US FDA Bans Red No 3 Dye Due to Cancer Risk

Jan 15, 2025 at 9:56 PM

The United States Food and Drug Administration (FDA) has issued a ban on the synthetic dye known as red No 3, commonly used to impart a vivid cherry-red color to various food items and beverages. This decision comes in response to studies that have shown a potential link between the dye and cancer in male laboratory rats. While human exposure levels are generally lower than those tested in animals, US regulations mandate a prohibition if any cancer risk is identified. The dye's widespread use in products like candies, cakes, cookies, frozen desserts, frostings, and certain medications prompted this action. Advocacy groups, including the Center for Science in the Public Interest, have long petitioned for its removal, citing concerns over its impact on public health, particularly among children.

In a significant development, the FDA announced on Wednesday that manufacturers must cease using red No 3, which was previously banned in cosmetics 35 years ago. California also enacted a similar ban on the additive in food products last October. Internationally, countries such as Australia, New Zealand, and members of the European Union have already restricted its use. Dr. Peter Lurie, president of the Center for Science in the Public Interest, welcomed the decision, noting that it resolves a long-standing inconsistency where the dye was prohibited in lipsticks but allowed in foods consumed by children. Manufacturers now have until January 2027 to reformulate their food products, with drug manufacturers having an additional year to comply.

The dye has been a common ingredient in a variety of popular snacks and beverages, including colored candies, toaster pastries, maraschino cherries, and fruit-flavored drinks. It has also been used in pharmaceuticals like cough syrups and gummy vitamins to achieve a vibrant red hue. Some companies, recognizing the growing health concerns, have already begun phasing out red No 3. For instance, Dole removed it from its fruit bowls in 2023. As alternatives, manufacturers are turning to red dye 40, though this substitute has raised its own set of health questions. Studies have linked red dye 40 to increased bowel disorders in mice and heightened hyperactivity in children, leading to its ban in California schools.

The FDA's decision marks a pivotal moment in consumer safety, addressing long-standing concerns about the potential risks associated with artificial food additives. The move not only aligns with international standards but also responds to advocacy efforts aimed at protecting vulnerable populations, especially children. By providing a clear timeline for compliance, the FDA ensures that both domestic and imported products will adhere to the new regulations, fostering a safer environment for consumers.