The U.S. Food and Drug Administration (FDA) has announced a landmark decision to ban Red Dye No. 3, also known as erythrosine, from foods, beverages, and ingested drugs. This decision follows a petition urging the FDA to reassess the safety of this widely used additive. The ruling invokes the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits food additives found to induce cancer in humans or animals.
Red Dye No. 3 is recognized for imparting a vivid cherry-red hue to a variety of products, including candies, cakes, cookies, and frozen desserts. Despite its vibrant coloration, the dye is not as prevalently used as other food colorants, according to the FDA. The move comes after studies linked Red Dye No. 3 to cancer in male lab rats, though such effects have not been observed in other animals or humans.
"The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans," stated the FDA.
The cancer-causing effects noted in male rats were associated with extremely high doses of the dye, levels far exceeding what humans typically consume. Despite these findings, the Delaney Clause mandates that if an additive shows cancer potential in animals or humans, it must be kept out of the food supply.
"It doesn't matter, because the FDA mandate under the Delaney Clause says that if it shows cancer in animals or humans, they're supposed to keep it from the food supply," commented Jennifer Pomeranz.
The FDA's decision arrives as a legal mandate, and U.S. food manufacturers have until January 2027 to reformulate their products to exclude Red Dye No. 3. Drug manufacturers will have a slightly longer timeline, with a deadline set for January 2028. Additionally, products imported into the United States must adhere to this ban. This regulatory change follows a historical precedent; back in 1990, Red Dye No. 3 was prohibited in cosmetics and topical drugs due to safety concerns.
The Environmental Working Group (EWG), a significant advocate for the dye's ban, has expressed concerns regarding potential health risks associated with erythrosine. They have played a crucial role in pushing for this regulatory review and subsequent ban.
