FDA bans Red No. 3 food dye in food, drinks: Here's what to know

The FDA has officially banned Red No. 3, a coloring agent that was used to make foods and beverages have a bright, cherry-red color.

filed in 2022 by advocates who claim a potential link between the additive and cancer, as well as behavioral issues in children.

Manufacturers that use Red No. 3 in food will have until January 15, 2027, to reformulate their products, while those that use the dye in drugs will have until January 18, 2028, according to the FDA announcement, including imported foods sold in the U.S. will also have to meet these new rules.

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Here's what you should know about Red No. 3 and its reported effects.

What is Red No. 3?

A US-based nonprofit that focuses on environmental and public health issues has found more than 3,000 products contain Red No. 3.

In 1990, Red No. 3 was outlawed for use in cosmetics in the U.S. due to research showing that it can cause cancer at high doses in laboratory rats. Yet, it's still one of nine man-made dyes permitted for use in food items. The remaining eight dyes included in the approval list are Blue No. 1, Blue No. 2, Green No. 3, Orange B, Red 40, Yellow 5, Yellow 6, and Citrus Red − all used to give foods, beverages, and medications vibrant colors.

What led to the FDA's decision to ban Red No. 3?

An application was filed in 2022 to license an added color. The application referenced two studies that found a link between high levels of Red No. 3 and cancer in male lab rats. The FDA stated that the mechanism by which Red No. 3 causes cancer in male lab rats does not occur in people. Additionally, it was noted that people are generally exposed to lower levels of Red No. 3 compared to the lab rats. The announcement also stated that other studies involving other animals and humans did not produce these effects.

Federal ban follows similar one imposed in California.

California became the first U.S. state in 2023 to ban the production, sale or distribution of four food dyes, including Red No. 3.

A separate act passed in 2024 had California aiming to ban six of the nine FDA-approved artificial food dyes from school food and drinks by 2027. The bill specifically excluded Red No. 3 from the ban.

As more states have joined in, Illinois and New York are among them, with bills that target the use of food additives.

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Is Red No. 3 banned in other countries?

Yes. Red No. 3 is largely banned in the United States, Canada, the European Union, Australia, and New Zealand.

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