FDA Bans Red Dye No. 3 in Foods

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FDA Bans Red Dye No. 3 in Foods
FDA took action to ban red dye No. 3 in food and drugs
FDA took action to ban red dye No. 3 in food and drugs. Credit: U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) announced Wednesday, January 15th, that it will ban the use of red dye No. 3 in foods, beverages, and certain medicines, citing long-standing concerns about its links to cancer in animals. The decision comes more than 30 years after studies first identified potential risks.

Red dye No. 3, or erythrosine, is a petroleum-derived synthetic additive that colors food, drinks, and medications red. Though banned in cosmetics and topical drugs, it remains in food due to the FDA’s past assessment dismissing its animal cancer risks for humans.

The recent action follows a 2022 petition from advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, which urged the FDA to revisit the dye’s safety. California had already banned red dye No. 3 in 2023, prompting calls for nationwide restrictions.

Compliance deadlines for manufacturers

“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” said Dr. Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, via email.

The decision marks a “monumental victory” for consumer health and safety,” said Ken Cook, cofounder and president of the Environmental Working Group, in a news release. “We wouldn’t be celebrating this historic decision today without the relentless leadership of public health champions like Michael Jacobson and others who took up this fight decades ago on behalf of consumers.”

NEWS: After 56 years, the FDA today officially banned the use of Red Dye No. 3 in foods and beverages in the US.

Food manufacturers will have until Jan. 15, 2027 to reformulate their products. 3,200 brand-name food products contain Red 3.

“The FDA cannot authorize a food… pic.twitter.com/WLt1O0BQp1

— Sawyer Merritt (@SawyerMerritt) January 15, 2025

Manufacturers using red dye No. 3 in food products must reformulate their recipes by Jan. 15, 2027. For ingested medicines, the deadline is Jan. 18, 2028. Imported products will also need to comply with these regulations.

Many major brands have already phased the dye out, although it is still found in some candies, drinks, and foods. Ferrara, the maker of Brach’s candies, said fewer than 10% of its products still use red dye No. 3. The company began removing the additive from its recipes in early 2023, according to a spokesperson.

Concerns about Red Dye No. 40

Advocates have also raised concerns about other synthetic dyes, including red dye No. 40, often marketed as a safer alternative. Although it has not been as strongly linked to cancer in animals, California banned its use in public schools in 2023 due to concerns about its effects on children’s behavior and attention.

Some studies have suggested red dye No. 40 may accelerate tumor growth in animals or contain benzene, a known carcinogen.

Red dye No. 3’s continued use in food has drawn criticism for decades. The FDA initially approved the additive in 1969, but it banned its use in cosmetics and skin-applied drugs in 1990 after animal studies found cancer risks. The agency, however, did not extend the ban to food, citing differences in how humans and animals metabolize the dye.

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