Bye-Bye Red Dye! FDA Finally Bans Red No. 3 Food Coloring in U.S.

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Bye-Bye Red Dye! FDA Finally Bans Red No. 3 Food Coloring in U.S.

The FDA has banned the red dye that is linked to cancer in lab animals. 

The Food and Drug Administration has banned Red No. 3, a synthetic dye used to give foods their bright, cherry coloring.

The announcement came Wednesday morning after the FDA announced that the product was linked to cancer in lab animals. According to the Center for Science in the Public Interest, it is a carcinogen, a natural or synthetic substance, organism, or agent that can cause cancer.

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“The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition,” the FDA said in a statement. “The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat-specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”

While the dye only caused cancer in animals, the ingredient is still found in hundreds of foods, including strawberry-flavored Ensure, the cherries in fruit cocktail, and many varieties of candy corn.

“The Delaney Clause is clear; the FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals,” Jim Jones, the FDA’s deputy commissioner for human foods, told CBS News. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”

The decision came after a petition filed by the CSPI, who called for the additive to be pulled from the market.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said CSPI president Dr. Peter G. Lurie in a statement. “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?”

The history of red dye in the United States is lengthy. In 1960, Congress made clear that it wanted no cancer-causing dyes in the food supply – not even in small amounts, also known as the Delaney Cause. In September of 2024, California became the first state to ban six harmful food dyes in school food, with Red No. 3 being included.

Colorful dyes have also been linked to health effects in children. According to the Environmental Working Group, food dye may aggravate symptoms associated with behavioral difficulties, including inattentiveness, impaired memory and restlessness. Colors such as Red No. 40, Yellow No. 5 or Yellow No. 6, which account for 90 percent of food dyes used in the U.S.,  are especially linked to those health effects.  Food dyes can affect gut bacteria, according to a study from Ohio State University, which can worsen anxiety in children. Due to its cancerous effects on humans, Red No. 3 has also been banned in the use of cosmetics.

“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework,” a spokesperson for the National Confectioners Association told NBC News. “We have been saying for years that FDA is the rightful national regulatory decision maker and leader in food safety.”

According to the FDA, manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products.

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