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FDA bans use of Red dye No. 3 in food and drugs

Candy-1307567_640More than 30 years after the U.S. Food and Drug Administration determined that the synthetic food dye Red No. 3 causes cancer, the agency is revoking the use of the dye in food and ingested drugs in response to a 2022 petition.

The petition, filed by the Center for Science in the Public Interest and 23 other organizations and scientists, asked the agency to review whether the Delaney Clause, which prohibits FDA authorization of a food or color additive if it’s been found to induce cancer in humans or animals, applied.

In 1990, based on evidence from the 1980s that Red 3 caused cancer in laboratory animals, the FDA prohibited the dye from use in cosmetics and topical drugs and said it would “take steps” to ban it from foods and ingested drugs. However, the agency hadn’t taken action until Wednesday.

“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,” CSPI president Peter G. Lurie, M.D., said 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 FDA said in its announcement that the way that Red dye No. 3, also known as erythrosine and FD&C Red No. 3, causes cancer in male rats doesn’t occur in humans. Relevant exposure levels to Red dye No. 3 for humans are typically much lower than those that cause the effects shown in male rats, according to the agency. 

However, the petitioners pointed to long-established evidence that the dye causes thyroid cancer when consumed by animals. The petition stated the FDA had previously rejected arguments by the food industry that Red No. 3 was only dangerous after it exceeded a certain threshold, an assertion that has never been backed up with evidence.

Red dye No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. It’s been used in food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as some ingested drugs. 

Manufacturers who use Red dye No. 3 in food will have until Jan. 15, 2027, to reformulate their products. The date for ingested drugs is Jan. 18, 2028. Other countries that still allow for uses of Red dye No. 3, called erythrosine in other countries, will be required to comply with U.S. requirements.

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