February 06, 2025
On January 15, 2025, the FDA revoked authorization for food and drug manufacturers to use Red No. 3 in food and ingested drugs. This synthetic dye gives food and drinks a bright, cherry-red color. The revoke is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits use of a food or color additive if it has been found to induce cancer in humans or animals. Data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3; however, studies in other animals or in humans did not show the same effect. There is also no evidence showing FD&C Red No. 3 causes cancer in humans.1
While manufacturers who use this dye have until January 18, 2028, to reformulate their products, PAI Pharma is pleased to share that more than 60 products in our portfolio do not contain this additive. Many of the products in our expansive and diverse portfolio also avoid attributes like alcohol, gluten, lactose, preservatives, and sugar. To see all the “free from” products we offer, click here.
Reference: 1. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. January 15, 2025. https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs#:~:text=January%2015%2C%202025,cancer%20in%20humans%20or%20animals.