Red Alert: The Ban on Red No. 3 and Its Ripple Effect on Companies

On January 16, 2025, the U.S. Food and Drug Administration (FDA) published an order banning the use of Red No. 3 in consumable products. This artificial dye is currently used in a wide array of products, including food products such as candy, baked goods, soft drinks, and ice cream, as well as ingestible drugs. Companies that have long relied on Red No. 3 are required to reformulate by as soon as January 15, 2027 or the product will be considered adulterated. This ban could mark the beginning of a shift in safety standards in the food and drug spaces, and contribute to a trend of greater scrutiny of both new ingredients and ingredients in use in the marketplace.

This order comes as a response to a 2022 color additive petition spearheaded by the Center for Science in the Public Interest and other parties, proposing that FDA repeal the Red No. 3 regulations found at 21 CFR 74.303 and 21 CFR 74.1303 for foods and ingested drugs, respectively. Food manufacturers using Red No. 3 in their products will have until January 15, 2027 to reformulate products, while drug manufacturers using Red No. 3 will have until January 18, 2028 to reformulate their products in accordance with the order. Further, the order extends to foods and drugs imported to the U.S. after these dates, even if Red No. 3 is still allowed in the country of origin. FDA is accepting objections to the order and requests for a hearing on the order until February 18, 2025.

FDA’s basis for the revocation is the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits FDA authorization of a color additive if the additive has been found to induce cancer in humans or animals. The petitioners argued to FDA that Red No. 3 has been shown to induce cancer in male laboratory rats. However, FDA also found that testing conducted on other animals and humans did not similarly show these effects, and that claims that Red No. 3 in food and ingested drugs can similarly harm humans has not yet been supported by scientific evidence. Nonetheless, because the data provided by petitioners showed that Red No. 3 could induce cancer when ingested by an animal, FDA determined that the Delaney Clause applies.

The ban on Red No. 3 comes at a time when consumers care more than ever about “clean” ingredients and are demanding transparency regarding the products they ingest. It is also a part of heightened regulatory scrutiny of food products, generally. As discussed in our Advisories, FDA also recently published a proposed rule requiring front-of-package nutrition labels on most foods that bear a Nutrition Facts label. The rule follows the issuance of FDA’s new final rule defining “healthy” and the 2025 Dietary Guidelines Advisory Committee Scientific Report to the Secretaries of the U.S. Department of Health and Human Services and the U.S. Department of Agriculture recommending their updates to the U.S. Dietary Guidelines for Americans. All of these actions are expected to greatly influence how food is manufactured in the U.S. and what companies can or have to say about the food provided to consumers.

As the regulatory landscape continues to shift, it will be imperative that food and drug manufacturers continue to monitor regulatory trends in an effort to ensure a compliant product portfolio.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.