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The U.S. Food and Drug Administration (FDA) has officially banned Red Dye No. 3 from food products, dietary supplements, and oral medications, a decision announced on January 15. This action concludes a decades-long debate surrounding the dye, which has faced criticism for its potential health risks, particularly its link to cancer in laboratory animals.
The ban comes nearly 35 years after the FDA previously prohibited the use of Red 3, also known as erythrosine or FD&C Red No. 3, in cosmetics and topical drugs due to evidence that linked it to cancer in male rats. Food manufacturers now have until January 2027 to phase out the dye, while producers of ingested drugs have until 2028 to comply with the new regulations.
The decision was informed by the Delaney Clause, a statute that prohibits any food additive found to cause cancer in animals or humans. The FDA has noted that while there is no direct evidence tying Red 3 to cancer in humans, studies have shown the dye’s carcinogenic effects in high doses in animals.
Health advocates and lawmakers have largely welcomed the ban, viewing it as a necessary step to protect children, who are the primary consumers of products containing the dye. Critics of the dye have pointed out the inconsistency in its regulation, noting that it has been banned from cosmetics but remained legal in food products.
As food manufacturers prepare to remove Red 3, many are already transitioning to natural alternatives such as beet juice, red cabbage, and purple sweet potato pigments. This shift reflects a growing consumer demand for cleaner ingredients and aligns with similar bans in other countries, including those in Europe, Australia, and New Zealand.
Consumer attitudes have increasingly favored stricter regulations on food additives. Recent polling indicates that approximately two-thirds of U.S. adults support reformulating processed foods to eliminate harmful ingredients, with heightened support among college-educated and higher-income demographics.
The FDA’s decision to ban Red Dye No. 3 marks a significant, if overdue, victory for food safety advocates. While debates about the dye’s safety may persist, this action signals a broader trend in the food industry toward prioritizing health and safety over aesthetic considerations.
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