FDA Accelerates Shift Toward Natural Food Colors

Industry Insights by Next Move Strategy Consulting

The U.S. Food and Drug Administration has approved the color additive petition submitted by the Gardenia Blue Interest Group (GBIG), allowing the use of gardenia (genipin) blue in a range of food products, provided it adheres to good manufacturing practices. 
This marks the fourth natural-source food color additive the FDA has approved in the past two months.

FDA Decision Supports National Push to Eliminate Synthetic Dyes

The FDA’s recent approval aligns with U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s initiative to collaborate with industry leaders in phasing out all synthetic, petroleum-based dyes from the U.S. food supply. This move is part of the administration’s broader “Make America Healthy Again” campaign.

Since Secretary Kennedy introduced a series of initiatives in April aimed at phasing out petroleum-based synthetic dyes in food, approximately 40% of the food industry has voluntarily pledged to eliminate these additives from their products.

FDA Approves Gardenia Blue for Use in Beverages and Confectionery Products

Gardenia (genipin) blue, sourced from the fruit of the gardenia—a flowering evergreen plant—has been approved by the FDA as a color additive for use in a variety of products, including sports drinks, flavored or enhanced non-carbonated waters, fruit beverages and ades, ready-to-drink teas, as well as hard and soft candies.

Recently Approved Natural Color Additives and FDA Regulatory Framework

• Natural Color Additives Approved in May 2025:

  • Galdieria Extract Blue: A blue colorant derived from the unicellular red algae Galdieria sulphuraria.

  • Calcium Phosphate: A white powder used for color in various food applications.

  • Butterfly Pea Flower Extract: A plant-based blue dye capable of producing a spectrum of colors including vibrant blue, deep purple, and natural green shades.

• FDA Regulatory Process for Color Additives (per Section 721 of the FD&C Act):

  • All color additives must be approved by the FDA before they can be used in foods.

  • The FDA evaluates:

    • Projected dietary exposure to the color additive.

    • Toxicological data to assess potential health risks.

    • Relevant scientific information, including peer-reviewed literature.

  • Once approved, color additives can be used by any manufacturer, provided they comply with the specified conditions of use.

FDA Urges Early Phase-Out of Red No. 3

Alongside the approval of a new color additive, the FDA announced it has issued a letter to manufacturers encouraging them to phase out the use of FD&C Red No. 3 in food products and dietary supplements ahead of the January 15, 2027, deadline. This recommendation supports a broader series of initiatives introduced by Secretary Kennedy in April. In the letter, the FDA stated that accelerating the removal of Red No. 3 aligns with the goal of “Making America Healthy Again.”

Source: https://www.fda.gov/

Prepared by: Next Move Strategy Consulting