The U.S. Food and Drug Administration (FDA) has revoked the authorization for the use of FD&C Red No. 3 in food and drugs, based on the Delaney Clause, which prohibits the use of additives that cause cancer.
This synthetic food dye, which gives a cherry-red color to products such as candies and cakes, will be removed from food by January 2027 and from drugs by January 2028. The decision responds to a 2022 petition, supported by studies showing a link between this dye and cancer in male rats exposed to high levels of the compound.
Although other countries still allow its use, imports to the U.S. must comply with FDA regulations. Exporters of products containing this dye should stay informed about the agency’s updates, using strategic intelligence studies and regulatory analysis to comply with the new regulations.
