alternatives grows, sourcing botanical and algal ingredients at scale may raise quality assurance, sustainability, and traceability issues that will require careful contractual and regulatory management.
Navigating the Future of Food Coloring: Compliance, Opportunity, and Strategy
The FDA’s May 9, 2025 approval of these three natural food color additives signals a deliberate shift toward supporting natural, consumer-friendly alternatives in the food industry. It underscores the agency’s intent to modernize outdated color additive regulations and supports the HHS’s initiative to transition the U.S. food system away from petroleum-derived additives.
For companies in the food and beverage industry, these developments offer both opportunity and challenge. Now is the time to reassess product formulations, labeling strategies, and regulatory compliance practices to remain competitive—and compliant—in a rapidly evolving food color landscape.
For guidance on reformulating products, navigating FDA color additive regulations, filing color additive petitions, assessing compliance risks under evolving FDA policy, or for other questions on FDA compliance and enforcement issues, please contact info@garg-law.com.
