FDA Bans Red No. 3 from Food and Drinks, Citing Cancer Risks

The U.S. Food and Drug Administration announced that it’s banning the controversial additive Red No. 3, a common food dye that appears in beverages, candy, snacks, and more.

“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in human or animals,” Jim Jones, the FDA’s deputy director for human foods, said in a statement, NBC News reports. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.”

The ban comes two years after the Center for Science in Public Interest petitioned the government to remove the additive, citing the health risks. The petition also noted that in 1990, the FDA banned its inclusion in cosmetics because it was deemed  “unsafe for use.”

However, it wasn’t banned from food because it “had already been permanently approved for use in food and ingested drugs.” The petition noted that the FDA said it would “take steps” to ban it, but at the time of the 2022 petition, “the agency has yet to delist FD&C Red No. 3 for these uses, and this carcinogen can still be found in foods, dietary supplements, and ingested drugs.”

“The FDA says it isn’t safe enough to put it on our cheeks, but it’s okay to put it in our mouths?” Lisa Lefferts, a scientist and consultant to Center for Science in the Public Interest, told the Washington Post.

In a statement announcing the ban, the agency wrote, “FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3.”

In its petition, CSPI noted that “there is widespread exposure to U.S. consumers, particularly children, and new information indicates that very young children have the highest exposures.” A search of for Red No. 3 — also called Red 3 or FD&C Red 3 — at the US Department of Agriculture’s site shows the ingredient in sprinkles, chips, milkshakes, candy, mini-muffins, and more packaged foods marketed to children.

Although parents claim Red No. 3 impacts children’s behavior — specifically, causing hyperactivity — in 2011 the FDA said a “casual relationship” could not be determined. However, for children who already had ADHD, that “condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, synthetic color additives.”

However, in 2012, a study published in the National Library of Medicine said food dyes “seem to affect children regardless of whether or not they have ADHD.”

In 2023, California banned the ingredient — which is already banned in the European Union. Ten other states have since followed suit.

As NBC News reports, food manufacturers have until Jan. 15, 2027 to adjust their products.

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