Red dye No. 3 now banned; consumer groups applaud FDA’s action
The Food and Drug Administration this week banned the use of Red Dye No. 3 in foods, meeting requirements of the 1960 Delaney Clause of the Food, Drug and Cosmetic Act.
The action comes after years of public requests for the FDA to take action against harmful chemicals added to foods. In 1990 the agency banned the use of Red No. 3 in cosmetics, but had not taken similar action for foods and drugs until this week.
“The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition,” according to the FDA announcement about the ban.
The petition, filed by the Center for Science in the Public Interest (CSPI) and more than 20 other organizations, cited studies that have shown that Red No. 3 causes cancer in animals and causes behavioral and developmental problems in children.
In October 2024 Consumer Reports delivered a separate petition to the FDA, signed by more than 80,000 consumers, asking the agency to ban Red No. 3.
The Delaney Clause, referenced by the CSPI petition, specifically calls for the FDA to ban the use of food additives that have been shown to cause cancer in animals or humans.
The FDA announcement said Red No. 3 is primarily used in foods and drinks marketed to children, including candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, and sodas. Children are more susceptible to the dangers of the food additive because of their small body weight in comparison to the amount of the additive they consume.
Red Dye No. 3 is a synthetic dye made from petroleum that gives food and drinks a bright, cherry-red color. It was banned in 1990 by the FDA from use in cosmetics after it was shown to cause cancer in lab rats. At the time, the FDA indicated that it would take steps to ban Red Dye 3 in food, but never followed through. Red Dye 3 has already been banned by the European Union and was recently prohibited in food sold in California starting in 2027. The food and drug industries in the United States used more than 200,000 pounds of Red 3 in 2021.
According to the Environmental Working Group, nearly 3,000 food products on the market today contain Red Dye No. 3, including many artificially flavored and artificially colored candy marketed to children. While Red Dye 3 poses risks to people of all ages, young children may be most vulnerable because of their small body weight and higher levels of exposure, according to Consumer Reports.
Manufacturers who use Red No. 3 in food and ingested drugs will have until Jan. 15, 2027 or Jan. 18, 2028, respectively, to reformulate their products. Foods imported to the U.S. must comply with U.S. requirements.
Support from U.S. Rep Rosa DeLauro
Congresswoman Rose DeLauro, D-CT, applauded the FDA’s action.
“There is no reason that a dye that has been banned in many products, including cosmetics, for thirty years should be in our food supply,” DeLauro said.
“I have long called for action on largely unregulated additives and chemicals in our foods, and I applaud the FDA and the Biden Administration for acting to protect Americans’ health and eliminate this dangerous carcinogen from foods. Much work remains to be done, but the American public will be safer now that we are removing this dye from our foods, supplements, and drugs.”
Reaction from the Center for Science in the Public Interest
In 2022, the center (CSPI) filed its petition with the FDA asking the agency to ban the use of Red No. 3. The CSPI was joined by 23 other organizations in submitting the petition.
“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,” said CSPI president Peter G. Lurie. “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?”
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. But the agency failed to fulfill that commitment, according to a statement from CSPI. That commitment was finally met this week.
The CSPI petition highlighted how FDA had previously rejected arguments by the food industry that Red 3 was only dangerous after it exceeded a certain threshold, an assertion which has never been backed up with evidence.
“We’re not surprised FDA has asserted that the risk is small, since it’s a chemical they failed to ban for years, and they want to reassure the public that the agency hasn’t been placing them at risk for decades,” Lurie said, “But the truth is Congress made plain decades ago that this was exactly the type of chemical — one that causes cancer in animals — it was trying to keep out of the U.S. food supply.”
CSPI’s advice to parents is to avoid not only Red 3, but all numbered dyes, such as Yellow 5 and Red 40. Aside from the risk of cancer posed by Red 3, concerns have mounted about the adverse impacts of these synthetic dyes on children’s behavior.
Reaction from Consumer Reports
Consumer Reports was one of the consumer protection groups that signed on to the petition filed by the CSPI seeking to make Red No. 3 illegal.
“Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available,” said Brian Ronholm, director of food policy at Consumer Reports. “By banning Red Dye 3, the FDA will protect the public by encouraging manufacturers to switch to safer ingredients already used in products sold in Europe and numerous other countries.”
In October 2024 Consumer Reports delivered a separate petition to the FDA, signed by more than 80,000 consumers, asking the agency to ban Red No. 3. This week the organization initiated another petition drive calling on the FDA to take action against other synthetic food dyes.
“Many synthetic food dyes are allowed in food but haven’t been reviewed for safety by the FDA in decades despite recent studies that have linked the chemicals to serious health problems,” said Ronholm. “It’s time for the FDA to catch up with the latest science and get these harmful chemicals out of our food.”
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