On January 16, 2025, the Food and Drug Administration (FDA) revoked the color additive listing for use of Red Dye No. 3, a food dye that is used to color Brach’s Conversation Hearts and other popular candies. This decision was in response to a petition filed by the Center for Science in the Public Interest (CSPI) and other stakeholders to ban Red Dye No. 3 under the Delaney Clause of the Food, Drugs, and Cosmetics Act (FDCA). The Delaney Clause is a provision in the FDCA that deems any color additive found to cause cancer in man or animals as unsafe for any use that results in its ingestion. Specifically, the CSPI petition cited two studies that showed cancer in laboratory male rats exposed to high levels of Red Dye No. 3. Though the FDA did revoke the authorized uses for Red Dye No. 3 in food and ingested drugs to comply with the Delaney Clause, it maintains that available scientific information does not support that claim that ingested Red Dye No. 2 puts people at risk.
Red Dye No. 3 is considered a “color additive” under the FDCA. Color additives are defined as “a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic or to the human body,” and are considered useful by the FDA for providing a color consistency that helps consumers identify food products on sight. To be used in food, drugs, cosmetics, or medical devices, the FDCA requires that color additives be approved by the FDA. This is done through a Color Additive Petition that provides evidence that the additive is safe for the ways in which it will be used. Once the petition is approved, a regulation identifying the conditions of use is published in the Federal Register. When a color additive’s regulation is published, it is considered “permanently listed,” however, the FDA may “revoke or amend” the listings without undergoing the formal rulemaking process typically required for agency actions. Here, the FDA is revoking the regulations formally found at 21 CFR §§ 74.303, 1303 authorizing the use of Red Dye No. 3 for coloring in foods and ingested drugs.
Though Red Dye No. 3 has been in commercial use since the early 1900s, it was not permanently listed until 1969. The current petition process for color additives was created under the Color Additive Amendments of 1960, and following the update, all additives that were previously in commercial use were reevaluated for safety. Specifically, the color additives were provisionally listed and could only be used on an interim basis until they were either permanently listed or terminated. Thus, Red Dye No. 3 was provisionally listed in 1960 and stayed under that classification until it was proved safe through the petition process in 1969 and permanently listed for use in food and ingested drugs. In 1990, the FDA revoked Red Dye No. 3’s authorization for use in cosmetics and topical drugs under the Delaney Clause. Following that revocation, the FDA announced it would also revoke Red Dye No. 3’s authorization under the Delaney Clause for use in food and ingested drugs, but it never followed through. According to the FDA, “the agency decided not to take action at that time, given the resources required to remove this authorization,” but maintained that “available data does not raise safety concerns for humans.”
State level bans
The FDA banning Red Dye No. 3 follows several states proposing legislation that sought to ban food and color additives. Specifically, in October of 2023, California became the first state in the nation to ban the manufacture, distribution, and sale of foods and beverages containing certain color additives, including Red Dye No. 3. Following California’s passage of the law, several other states proposed food and color additive bans in 2024. Currently, at least six states have legislation introduced in their legislative sessions similar to California’s banning certain food or color additives. These states include New Jersey, Arkansas, Missouri, Oklahoma, New York, and Delaware. Additionally, in 2024, California passed the California School Food Safety Act prohibiting food with certain food and color additives from being sold in schools. So far, Texas, Hawaii, and Virginia have introduced similar legislation this session that seeks to ban the use of certain additives in food and beverages sold in schools. As most states are just beginning the 2025 legislative session, there might be more bills relating to these topics proposed in the coming months.
Next Steps for the Federal Ban
As the rule currently reads, food manufacturers who use Red Dye No. 3 in foods will have until January 15, 2027 to comply, while ingested drug manufacturers will have until January 18, 2028. The agency action banning Red Dye No. 3 was published in the last few days of the Biden administration. As such, its future under the Trump administration remains uncertain. The Trump administration has not spoken about its intentions regarding the issue, so the future of the Red Dye No. 3 ban remains unclear. Regardless, the conversation hearts are safe for this Valentine’s Day. To learn more about this issue, click here to read NALC article, “FDA bans Red Dye No. 3.”
Stone, Emily. “Be Mine: FDA bans food dye used in popular candies.” Southern Ag Today 5(7.5). February 14, 2025. Permalink
