Bye, bye, carcinogenic dyes? These 3 supplements just got FDA approval as food dyes

In April 2025, the FDA, under HHS leadership, announced the phase‑out of eight petroleum‑based synthetic dyes (including Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, Green No. 3, Citrus Red No. 2, and Orange B), citing mounting evidence from animal studies linking them to cancer and neurobehavioral effects in children.^[]

According to board-certified physician Alok Mohta, MD, MBBS, “Many of the petroleum-based dyes, like Red No. 3, for example, are now classified as ‘reasonably anticipated to be a human carcinogen’ by the National Toxicology Program.”

Most major ice cream and frozen dessert companies have pledged to phase out seven synthetic dyes by 2028^[]—a regulatory push that will expand commercial use of gardenia blue and existing approved colorants.

These measures are part of FDA and HHS efforts to phase out synthetic petroleum‑based dyes from the greater US food supply by 2027.^[] The shift marks a turning point in the FDA’s approach to food coloring—favoring plant- and mineral-based alternatives over synthetic dyes with known risks. With the spotlight now on safer substitutes, these three newly approved natural colorants are poised to play a major role in the transition. Here’s what else physicians should know about them.

Gardenia (genipin) blue

Gardenia blue is synthesized when genipin, a naturally occurring iridoid from Gardenia jasminoides fruit, reacts with amino acids (glycine, phenylalanine, or lysine), resulting in a blue pigment resistant to heat, light, and pH.^[] This resistant profile makes genipin blue useful for food processing and storage.

Toxicological assessments, including joint FAO/WHO review, determined that impurity levels are safe at expected dietary intakes.^[]

As for allergenicity, gardenia blue production involves soy protein hydrolysate.^[] While the final product lacks detectable soy residues, soy allergy implications remain under FDA review.

“No published case reports link gardenia blue to hypersensitivity. However, vigilance is warranted in soy-allergic patients until further provenance validation is available,” Dr. Mohta says.

Butterfly pea flower extract

Extracted via aqueous processing of Clitoria ternatea petals, butterfly pea flower extract contains anthocyanins and flavonols (quercetin and kaempferol).^[]

Until now, butterfly pea flower extract was already approved for use in sport drinks, fruit juices, dairy drinks, ice cream, yogurt, and even alcoholic beverages.^[] In May 2025, the FDA approved the use of this in cereals, snack mixes, crackers, hard pretzels, and several types of chips. This approval was pushed by a petition from the St. Louis-based Sensient Colors LLC.

A 90-day study established no observed adverse effect level (NOAEL) of 3,500 mg/kg/day of butterfly pea flower, a nearly 500-fold margin of exposure compared to anticipated human intake of 9.3 mg/day at the 90th percentile for people in the US aged 2 years and older.^[] This makes the pea extract extremely unlikely to cause harm, even with high daily intake.

Calcium phosphate

A synthetically prepared white pigment already designated as generally recognized as safe (GRAS), calcium phosphate is routinely used as an anti‑caking agent and nutrient fortificant.^[]

It has been approved for use in ready-to-eat chicken products, candy melts, doughnut sugar, and coated candy sugar.^[]

As far as safety is concerned, calcium phosphate serves as a calcium and phosphate source absorbed in the intestine. “Risk of systemic calcium or phosphate excess is negligible at permitted food-use levels; clinical concern low unless excessive dietary exposure occurs (eg, kidney disease),” Dr. Mohta explains.

Per FDA Commissioner Makary, “Now, by expanding the palette of available colors derived from natural sources, food manufacturers have a variety of options available that will make it easier to end their use of petroleum-based dyes.”^[]