FDA Takes Action to Ban Red Dye No. 3, but not Canada

The U.S. Food and Drug Administration (FDA) recently announced a significant decision to revoke the authorization of FD&C Red No. 3 (commonly known as Red 3) as a colour additive in foods, dietary supplements, and ingested drugs. This long-awaited move stems from mounting evidence that high levels of the synthetic dye caused cancer in male laboratory rats. The decision has prompted a closer look at how food additive regulations compare between the U.S. and Canada, with noticeable differences in their approaches.

In January 2025, the FDA declared its intention to prohibit the use of Red 3 in consumable products, citing carcinogenic risks associated with the dye. Manufacturers have until January 15, 2027, to remove the dye from foods and dietary supplements, and until January 18, 2028, for ingested drugs. The FDA’s action aligns with the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of additives found to cause cancer in humans or animals.

Red 3 has been widely used in products like candies, baked goods, and medications due to its bright cherry-red hue. Although the FDA initially banned its use in cosmetics and topical drugs back in 1990, this latest action extends the prohibition to ingestible items. Advocacy groups like the Center for Science in the Public Interest (CSPI), which spearheaded the petition for this ban, have lauded the decision as a step toward stronger consumer protection.

However, the FDA acknowledges that the risk to humans is minimal, asserting that typical exposure levels are much lower than those causing cancer in lab animals. Despite this, the precautionary measure underscores a commitment to adhering to regulatory principles and mitigating potential risks.

Canada’s Stance on Erythrosine: A Regulated Yet Permitted Additive

While the U.S. is phasing out Red 3 in foods and drugs, Canada takes a different stance. Health Canada allows the use of erythrosine, the technical name for Red 3, as a food colourant under strict regulations. Listed as E127 in the Canadian Food Inspection Agency’s (CFIA) database, the dye is permitted at specified levels, with a maximum combined concentration of 300 parts per million (ppm) when used with certain other dyes.

Health Canada has determined that erythrosine poses no significant health risk to Canadians when consumed within the established limits. This position is based on comprehensive assessments that evaluate both exposure levels and scientific data. Consequently, Red 3 continues to be approved for use in various food products in Canada, provided manufacturers adhere to the prescribed guidelines.

The FDA’s decision to ban Red 3 highlights a more precautionary approach, prioritizing even minimal potential risks linked to food additives. In contrast, Canada’s stance reflects confidence in scientific assessments and controlled usage to ensure consumer safety.

Consumer advocacy groups have praised the FDA’s move as a corrective step, emphasizing that additives primarily used for aesthetic purposes should not carry cancer risks, no matter how small. “At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick but perfectly legal to feed to children in candy,” said CSPI president Peter Lurie, M.D.

Meanwhile, industry representatives in both countries are working to adapt. The National Confectioners Association in the U.S. has committed to compliance, emphasizing food safety as a top priority. Similarly, Canadian food manufacturers continue to operate within stringent guidelines set forth by Health Canada and the CFIA.

As the FDA’s ban sets a precedent, it raises questions about the future of food additive regulations worldwide. With consumer awareness growing and scientific scrutiny intensifying, global harmonization of food safety standards may emerge as the next frontier in regulatory policy.

The FDA’s prohibition of Red 3 marks a significant shift in U.S. food safety policy, while Canada maintains its approval under controlled conditions. These contrasting approaches underscore the balance between precaution and permissible risk, with implications for manufacturers, regulators, and consumers alike.