FDA Bans Red Food Dye No. 3 from Foods and BeveragesFDA Bans Red Food Dye No. 3 from Foods and Beverages
FDA officials granted a 2022 petition filed food safety and health advocates who urged the agency to revoke authorization for the dye, which gives some candies, snack cakes, and more their bright red color.

The US Food & Drug Administration on Wednesday banned food dye Red #3 from the nation’s food supply and ingested rugs, nearly 35 years after it was barred from cosmetics because of potential cancer risk.
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some candies, snack cakes, maraschino cherries and more their bright red color.
The agency said it was taking the action as a “matter of law” because some studies have found that the dye caused cancer in lab rats. Officials cited a statute known as the Delaney Clause, which requires FDA to ban any additive found to cause cancer in people or animals.
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. In 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.
The dye is called erythrosine, FD&C Red No. 3 or Red 3. It is usually listed as FD&C Red 3 on packaging labels. The ban removes it from the list of approved color additives in foods, dietary supplements, and oral medicines, such as cough syrups.
More than three decades ago, the FDA declined to authorize use of Red 3 in cosmetics and externally applied drugs because a study showed it caused cancer when eaten by rats. Why it took this long to pass the law to omit the dye from foods and beverages is something FDA hasn't addressed.
“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
Food manufacturers have three years, until January 15, 2027, to remove the dye from their products and reformulate them, while makers of ingested drugs have until January 18, 2028. Other countries still allow for certain uses of the dye, but imported foods must meet the new US requirement.
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