On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.¹ Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products. 

Background on Red No. 3 

Red No. 3, also known as erythrosine, is a petroleum-based color additive that provides the vivid and bright red hue – a cherry color – in many food and ingested drug products. This additive can be found in a variety of foods, including cakes, cupcakes, cookies, candies, icings, frostings, and certain ingested drugs, including cough syrup, vitamins, blood pressure medication and pain killers. 

FDA’s Regulation of Red No. 3

A food additive cannot be approved for use unless the data presented to the FDA establishes that the food additive is safe for that use.² The FDA has a notable history with Red No. 3. It was first approved for use in food in 1907 under the FD&C Act of 1906. In 1960, Red No. 3 was provisionally listed as Red No. 3 for food, drug, and cosmetic use.³ In 1969, it was permanently listed for use in food and ingested drugs⁴ and has since been codified as FD&C §§ 74.303 and 74.1303. 

In 1990, the FDA banned the use of Red No. 3 in cosmetics and externally applied drugs due to studies that showed it caused thyroid cancer in rats. However, the FDA did not revoke the listing for food and ingested drugs, until January 2025. 

FDA’s Revocation of Use and Reasons

In 2022, the Center for Science in the Public Interest and other consumer food and health groups, filed a petition requesting the FDA revoke its authorization of the use of Red No. 3 in food and ingested drugs due to its link to cancer in male lab rats exposed to high levels of the additive.

In January 2025, the FDA found the petition showed that Red No. 3 causes cancer in male laboratory rats exposed to high levels of the food and drug additive. As a result, the FDA concluded that the Delaney Clause of the FD&C Act, enacted in 1958, applied, requiring a prohibition of the additive. The Delaney Clause, codified as 21 U.S.C. § 379e and § 348(c)(3), states that a color or food additive is unsafe if the additive is found to induce cancer when ingested by man or animal. Courts have found that the Delaney Clause imposes a complete ban on additives found to induce cancer in humans or animals.

The FDA stated that the Delaney Clause prevents it from finding a food additive to be safe if it has been found to induce cancer when ingested by humans or animals, “regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action provide insight into the health effects of human consumption and use of the additive in question.”⁵ In other words, when scientific evidence shows that a food additive induces cancer in animals, the FDA will deem the food additive “unsafe” even if the risk of cancer is specific to the studied animal and poses little to no risk in humans. 

Because studies showed that FD&C Red No. 3 induces cancer in male rats, the FDA prohibited the use of the additive as “unsafe” as a matter of law. 

However, the FDA made clear that the studies showing Red No. 3 induced thyroid tumors in male rates are not relevant to humans. In fact, it concluded that “while studies show FD&C Red No. 3 induces thyroid tumors in male rats, the risk of developing such tumors in humans at low exposure levels from the current uses is unlikely.”⁶ This is because the mechanism by which Red No. 3 caused thyroid tumors in male rats is through an increase in circulating Thyroid Stimulating Hormone (TSH), to which rodents show a much higher sensitivity compared to humans. The FDA found no conclusive evidence demonstrating that increased TSH levels either promote or actively cause thyroid carcinogenesis in humans.

Other Bans and Legislation on Red No. 3

Red No. 3 is already banned for food use in Europe, Australia, and New Zealand, except in certain kinds of cherries. In 2023, California also banned the additive under the California Food Safety Act (AB418). The California ban was set to go into effect on January 1, 2027. Other states, including New York, Washington, Pennsylvania, and Illinois had legislation pending proposing a ban on Red No. 3 prior to FDA’s order. 

Key Takeaways

• Absent court intervention, food and ingested drug manufacturers using Red No. 3 must reformulate their products prior to January 15, 2027, or January 18, 2028, respectively.

• The FDA ban on Red No. 3 is not due to any carcinogenicity in humans. The FDA clearly noted that Red No. 3’s cancer-causing effect was not observed in humans. It also was not observed when tested in other animals, including female rats, mice of either sex, gerbils, or dogs. 

With the FDA’s revocation of the use of Red No. 3 in food and ingested drugs, litigation stemming from products containing the additive will likely follow. However, the FDA’s statement that Red No. 3’s cancer-causing effect was not observed in humans should be helpful in defending against any such litigation.

We are continuing to monitor updates and developments in this area.