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

The Food and Drug Administration has officially prohibited the use of Red No. 3, a food and beverage coloring substance that produces a bright, cherry-red color.

filed in 2022 by advocates who claim the additive is linked to cancer and behavioral issues in children.

Manufacturers who use Red No. 3 in food will have until January 15, 2027, to reformulate their products, while those who use the dye in drugs will have until January 18, 2028, as stated in the FDA’s announcement. Yankee-made foods brought into the country will also have to comply with the new regulations.

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Here is what to know about Red No. 3 and the effects that have been reported about it.

What is known as Red No. 3?

A US charity concentrating on environmental and public health issues, over 3,000 products contain Red No. 3.

Red Number 3 was outlawed in U.S. cosmetics in 1990 due to findings that the dye causes cancer in laboratory rats at high doses. Despite this, it has remained one of nine synthetic dyes still cleared for use in foods. The eight other approved dyes include Blue Number 1, Blue Number 2, Green Number 3, Orange B, Red 40, Yellow 5, Yellow 6, and Citrus Red − all used to give food, drinks, and medicinal products their bright colors.

Why was Red No. 3 banned by the FDA?

A color additive petition filed in 2022 cited two studies indicating that high levels of Red No. 3 caused cancer in male lab rats. However, the FDA statement noted that the process by which Red No. 3 causes cancer in lab rats is not applicable to humans. Additionally, human exposure to Red No. 3 is typically lower than that of lab rats. The announcement stated that studies with other animals and humans did not produce similar effects.

There has been a nationwide federal ban put in place, following a similar ban implemented in California.

California became the first US state to ban the manufacture, sale, or distribution of four food additives, including Red No. 3, in 2023.

A separate law passed in 2024 has California planning to prohibit the use of six out of the nine FDA-approved artificial food dyes in public school food and drinks by 2027. The bill did not include the restriction of Red No. 3.

As more states have followed suit, bills targeting the use of food additives have been introduced, including those in Illinois and New York.

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Is there a global ban on Red No. 3?

Yes, Red No. 3 is largely prohibited in the European Union, Australia, and New Zealand.

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FDA bans Red No. 3 food dye from food, drinks: Here’s what you need to know