The US Food and Drug Administration (FDA) has revoked its authorisation for the use of FD&C Red No. 3 dye in food and ingested drugs.
The synthetic dye, used in candies, cakes, and some medications, was linked to cancer in laboratory rats.
This ban by the FDA follows its previous ban on its use in cosmetics more than 30 years ago.
The regulator has banned the dye under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), following a 2022 colour additive petition.
The petition requested the FDA to review the application of the Delaney Clause, citing studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.
However, the cancer mechanism in rats is specific to that species and does not occur in humans.
Human exposure to FD&C Red No. 3 is much lower, and studies in other animals and humans did not show similar effects.
Current scientific information does not support claims that FD&C Red No. 3 in food and ingested drugs poses a risk to human health.
The Delaney Clause, part of the 1960 Color Additives Amendment to the FD&C Act, prohibits FDA authorisation of any food or colour additive found to cause cancer in humans or animals.
In 2018, the agency revoked approval for certain synthetic flavours following a food additive petition.
FDA Human Foods deputy commissioner Jim Jones, has been quoted by Reuters, as saying: “The FDA cannot authorise a food additive or colour additive if it has been found to cause cancer in humans or animals.”
FD&C Red No. 3 is a synthetic dye used to give foods and drinks a bright, cherry-red colour.
The health regulator estimates that it is less widely used in food and drugs compared to other certified colours.
It has primarily been used in products like candy, cakes, cupcakes, cookies, frozen desserts, frostings, and certain ingested drugs.
Manufacturers using Red No. 3 in food must reformulate by 15 January 2027, and ingested-drug makers by 18 January 2028, to comply with the order. While other countries still allow certain uses of FD&C Red No. 3, the law mandates that foods imported to the US to meet its regulations.
In a separate development, the health agency has proposed reducing nicotine to minimally or nonaddictive levels in cigarettes and certain other combusted tobacco products.
