The Food and Drug Administration has revoked approval of Red No. 3 for use in food and drinks, starting January 15, 2027. The cherry-red pigment is derived from petroleum and is commonly used in candy.

The decision comes after a review triggered by years of requests from consumer advocacy groups and is based on the Delaney Clause of the Federal Food, Drug and Cosmetic Act. This clause prevents the FDA from finding a color additive to be safe if it has been found to induce cancer in humans or animals at any dose. According to the FDA, two studies showed cancer in laboratory male rats exposed to high levels of the pigment, although studies in other animals and in humans did not show these effects. 

  • Most color additives, including Red No. 3, require pre-market review and approval by the FDA, and its use is permitted only from batches that the FDA has tested and certified.
  • The FDA prohibited use of this pigment in cosmetics more than 30 years ago.
  • Red No. 3 is already banned or restricted in Australia, Japan and several European countries.
  • Many products already use the alternative Red No. 40.

Consumer advocates have long pushed for a ban of Red No. 3 in food and drinks, including Robert F. Kennedy Jr., President-elect-Donald Trump’s nominee for secretary of the Department of Health and Human Services, which oversees the FDA. Several U.S. states have taken steps to ban the dye due to growing concerns about potential adverse health and behavioral impacts. 

Prohibiting use of Red No. 3 removes an unnecessary hazard from the American food supply, says Dr. Peter G. Lurie, president of the Center for Science in the Public Interest, a food safety group that petitioned the FDA in 2022 to end its approval of the colorant. “The primary purpose of food dyes is to make candy, drinks and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”

This could be helpful news for promo, says Rick Brenner, MAS+, president of Product Safety Advisors and a past PPAI Board chair. “Aside from eliminating the obvious cancer risk and the controversy that has surrounded Red Dye No. 3 – documented in rats but not conclusive in humans – FDA’s decision to phase out and ban this additive helps our helps our industry by aligning with restrictions in place in Australia, Japan, the European Union and California,” he says. “The lack of consistency and harmonization of regulations between countries – particularly the U.K., E.U. and U.S. – has always made compliance and testing more complicated for importers dealing with factories in Asia and elsewhere.”

David Miller, president of NC Custom (PPAI 111662, Silver), purveyor of candies, cookies and other treats and PPAI 100’s No. 71 supplier, says the company has already been working on collecting information about which items may contain Red No. 3 in order to comply with California’s Food Safety Act.

“By the end of Q2, we should have all materials identified that contain the banned ingredients and reformulations in progress as needed to fully address” the issue, he adds.

For questions or suggestions on regulatory or government affairs issues, please contact Rachel Zoch at RachelZ@ppai.org.