In a significant move, the U.S. Food and Drug Administration (FDA) has announced that it will revoke the authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3, in food and ingested drugs due to concerns over its potential cancer-causing effects. The FDA’s decision, set to take effect on January 15, 2025, marks a shift in regulatory policy for the synthetic food dye that has been widely used to color candies, baked goods, frozen desserts, and medications.
The decision comes after new data presented in a 2022 petition showed that high levels of FD&C Red No. 3 caused cancer in male laboratory rats. While studies in other animals and humans did not demonstrate the same effects, the FDA is acting under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This clause prohibits the FDA from approving food or color additives that have been shown to cause cancer in humans or animals.
FDA officials clarified that while there is no evidence linking FD&C Red No. 3 to cancer in humans, the agency is revoking the authorization for its use in food and ingested drugs as a precautionary measure. Manufacturers of products containing the dye will have until January 15, 2027, to reformulate their food products, and until January 18, 2028, to reformulate drugs. Consumers may still encounter products containing FD&C Red No. 3 if they were manufactured before the enforcement deadline.
The decision follows a series of regulatory actions over the years regarding the safety of FD&C Red No. 3. In the 1990s, the FDA initially proposed revoking its approval for use in food and drugs due to cancer concerns observed in animal studies but chose not to act at that time. However, the agency’s latest ruling reflects growing concerns about the potential risks associated with the dye.
FD&C Red No. 3 is a synthetic colorant used to give foods and medications a bright cherry-red hue. It has long been featured in products such as candies, cakes, cupcakes, and certain over-the-counter drugs. Under the new ruling, manufacturers will be required to remove the dye from their products, and it will no longer be allowed in food and drug applications.
As the FDA continues to monitor and regulate food additives, manufacturers are also reminded that they are responsible for ensuring the safety and compliance of their products under FDA regulations.
FDA Officially Bans Use of Red Dye No. 3 in Food Products Following Cancer Concerns
