Food makers must drop Red No. 3 by January 2027: the FDA's 2025 order, confirmed in 2026

On January 15, 2025, the Food and Drug Administration announced that it was revoking the authorization for FD&C Red No. 3, a synthetic dye used to color foods and drinks cherry red, in food and in ingested drugs. The order was published in the Federal Register the next day, January 16, 2025. It applies across the United States, imported foods included, and sets two deadlines: January 15, 2027, for food, including dietary supplements, and January 18, 2028, for ingested drugs.

The FDA acted on a 2022 petition from the Center for Science in the Public Interest and other groups. It cited the Delaney Clause, a 1960 provision of federal food and drug law that bars the agency from authorizing a color additive found to cause cancer in humans or animals. Studies cited in the petition found cancer in male rats given high levels of the dye in the laboratory. The FDA announced the filing of the petition in the Federal Register on February 17, 2023, and the public comment period on it closed on May 18, 2023.

The agency stresses what that finding does not show. It says the dye causes cancer in male rats through a hormonal mechanism specific to rats, and that the effect was not seen in studies of other animals or of people. Claims that the dye puts people at risk "are not supported by the available scientific information," the FDA said. In its order, it put the highest estimated exposure from the approved uses at 0.25 milligrams per kilogram of body weight a day, compared with 35.8 milligrams for the level at which no adverse thyroid hormone effects were seen in male rats. Under the Delaney Clause, the finding in rats still makes the dye unsafe "as a matter of law," the order says.

Where the dye is used

By the FDA's estimate, Red No. 3 is used less widely than other certified colors. Its main uses have been in candy, cakes and cupcakes, cookies, frozen desserts, frostings and icings, and some ingested drugs. Its use in cosmetics and externally applied drugs already ended in 1990, when the FDA did not extend a provisional listing for those uses because of the rat studies.

Food labels must name it: the FDA requires manufacturers to list the dye in the statement of ingredients. Under the FDA's labeling rules, the dye is declared in the ingredient list as "FD&C Red No. 3", "FD&C Red 3" or "Red 3". Other countries allow some uses under a different name: in Canada and Europe it is called erythrosine. Foods imported into the U.S. must still meet U.S. requirements, the FDA says.

How the order was challenged and confirmed

The order gave anyone adversely affected until February 18, 2025, to file objections and ask for a hearing. The FDA received one submission, filed on behalf of Micro-Tracers, Inc. It disputed the FDA's statistical reading of the rat data and argued, among other points, that the agency had not considered the use of the dye in color-coded tracers for animal feed. Under the law, filing objections automatically stayed the order.

On August 5, 2026, the FDA overruled the objections, denied the requests for a public hearing and lifted the stay. It found that the objections did not raise issues of material fact that would justify a hearing, and it confirmed the original deadlines of January 15, 2027, and January 18, 2028.

What applies now

Until January 15, 2027, the dye remains authorized in food. Each batch must be certified by the FDA, and only certified batches may carry the name FD&C Red No. 3. After each deadline, FDA certificates for existing batches of the dye stop being valid for that use, and using it would make a food or drug adulterated. Food and drugs that were colored with it while its certificate was still valid are not treated as adulterated for that reason, and the FDA says consumers could see Red No. 3 in products on the market after the deadlines if they were made before them.

Federal officials have also asked companies to move faster. On April 22, 2025, the Department of Health and Human Services and the FDA announced a plan to phase out petroleum-based synthetic dyes and asked food companies to remove Red No. 3 sooner than the 2027-2028 deadlines. The FDA's page on the dye, marked current as of October 5, 2026, still gives January 15, 2027, and January 18, 2028, as the dates by which manufacturers must reformulate.

The FDA's consumer line is 1-888-INFO-FDA (1-888-463-6332).