What to Know About the 2 Banned Food Dyes

How do the two synthetic food dyes the FDA plans to ban within months affect human health?

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It’s unlikely that you’d ingest either of the two synthetic food dyes—Citrus Red No. 2 and Orange B—that the U.S. Food and Drug Administration announced on April 22 it will ban in the coming months.

You’d only be at risk of the two dyes if you were to eat the peel of Florida oranges, which are often injected with Citrus Red No. 2 to make them more visually appealing to consumers, or if Orange B were currently produced—which it hasn’t been for decades.

“Because it was no longer produced, there was no need to actively ban it,” Bryan Quoc Le, a food scientist and food industry consultant, told The Epoch Times in an email. “The banning of these two dyes is fairly inconsequential.”

The FDA announced it would initiate the process of revoking authorization of Citrus Red No. 2 and Orange B as part of its plan to eliminate all remaining synthetic dyes from the food supply by the end of 2026.

The agency intends to work with the food industry to get all food dyes out of circulation.

Orange B

The FDA approved Orange B in 1966, with a limitation that it not exceed 150 parts per million in finished food. It was a colorant limited to hot dog and sausage casings and wasn’t permitted in cosmetics or medications.

Studies showed Orange B, an azo dye, was damaging to the spleens, livers, and kidneys in rats. The Center for Science in the Public Interest (CSPI) asked the FDA to officially ban it in its 2010 food dye report—more than 35 years after the single producer stopped making it due to carcinogenic concerns.

“In 1978 the FDA proposed banning Orange B (Fed Reg. October 3, 1978), but, because companies stopped using it, the FDA never bothered to finalize the ban; it should do so now,” wrote authors Sarah Kobylewski and Michael F. Jacobson.

Rupa Health notes that exposure to Orange B could include mild effects like skin reactions, hyperactivity, irritability, headaches, difficulty breathing, and gastrointestinal discomfort, such as nausea, vomiting, and diarrhea.

Citrus Red No. 2

Citrus Red No. 2 is also an azo dye, only approved at a level of no more than two parts per million for adding color to the skins of unprocessed Florida oranges. About 1,500 pounds—enough dye to color two billion oranges—are certified annually by the FDA.

“Citrus Red No. 2 is classified as ‘possibly carcinogenic to humans,’ which is why it is only allowed for orange peels that will not be eaten, and not for oranges that will be processed, which would release the dye into the edible portions, such as juice. Animal studies found that it can cause bladder tumors,” Quoc Le said.

A study of 100 mice fed diets containing Citrus Red No. 2 for 80 weeks found that those given the dye at 1 percent and 3 percent had increased illness and death. No effects were found at the lowest level of .03 percent.

Other studies have raised concerns about cancer, according to the CSPI report. Because the federal Food, Drug, and Cosmetic Act that governs toxicology levels for human health forbids any link to cancer in human or animal studies, the CSPI has long argued that Citrus Red No. 2 shouldn’t be used in food.

Some recipes call for cooking with grated orange peels, and the CSPI report noted experts’ concern about eating peels this way.

The CSPI report quoted an internal FDA memo written by FDA veterinarian Kent J. Davis saying, “Citrus Red 2 then becomes an intolerable human health hazard if only from the amounts consumed from fingers after peeling oranges treated with this dye. (Some additional dye may be ingested with peel or orange.)”

Plans for Bans

As early as the 1930s, azo-derived dyes were found to be directly carcinogenic to the liver and bladder in animals and humans. Azo dyes, which make up about 60 percent of food dyes, are synthetic colorants made with two nitrogen atoms bonded together with a carbon ring. Not only are the dyes used in food, but some are also used as colorants in fabrics and art supplies.

All food colorants—including natural ones, like those derived from beets, carrots, and turmeric—must be approved by the FDA. The nine synthetic dyes—Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, Citrus Red 2, Orange B, and Red No. 3—currently used must also be certified when a new batch is made, a process that ensures accurate measurements.

The FDA banned Red No. 3 in early 2025 with a grace period that expires Jan. 15, 2027, for food and Jan. 18, 2028, for medication. As part of the April 22 announcement, the FDA is asking companies to voluntarily remove Red No. 3 prior to the deadlines.

Future plans will include a timeline for phasing out synthetic dyes, the FDA said. It also announced it plans to authorize use of four new natural color additives within weeks, as well as accelerating the approval process to review other alternatives sooner.

But there are questions about how exactly RFK Jr.’s ban on food dyes will play out.

Susan Mayne, former head of FDA’s Center for Food Safety and Applied Nutrition during the Obama, Trump, and first two years of the Biden administration, says the ban is not really a ban. It cannot be enforced because it did not follow standard procedure. She said this week’s FDA announcement amounts to a call for voluntary action on the part of food makers.

“People were left very unclear in terms of what they are going to be doing,” she said.

“At the same time, there are state actions that are moving to ban products from coming into the state food supply or into school lunch programs.” Mayne said it is unclear how this federal approach will relate to the policies already being enacted at the state level.

Why Dye?

Florida resorted to dying their naturally pale oranges in the 1930s. By the 1950s, Florida opted to sell a large part of their harvested oranges to food manufacturers for use in concentrate—and those oranges cannot be tainted with dye. That’s why the FDA regulation on Citrus Red No. 2 is specific about its use for unprocessed oranges.

As a percentage of the total pounds of synthetic food dyes that the FDA certifies in batch tests every year, neither Orange B nor Citrus Red No. 2 register as a fraction of a percent.

Quoc Le said banning them is a sensible way to phase out all synthetic dyes.

“With few uses for these dyes, it’s much easier to remove them from the food system, as only a handful of applications exist and substitutions can be done quickly. These dyes are fairly low-hanging fruit.”