US govt bans red dye No. 3 from food, drinks and ingested drugs after scientists discovered links to cancer
The US Food and Drug Administration has officially prohibited the use of red dye No. 3 in food, drinks, and ingestible medications, marking a significant step more than three decades after research revealed its potential cancer links in animals. This announcement was made on Wednesday, January 15.
Red dye No. 3, a synthetic color derived from petroleum and scientifically referred to as erythrosine, is commonly used to impart a vibrant cherry-red hue to various food and beverage products.
This decision stems from a petition filed in November 2022 by several advocacy groups and individuals, including the Center for Science in the Public Interest and the Environmental Working Group, who highlighted the dye’s association with cancer risks. Additionally, this action aligns with California’s recent ban on the additive, which took effect in October 2023.
According to the FDA, manufacturers utilizing red dye No. 3 in food products have until January 15, 2027, and those using it in medications have until January 18, 2028, to reformulate their offerings. Furthermore, imported foods entering the United States must also adhere to these new regulations.
“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.
Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either never used, or have already stopped using, the additive.
Fewer than 10% of products made by the candy company Ferrara, which produces Brach’s candies, for example, contain the additive, as the company began phasing out the use of it in early 2023, a Ferrara spokesperson said via email.
Some companies opt for red dye No. 40, which is viewed as a healthier choice since it has not been as closely linked to cancer in animals.
Red dye No. 3 remains allowed in food products, even with the Delaney Clause of the FDA’s Federal Food, Drug, and Cosmetic Act. This clause states that the FDA cannot approve a color additive for consumption if it is known to cause cancer in animals or humans when ingested.
In 1990, the U.S. FDA prohibited the use of red dye No. 3 in cosmetics and topical medications under the Delaney Clause after studies indicated that the dye could be carcinogenic at high doses in rats. However, the specific mechanism that led to cancer in rats does not apply to humans, which is why the FDA did not withdraw its approval for red dye No. 3 in food products, as per the agency’s findings.
The FDA has reevaluated the ingredient’s safety multiple times since its initial approval — based on trials conducted in animals, not humans — in 1969, according to the agency.
There don’t appear to be any studies establishing links between red dye No. 3 and cancer in humans, and “relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the FDA said in its constituent update posted Wednesday.
“Claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
But 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,” said Dr. Jennifer Pomeranz, associate professor of public health policy and management at New York University’s School of Global Public Health.
