US FDA Prohibits Red Dye No. 3 in Foods and Medications by 2027

Jan 16, 2025 at 12:30 PM

The U.S. Food and Drug Administration (FDA) has announced a ban on the use of red dye No. 3 in foods and medications, effective January 2027. This decision follows growing concerns about potential health risks associated with the additive, including cancer and behavioral issues. The ban is part of broader efforts to enhance food safety and protect public health. Advocacy groups have long petitioned for stricter regulations on this controversial coloring agent.

Understanding the Health Risks Behind the Ban

The decision to prohibit red dye No. 3 stems from significant research indicating its potential adverse effects. Although studies primarily focus on animal models, there are concerns that high doses may lead to cancer. Additionally, experts highlight links between the dye and behavioral problems in children. While direct human evidence remains inconclusive, precautionary measures are being taken under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This clause mandates that any substance shown to cause cancer in animals or humans cannot be approved for ingestion. Even though human studies haven't conclusively linked red dye No. 3 to cancer, the FDA adheres to strict guidelines to safeguard public health. Moreover, mounting evidence suggests that the dye can contribute to hyperactivity and other behavioral challenges, particularly in young individuals. Dr. Jamie Alan, an expert in pharmacology and toxicology, emphasizes the clarity of data regarding its impact on behavior, especially among children.

Impact on Products and Consumer Actions

Red dye No. 3, also known as erythrosine, has been prevalent in various processed foods and medications. Common items containing this additive include baking decorations, ice cream cones, frostings, frozen dairy desserts, soft candies, meal replacement drinks, cookies, toaster pastries, ice pops, baby foods, and hard candy. Despite the ban, immediate recalls are unlikely, according to food safety expert Darin Detwiler. Companies will need to comply by the set deadlines but can continue selling existing stock until then.

The FDA has established a transition period: food manufacturers must remove the dye by January 15, 2027, while drug manufacturers have until January 18, 2028. Imported goods must also meet these standards. Consumers who prefer products with red dye No. 3 can still purchase them for the next two years. However, this move is widely seen as a positive step towards safer alternatives. Dr. Alan commends the FDA's decision, noting that modern technology offers numerous safe dye options, eliminating the need for potentially harmful additives like red dye No. 3.