On January 15, 2025, the FDA issued an order revoking the authorization for FD&C Red No. 3 in food and in ingested drugs, meaning medicines you swallow. It has not disappeared yet. The order gives food makers until January 15, 2027 and drug makers until January 18, 2028 to reformulate, so for now a medicine can still legally contain it. Here is what changed, why, and how to check a medicine yourself instead of waiting for the deadline.
What did the FDA actually do?
FD&C Red No. 3, also called Red Dye 3 and erythrosine, is a synthetic dye that gives products a bright, cherry-red color. Acting on a 2022 color additive petition, the FDA amended its color additive regulations so that Red No. 3 will no longer be allowed in foods, including dietary supplements, or in ingested drugs. The order was issued on January 15, 2025, with two compliance dates:
- Food, including dietary supplements: January 15, 2027.
- Ingested drugs: January 18, 2028.
For a while, those dates were on hold. Objections filed against the order put it under an administrative stay in February 2025. On August 5, 2026, the FDA announced that the objections did not justify a hearing, lifted the stay, and confirmed both deadlines.
The FDA also points out that a product made before its deadline could still be on the market after it. So the deadline is when manufacturers must stop using the dye, not the day every bottle containing it leaves the shelf.
Why was Red No. 3 revoked?
The legal basis is the Delaney Clause, part of the 1960 Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act. It prohibits the FDA from authorizing a food or color additive that has been found to induce cancer in humans or animals. The petition cited studies showing cancer in male laboratory rats exposed to high levels of Red No. 3, and that finding triggered the clause. The FDA says it is revoking the authorization as a matter of law.
The FDA was also direct about human risk. It stated that the way Red No. 3 causes cancer in male rats is a hormonal mechanism that does not occur in humans, that human exposure is typically much lower than the levels that caused the effect in rats, and that studies in other animals and in humans did not show the same effect. In the agency’s words, claims that its use in food and ingested drugs puts people at risk are not supported by the available scientific information.
The same clause had already shaped the dye’s history. In 1990 the FDA denied a request to permanently authorize Red No. 3 in cosmetics and topical drugs, and in 1992 it announced an intention to revoke the food and ingested-drug uses, then did not act at that time.
What it means for your medication
The FDA estimates that Red No. 3 is not as widely used in food and drugs as other certified colors, but it is used in certain ingested drugs. Until January 18, 2028, a medicine you swallow can still contain it, and stock made before that date may still be around afterward. If you would rather avoid it now, you do not have to wait: check the label, and ask your pharmacist whether a version without it is available. Do not stop taking a medicine on your own because of a dye; review it with your pharmacist or prescriber first.
The dates that matter
What about Red 40 and the other synthetic dyes?
On April 22, 2025, HHS and the FDA announced measures to phase out petroleum-based synthetic dyes from the nation’s food supply. Among them: working with industry to eliminate six other synthetic dyes, including FD&C Red No. 40 and Yellow No. 5, from the food supply “by the end of next year” (meaning the end of 2026), and asking food companies to remove Red No. 3 sooner than the existing deadline. In July 2025 the FDA followed up with a letter encouraging food manufacturers, including dietary supplement makers, to finish removing Red No. 3 before January 15, 2027.
The April announcement does not mention medicines, and the July letter’s request to move faster covers foods and supplements, not drugs. Red No. 40 remains listed in FDA color additive regulations for coloring drugs, and it is a different dye from Red No. 3, so seeing Red 40 on a label does not mean the product contains Red No. 3.
A dye that is fully allowed can still matter to someone sensitive to it. FD&C Yellow No. 5, for example, must be declared on the labels of drugs taken by mouth and certain other routes, and prescription labeling must warn that it can cause allergic-type reactions in susceptible people. Our guide to dyes in medication covers the full picture, and our titanium dioxide guide covers the white colorant with a regulatory story of its own.
How to check a medicine for Red No. 3
- Read the inactive ingredients for “FD&C Red No. 3.” The same dye is called erythrosine in Canada and Europe, and food labels may shorten it to “Red 3.”
- Check vitamins and supplements too. Dietary supplements follow the food deadline, January 15, 2027.
- For prescriptions, ask the pharmacist, who can check the full product information for the exact version you are given.
- Ask for a dye-free version if you want to avoid dyes altogether. Your pharmacist can tell you what is available.
- Keep checking after the deadlines, since product made earlier can still be on shelves.
- Check the product with the app. The AllergenMeds app flags ingredients like these in the exact product you look up. For choosing medicine for a child, see our parent’s guide to allergy-safe medication.
Common questions
Is Red Dye No. 3 banned in medicine?
It is on its way out, but not gone yet. On January 15, 2025, FDA issued an order revoking the authorization for FD&C Red No. 3 in food and ingested drugs. Drug makers have until January 18, 2028 to reformulate medicines that are swallowed, so until then a medicine can still legally contain it. Objections put the order on hold in 2025, and in August 2026 FDA lifted the hold and confirmed both deadlines. FDA also notes that products made before the deadline may still be on the market after it.
Why did the FDA revoke Red No. 3?
Because of the Delaney Clause, a 1960 provision of federal food and drug law that prohibits FDA from authorizing a color additive found to cause cancer in humans or animals. Studies showed cancer in male laboratory rats exposed to high levels of Red No. 3. FDA stated that the way it causes cancer in male rats does not occur in humans and that there is no evidence it causes cancer in people, but the Delaney Clause directs FDA to find such uses unsafe, so the agency revoked the authorization as a matter of law.
Is Red 40 banned too?
No. Red No. 40 remains authorized for coloring drugs under FDA color additive regulations. In April 2025, HHS and FDA announced a plan to work with industry to eliminate six synthetic dyes, including Red No. 40 and Yellow No. 5, from the food supply. That announcement is about food; it does not mention medicines.
How do I know if my medicine contains Red No. 3?
Check the inactive ingredients for FD&C Red No. 3. The same dye is called erythrosine in Canada and Europe. For an over-the-counter medicine the list is on the Drug Facts label; for a prescription, ask your pharmacist to check the product information, and ask whether a version without it is available.
When do vitamins and supplements have to stop using Red No. 3?
Dietary supplements fall under the food deadline in FDA’s order, January 15, 2027. In July 2025, FDA also encouraged food manufacturers, including supplement makers, to finish removing Red No. 3 before that deadline.
Sources
- FDA: FD&C Red No. 3 (regulatory information and history)
- FDA: FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs (January 15, 2025)
- FDA: HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply (April 22, 2025)
- Federal Register: FDA response to objections, stay lifted and Red No. 3 deadlines confirmed (August 5, 2026)
- 21 CFR 74.1340: FD&C Red No. 40 listed for coloring drugs (eCFR)
This guide is for education only, not medical advice. Always talk to your doctor or pharmacist before starting, stopping, or switching any medication.