The FDA revoked authorization for FD&C Red No. 3 in food, dietary supplements and ingested drugs. Food and supplements have until January 15, 2027, to comply; ingested drugs have until January 18, 2028. The decision rests on cancer findings in male rats and the Delaney Clause—not on evidence that typical human consumption has been shown to cause cancer. The FDA says the rat-specific mechanism does not occur in humans and that available evidence does not show Red No. 3 causes cancer in people.
What the FDA’s order covers
The FDA’s January 15, 2025, order revoked authorization for FD&C Red No. 3 as a color additive in food and ingested drugs. The food category includes dietary supplements. The rule applies to products sold in the United States, including imports, which must meet U.S. requirements. Some other countries continue to allow certain uses; the dye may be called erythrosine there. FDA: FD&C Red No. 3
This is a specific action against Red No. 3, not a ban on all synthetic food dyes. FDA discusses broader color-additive reformulation separately in its July 2025 manufacturer letter. FDA’s July 14, 2025, letter
When products must comply
| Product type | Compliance date |
|---|---|
| Food and dietary supplements | January 15, 2027 |
| Ingested drugs | January 18, 2028 |
These dates remain in place following the FDA’s August 5, 2026, response to objections and requests for a hearing, which ended an administrative stay of the order. The agency reaffirmed the original dates. Federal Register: response to objections and hearing requests
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A compliance date does not mean every affected product disappears from shelves that day. The FDA says consumers may still encounter products containing Red No. 3 after the applicable date if those products were manufactured before it. The agency encouraged food manufacturers in July 2025 to phase out the color as soon as practicable, ahead of the food deadline.
Why the FDA revoked authorization
The legal basis is the Delaney Clause, which bars authorization of a food or color additive if it is found to induce cancer in humans or animals. A 2022 color-additive petition cited two studies in which male laboratory rats developed cancer after exposure to high levels of FD&C Red No. 3. The FDA relied on those animal findings in applying the law; it did not conclude that ordinary human consumption had been shown to cause cancer.
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That distinction matters. The FDA says the mechanism behind the rat findings is specific to rats and does not occur in humans. It also says relevant human exposures are typically much lower than the exposures that produced the effects in rats, and that studies in other animals and humans did not show those effects. The agency’s stated position is that available scientific information does not show Red No. 3 in food or ingested drugs puts people at risk of cancer. The FDA materials cited here provide no numerical estimate of human cancer risk or numerical comparison of typical exposure with the rat-study levels. FDA: FD&C Red No. 3
Jim Jones, then FDA Deputy Commissioner for Human Foods, summarized the agency’s legal and scientific explanation in January 2025: “The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” FDA Roundup: January 17, 2025
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Where Red No. 3 has been used and how to check a label
The FDA describes Red No. 3 as a bright cherry-red color used in some candies, cakes and cupcakes, cookies, frozen desserts, frostings and icings, and some ingested drugs. It says the dye is less widely used than some other certified colors. Those categories are examples, not a current list of brands, and they do not establish that a particular product still contains the dye.
- For packaged food in the United States, read the current ingredient statement.
- Look for “FD&C Red No. 3,” “FD&C Red 3,” or “Red 3.” FDA says added color additives must be declared.
- Check the package again when buying later. Formulas can change, so an old online ingredient list may not match the current product.
The FDA’s color-additive database lists regulatory status, but a listing there is not a substitute for checking an individual package’s ingredients. FDA: Regulatory Status of Color Additives
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What reformulation can involve
Manufacturers may replace Red No. 3 with other authorized colors, develop new color additives, or consider colors from sources such as plants. The FDA says every color additive, regardless of its source, must meet the legal safety standard for its intended conditions of use. The agency’s phase-out guidance is not an endorsement of any particular retail food coloring or replacement product. FDA’s July 14, 2025, letter
Quick Recap
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- Eye-Catching Color Premium blends add vivid, rich, fade-resistant, true-to-shade colors that are made specially for your baking and cake decorating. Our assortment of soft gel food coloring includes a rainbow of hues from neon, pastel, primary, and more. Mix our gels for a seemingly limitless color palette!
- Infinite Applications Let your creativity flow with colored icings, fondants, gum pastes, batters, cake frostings, and more. Amuse your kids with bright blue pancakes, join in the process of making slime, arts and crafts.
- Quality Ingredients Liqua-Gel food coloring is gluten-free, certified kosher, vegan-friendly, and halal. Our professional grade formula provides the tint you want without altering the taste, texture, or consistency of your finished baked goods.
- Highly Concentrated Liqua-Gel Each drop provides high impact, vibrant color. With a flip top lid and no-drip squeeze bottle, you can easily control the number of drops added.
- Manufactured in the USA With over 85 years of experience in coloring food products and overall, 120 years in the bakery industry, we pride ourselves on formulating blends to meet your one-of-a-kind creations. Our Chefmaster collection is made in Fullerton, CA.
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