Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out

On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. 3 in food prior to the previously announced 2027 deadline.

This dual action underscores FDA’s continued alignment with and focus on the Make America Healthy Again (MAHA) initiative, which focuses on, among other things, the removal of petroleum-based synthetic dyes from foods.

“Natural Colors” In, Artificial Dyes Out

FDA has long claimed that there is no such thing as a natural color, as any color additive is artificial.  Any color substance, no matter if it is nature-derived or petroleum-based, must be approved by FDA via a color additive petition (CAP).  As we reported previously, the Department of Health and Human Services Secretary, Robert F. Kennedy, Jr., has highlighted the removal of petroleum-based synthetic dyes as a focus of the MAHA campaign.  See also link.  FDA has withdrawn the approval of Red No. 3 based on evidence that it causes cancer in animals, but even though there is no evidence that they are unsafe, Secretary Kennedy has encouraged industry to also (voluntarily) remove any and all petroleum-derived dyes from foods.  To aid the industry in this effort, FDA appears to have accelerated approval of nature-derived color additives, often referred to as “natural colors.”

Gardenia Blue, derived from the fruit of the Gardenia jasminoides plant using genipin, is the latest in a string of plant-based color additives to receive FDA approval.  It joins three others, which FDA authorized in May, two plant-based colors and one mineral-based color, reflecting a clear regulatory trend toward food colors derived from nature.  FDA determined that Gardenia Blue, meeting certain specifications, is safe for use in a variety of foods, such as sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, and hard and soft candy.

Although color additive approvals result from CAPs and the relevant petitions have been in the pipeline for several years, the four approvals so far under this administration appear to mark a sharp uptick from years prior.  In 2025, before President Trump took office, there was one approval for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.  In 2024, there were zero approvals.  In 2023, there was one approval for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories, and, in 2022, there were three approvals for the safe use of spirulina (Arthrospira platensis), calcium carbonate, and Antarctic krill meal in various food products (link, link, link).  As of this writing, there are an additional four CAPs pending review.

These approvals align with MAHA’s broader strategy to replace petroleum-based synthetic color additives with consumer-preferred alternatives—a move that also responds to public pressure.

Red No. 3 Gets a Firm Deadline

For decades, Red No. 3 has faced criticism due to research linking it to cancer in lab animals (see, e.g., link).  Although it was banned in cosmetics in 1990, it remained legal for use in foods—until recently.  In response to a petition from 2022, FDA revoked Red No. 3’s authorization and repealed the relevant regulation.

FDA has set a firm deadline of January 15, 2027 for manufacturers to phase out the use of Red No. 3 in food products.  However, FDA encourages the industry to remove the color additive as soon as possible.  According to the Agency’s official announcement, this phase-out aims to “further the goal of Making America Healthy Again” and reduce health risks associated with synthetic dyes.

FDA has pledged to offer guidance and technical support to the industry throughout the transition.  Prompt approval of alternatives to Red No. 3 and other certified colors would certainly help accelerate the phase out.  That said, every new color comes with its own challenges, and the industry will need time to adjust processing and formulation to produce the right color using a color additive.

MAHA Agenda Continues to Gain Momentum

This regulatory momentum is part of a wider effort spearheaded by Secretary Kennedy, who has made food reform a central pillar of the MAHA agenda.  Among other things, the initiative aims to eliminate “unsafe additives.”

FDA’s FY 2026 budget request includes $49 million to support food chemical evaluations, safety reviews of high-risk additives like phthalates and synthetic dyes, and the development of a post-market surveillance system for food additives.

Industry Impact and Takeaways

As we have cautioned and discussed before (here, here), food and beverage companies should take careful note of these developments and related state-level initiatives.  With FDA setting clear deadlines and increasingly favoring plant-based alternatives, proactive adaptation will be critical.  Companies that invest in reformulation and label transparency will be better positioned to meet regulatory requirements and consumer expectations.