FDA Terminates The Use Of FD&C Red No. 3 In Food And Drugs Over Cancer Concerns

The FDA has decided to invalidate the approval for using FD&C Red No. 3, a synthetic red food dye, in food and ingested drugs. This decision follows the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the use of additives that have been shown to cause cancer in humans or animals. The change comes after a 2022 petition that pointed to studies showing FD&C Red No. 3 caused cancer in male rats exposed to high doses due to a rat-specific hormonal response. 

However, this mechanism does not apply to humans, and normal human exposure to the dye is far lower than the levels used in the studies. Research in other animals and humans has not found the same risks, and current science doesn’t support claims that the dye poses a significant cancer risk to people.

The Delaney Clause, which has been in effect since 1960, has led to similar actions in the past, such as the FDA’s 2018 revocation of certain synthetic flavourings. FD&C Red No. 3, often used to create a bright cherry-red colour, is found in some foods like candies, cakes, cookies, frozen desserts, and frostings, as well as certain ingested medications. However, it’s less commonly used compared to other colour additives.

Manufacturers have been given deadlines to remove FD&C Red No. 3 from their products until January 15, 2027, for food and January 18, 2028, for ingested drugs. While other countries still allow certain uses of the dye (known as erythrosine outside the U.S.), any foods imported to the U.S. must follow these updated rules.