U.S. food, drug makers have 2 to 3 years to remove banned Red No. 3 from products

By Rebekah Hall

U of A System Division of Agriculture

LITTLE ROCK — The Food and Drug Administration has revoked use of the synthetic dye Red No. 3 — approved to provide color in food and drugs since 1969 — but is giving U.S. food manufacturers and drug companies two to three years to remove it from their products.

The Jan.15 ban comes in response to a 2022 petition that requested the FDA review studies that showed cancer in male lab rats exposed to high levels of Red No. 3. It addition to food and medication, it has been used in cosmetic items such as hair dyes.

Quad Whitson, extension culinary nutrition program associate for the University of Arkansas System Division of Agriculture, said the FDA revoked the use of Red No. 3 in food and drugs due to the Delaney Clause, part of the Federal Food, Drug and Cosmetic Act.

“The clause explicitly prohibits the use of any chemical that is found to cause cancer in humans or animals based on carcinogenic testing,” Whitson said. “Data presented by the FDA in 2022 showed that in large doses, Red No. 3 had the potential to cause cancer in male lab rats due to its effects on processes that control the release and action of hormones in the body of male rats.”

Red No. 3 is primarily used in food products, such as candy, cakes, cupcakes, frozen desserts and frostings, as well as some ingested drugs.

Whitson explained that “revoking” the use of something like a food additive “means that you are formally taking away the privilege to use an additive that was previously allowed.” He said Red No. 3 was initially approved for food in the United States in 1969.

Complex process

The ban on Red No. 3 immediately affects food imported from other countries. Manufacturers in the United States will have until Jan. 15, 2027, to remove the dye from food products, and until Jan. 18, 2028, to remove it from drug products.

Whitson said these deadlines are extended “due to the complex process of product reformulation.”

“Changing a product’s recipe can be lengthy, due to the extensive testing required to ensure that the new product or products maintain the desired taste, texture and functionality of the original product,” Whitson said. “They want to ensure they can maintain customer satisfaction despite the changes.”

There is not an official comprehensive list or resource that details all the food and drug products that contain Red No. 3, which Whitson said is due to the “difficulty of capturing every new and pre-existing food or drug product on the market containing the dye.”

Read the label

“If consumers aim to remove products containing Red No. 3 from their households and dietary patterns, the best way to do so is to review the ingredients of food labels,” Whitson said. “Under current FDA food labeling regulations, certified color additives must be made known to consumers.”

The color additive No. 3 can appear in the following ways on the ingredients of a food label:

•FD&C Red No. 3

•FD&C Red 3

•Red 3

Learn more about food safety on the Cooperative Extension Service’s website or contact Whitson at qwhitson@uada.edu.