• The FDA has banned Red Dye No. 3, also known as erythrosine, from food and drugs due to evidence linking it to cancer in lab rats.
• This decision follows a petition filed in 2022 by consumer advocacy groups calling for a review of the dye's safety.
• Food manufacturers will have until January 2027 to remove the dye from their products; drug manufacturers have until January 2028.
• This ban aligns U.S. regulations more closely with stricter international standards in Europe and Australia.
• The move is seen as a response to growing concerns over food safety and children's health.

The US Food and Drug Administration (FDA) has officially banned the use of Red Dye No. 3 in food, beverages, and oral medications, citing evidence that links the synthetic dye to cancer in laboratory rats. This decision, announced on January 15, 2025, comes nearly 35 years after the dye was banned from cosmetics due to similar health concerns. The ban follows a 2022 petition from various consumer advocacy groups, including the Center for Science in the Public Interest, which urged the FDA to reconsider the dye's safety in everyday products.

The FDA designated this action as a “matter of law”, referencing the Delaney Clause, which mandates the ban of any food or color additive demonstrated to cause cancer in either humans or animals. In its statement, the FDA noted, “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” Despite this assertion, health advocates emphasized the importance of consumer safety, particularly for children who disproportionately consume products containing color additives.

The much-criticized dye, which has been utilized to enhance the appearance of candies, cakes, and several medications, will have a grace period allowing manufacturers until January 15, 2027, to reformulate food products and until January 18, 2028, for ingestible drug products to comply with the ban. Items that previously contained the dye include popular foods like strawberry-flavored beverages, certain candies, and baked goods. Notably, some companies have already begun replacing Red 3 with alternative natural colorings such as beet juice and other plant-derived pigments.

This regulatory change aligns the US with international standards, as Red 3 is already banned in the European Union, Australia, and New Zealand, with exceptions made only for certain products like maraschino cherries. Consumer groups have praised the FDA’s action as a long-overdue correction to a regulatory inconsistency that allowed a carcinogenic substance in food while prohibiting its use in cosmetics.

Nevertheless, the dye's ban might face legal challenges from food manufacturers since evidence remains inconclusive about its carcinogenic effect on humans. “When we do ban something, it will go to court,” stated FDA Commissioner Dr. Robert Califf, regarding the legal prospects of enforcement. The International Association of Color Manufacturers defended the safety of Red 3, suggesting that consumption levels typically seen satisfy established safety criteria.

As the FDA enforces this ban, it raises broader questions about the regulation of food additives in the United States, with increasing pressure from consumers and health advocates for transparency in the ingredients used in common food items. This move follows ongoing conversations about food safety reform and the need for rigorous testing of food colorings and additives commonly found in food products available to children.

For the original articles and more details, you can visit BBC, The Guardian, and Los Angeles Times.