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FDA Bans Red Dye No. 3 From Food Products More Than 30 Years After Banning It From Cosmetics

The U.S. Food and Drug Administration (FDA) has banned the use of red dye no.3 in food products, after first banning the petroleum-based synthetic color addictive from cosmetics over 30-years ago due to its links to…

Andrew Powell·Jan 15, 2025·3 min read

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The U.S. Food and Drug Administration (FDA) has Banned the use of Red dye no.3 in food products, after first banning the petroleum-based synthetic color addictive from cosmetics over 30-years ago due to its links to cancer.

The agency announced Wednesday that it will be banning the use of the product from food, beverages, and ingestible drugs like Tylenol.

“The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” the announcement reads, “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, two studies that were included in the petition’s filings showed high concentrations of the dye caused cancer in male lab rats, but the agency goes on to say claims made that state the dye causes cancer in humans, are “not supported by the available scientific information.”

The announcement further notes Red dye no.3 is primarily used in food products like cakes, cupcakes, frozen desserts, candy, and frosting, giving the food a bright red cherry color. Food manufacturers will have until January 15, 2027, or January 18, 2028, to reformulate their products and phase the dye out, while imported foods will have to meet new U.S. requirements.

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According to a report from CNN, the Environmental Working Group (EWG) along with a number of other public health groups filed the petitions to the FDA in 2022. In a statement on the ban, the EWG notes the use of Red dye no.3 has been Banned for use in cosmetics since 1990 due to it causing cancer in rats.

“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,” EWG President and co-Founder Ken Cook said in a statement, “We all owe a debt of gratitude to Michael and the other early leaders who pushed the FDA to remove toxic chemical ingredients from the nation’s food supply.”

While the FDA has said the dye does not cause cancer in humans, other research as noted by the EWG has suggested its use in food products are having a profoundly negative effect on children who ingest it.

A 2021 study by California’s Office of Environmental Health Hazard Assessment found “adverse neurobehavioral outcomes” in children, and that the FDA’s recommended daily intake was outdated.

“Overall, human studies indicate that synthetic food dyes are associated with adverse neurobehavioral outcomes in children, and that children vary in their sensitivity to synthetic food dyes,” the study’s summary reads, later adding, “Researchers also found that all of the FDA’s Acceptable Daily Intake levels (ADIs) for synthetic food dyes are based on 35- to 70-year-old studies that were not designed to detect the types of behavioral effects that have been observed in children.”

FDA Bans Red Dye No. 3 From Food Products More Than 30 Years After Banning It From Cosmetics — IJR