On January 16, 2025, the Food and Drug Administration (FDA) made a significant move by revoking the color additive listing for Red Dye No. 3 in food and ingested drugs. This decision, which was published in the Federal Register, was a direct response to a petition filed by the Center for Science in the Public Interest (CSPI) and other stakeholders. The petition called for a ban on Red Dye No. 3 under the Delaney Clause of the Food, Drugs, and Cosmetics Act (FDCA), a clause that prohibits the use of any food additive found to cause cancer in humans or animals.
Red Dye No. 3, a synthetic food dye, has been a staple in the food industry since the early 1900s, imparting a bright, cherry-red color to various products. It has been used extensively in candies, cakes, cupcakes, cookies, frozen desserts, frostings, and some ingested drugs. Brands like Brach’s conversation hearts and TruMoo’s strawberry milk have relied on this dye to achieve their signature colors. However, despite its widespread use, Red Dye No. 3 has a complex history with regulatory bodies. It was permanently listed for use in foods and ingested drugs in 1969, but the FDA banned its use in cosmetics and topical drugs in 1990. This ban was due to concerns over potential carcinogenic effects, as studies had shown that high levels of Red Dye No. 3 caused cancer in laboratory male rats. Although the FDA acknowledged that the cancer in male rats was due to a rat-specific hormonal mechanism not present in humans, the Delaney Clause left little room for interpretation: any additive found to cause cancer in animals could not be used in food.
The FDA’s decision to revoke Red Dye No. 3 follows a long history of regulatory scrutiny. The color additive approval process, governed by the FDCA since 1960, requires manufacturers to submit a Color Additive Petition demonstrating the safety of their proposed additive. Red Dye No. 3 underwent this process and was permanently listed in 1969. However, in 1990, the FDA announced its intent to revoke the permanent listings for Red Dye No. 3 in food and ingested drugs under the Delaney Clause. Despite this announcement, the FDA did not take action at the time due to resource constraints, maintaining that available data did not raise safety concerns for humans.
The current ban, effective immediately, gives food manufacturers until January 15, 2027, and ingested drug manufacturers until January 18, 2028, to comply. This decision aligns with broader trends in food safety regulation. In 2024, the FDA banned the use of brominated vegetable oil, a controversial food additive. State-level legislation has also targeted food and color additives. California, for instance, became the first state to ban certain color additives, including Red Dye No. 3, with the passage of the California Food Safety Act in October 2023.
The implications of this ban are far-reaching. Food manufacturers will need to reformulate their products to find suitable alternatives to Red Dye No. 3. This could lead to changes in the appearance of popular foods and beverages, as well as potential shifts in consumer behavior. The ban also highlights the ongoing debate over the safety of synthetic food dyes and the need for transparency in food labeling. As the FDA continues to enforce stricter regulations, consumers can expect to see more natural and potentially safer alternatives in their food products.