The top line Following years of pressure from parents and health groups, one state prohibition, and action by dozens of other nations, the Food and Drug Administration has announced that it will outlaw the use of artificial food colouring Red No. 3, which has been connected to thyroid cancer in animals.
On January 15, the FDA declared a prohibition on the synthetic colorant Red No. 3, commonly known as Red 3, FC&C Red 3, or FD&C Red No. 3. This dye is frequently responsible for imparting a red hue to various foods, beverages, and certain medications. Initially, the FDA restricted the use of this dye, which has been associated with cancer in laboratory rats and potential behavioral problems in children, from cosmetics and topical treatments in 1990. Currently, the dye is prohibited in food items in the European Union, New Zealand, and Australia (with a notable exception for maraschino cherries) and faced a ban in California in 2023.
According to the FDA, “FD&C Red No. 3 has been mainly utilized in specific food products like candies, cakes, cupcakes, cookies, frozen desserts, and frostings and icings, in addition to certain oral medications.” Manufacturers of food products using Red No. 3 will have until January 15, 2027, to reformulate their offerings, while pharmaceutical companies will be given an extra year. Thus, for the moment, these items containing Red No. 3 will remain available.
Important Information
- Red Dye No. 3, which has been prohibited in cosmetics and externally applied medications for decades due to its association with thyroid cancer in animals, will no longer be used in food products or ingested medications, the FDA declared Wednesday.
- The restriction is applicable to all foreign-made items imported into the United States, and manufacturers who utilise Red No. 3 in food or medications will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products.
- In the past, the FDA had permitted the use of Red No. 3, also known as erythrosine, a petroleum-based colourant, in food in tiny quantities on an individual basis.
- California became the first state to restrict the sale of foods containing Red No. 3, and during that period, lawmakers in ten other states introduced legislation to do the same. The FDA has been considering a petition to ban the additive since 2022.
- The FDA reaffirmed its stance that the additive does not always pose a risk to humans even when it announced the ban, stating that the way the dye causes cancer in rats “does not occur in humans” and that human exposure levels to the dye are usually far lower than those of the studied rodents.
- If confirmed, President-elect Donald Trump’s choice for health secretary, Robert F. Kennedy Jr., has likewise promised to crack down on the use of food colours, alleging that they cause cancer and A.D.H.D. in children.
- In other countries, such as the European Union, where it is only permitted for use in cocktails and candied cherries, and Korea, where the use of most synthetic colours is forbidden in some foods consumed primarily by children and teens, Red No. 3 is subject to far stricter regulations.
In which foods is Red Dye 3 present?
The colour, which is still present in over 2,800 products on American markets, is most frequently found in candy, fruit juice, and other snack foods. According to the Environmental Working Group and the Centre for Science in the Public Interest (one of the petitioners seeking to ban the dye), some varieties of Fruit by the Foot, Dubble Bubble chewing gum, Entenmann’s Little Bites, Hostess’ Ding Dongs, Nestle strawberry milk, Jordan Almonds, Pez hard candies, Brach’s candy corn and some Ringpop flavours are among the products that have been listed as red 3 in recent years.
Red 3 is used in several of the house-brand products of grocery store companies Albertson’s, Kroger, Meijer’s, Target, and Walmart. The dye is also listed as an ingredient in Betty Crocker’s loaded mashed potatoes, Vigo saffron yellow rice, and Don Pancho green and blue tortilla chips.
The dye is referred to as Red 3, FD&C Red No. 3, or erythrosine. It is no longer permitted as a colour additive in meals, dietary supplements, or oral medications such cough syrups as a result of the ban. Because Red 3 was shown to cause cancer in rats, the FDA refused to approve its usage in cosmetics and topically applied medications more than thirty years ago.
According to Jim Jones, the FDA’s deputy commissioner for human foods, “the FDA is taking action that will remove the authorisation for the use of FD&C Red No. 3 in food and ingested drugs.” Male laboratory rats exposed to elevated amounts of FD&C Red No. 3 have been shown to develop cancer. Crucially, FD&C Red No. 3 does not cause cancer in humans in the same manner that it does in male rats.
Manufacturers of ingested medications have until January 2028 to remove the dye from their goods, while food manufacturers have until January 2027 to do so. While some uses of the dye are still permitted in other nations, imported foods must adhere to the new U.S. regulation.
Advocates for consumers applauded the ruling.
Dr. Peter Lurie, director of the organisation Centre for Science in the Public Interest, which spearheaded the petition movement, said, “This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy.”