FDA Bans Red No. 3: What Companies Need to Know

On January 15, 2025, The Food and Drug Administration (“FDA”) issued an Order banning the use of Red No. 3 (a/k/a Red Dye No. 3, Red Dye 3, FD&C Red No. 3, and erythrosine), a synthetic food dye that adds a bright, cherry-red color to certain foods. The color additive is a petroleum-based dye and is found in hundreds of products including candies, cakes, cupcakes, cookies, frozen desserts, vegan “meats,” chewing gum, gummy vitamins, and cough syrup. 

 

Red No. 3 has been used in food products since 1907, with FDA approval.  However, the FDA banned Red No. 3 from cosmetics and topical drugs in 1990 after research found increased cancer rates among rodents who consumed the dye.  The FDA’s expansion of the ban to the food industry comes after nearly thirty-five years of dedicated efforts by parents and health advocates, as well as the enaction of a state ban in California (effective January 2027)[1].  

 

In 2022, the Center For Science in the Public Interest and twenty-three other organizations and prominent scientists petitioned the FDA following a review of data that showed Red No. 3 caused cancer in male laboratory rats. The cancer was attributed to a “rat specific” hormonal mechanism  that occurs in male rats, but not humans. The FDA analyzed the data presented by the petitioners and ultimately revoked Red No. 3’s authorization based on the Delancey Clause of the Federal Food, Drug, and Cosmetic (“FD&C”) Act. The Delancey Clause, enacted in 1960 as Section 409(c)(1)(A) of the Color Additives Amendment to the FD&C, prohibits FDA authorization of a food or color additive if it has been found to induce cancer in humans or animals. In its Order, the FDA concluded that: 

 

"[t]he Delaney Clause applies because FD&C Red No. 3 has been found to ‘induce cancer when ingested by . . . animal.’ Specifically, some in vivo studies have shown FD&C Red No. 3 can induce thyroid tumors in male rats. . . . The language of the Delaney Clause is straightforward. Under the general safety clause for color additives, FDA has discretion to review a number of factors to determine whether a color additive is safe (section 721(b)(5)(A) of the FD&C Act). However, for ingested color additives that are shown “to induce cancer in man or animal,” the Delaney Clause limits FDA's discretion and requires that FDA conclude that the color additive is not safe as a matter of law." 

 

The Order provides a January 15, 2027 deadline for food manufacturers to comply, while drug manufacturers have until January 18, 2028 to reformulate their products.   

 

Red No. 3 was first set to be removed from food products in 1992, following the FDA’s review of the rodent study cited in the 2022 Petition. According to the FDA, it decided not to act at that time, “given the resources required to remove [the] authorization.”[2]  

 

While some manufacturers have outwardly voiced their commitment to complying with the 2025 Order, including Kellanova, the manufacturer behind Pop-Tarts and MorningStar products, we anticipate backlash from segments of the food and drug industry that heavily utilize Red No. 3 because (as the FDA admits in the Order) there is no clear link to cancer in humans from this additive. Other manufacturers, including Just Born, the maker of the candy “Peeps,” previously announced it would discontinue the coloring in pink and lavender Peeps  after Easter 2024. 

 

Under 21 U.S.C. § 348, food additives are only allowed if regulated  by the FDA. Products with unapproved additives are considered "adulterated" and can be seized by the FDA. Companies continuing to sell products with Red No. 3 could risk financial losses and production disruptions.

 

The FDA is currently accepting objections to the Order and requests for a hearing related to the Order until February 18, 2025.