FDA Under Pressure to Address Nationwide Ban on Red Dye in Food

by Ella

In the wake of California’s recent legislation banning synthetic food coloring Red No. 3, the Food and Drug Administration (FDA) is facing mounting pressure to take comprehensive action on this issue, amid concerns raised by public health advocates regarding its potential impact on public health.

California, in an unprecedented move, became the first state to prohibit the use of four food additives, including Red No. 3. This significant development has spurred nationwide efforts by public health advocates to advocate for the removal of this dye from the entire U.S. food supply. Dr. Peter Lurie, the president and executive director of the Center for Science in the Public Interest, highlights the implications of this new legislation, stating, “I think the passage of the bill in California creates undeniable pressure on the FDA.”


Last October, Dr. Lurie’s organization, in conjunction with other consumer advocacy groups, including the Public Interest Research Group and the Consumer Federation of America, lodged a petition with the FDA, urging the agency to ban the use of Red No. 3. Dr. Lurie believes that California’s groundbreaking action may facilitate the granting of their petition by the FDA.


The history of Red No. 3 is fraught with controversy. In 1990, the FDA suspended its use in cosmetics and externally applied drugs due to a study suggesting it could induce cancer in rats. However, the FDA permitted its continued use in food products, and Red No. 3 subsequently became a ubiquitous ingredient in the U.S. food supply. Over the years, numerous studies have linked synthetic dyes to behavioral issues in children, notably hyperactivity.


Dr. Lurie emphasizes the urgency of the situation, stating, “For 33 years now, we have been waiting for the FDA to take common sense action that would remove [Red No. 3] from the market and thereby better protect American consumers.”


Synthetic food dyes, including Red No. 3, are employed to provide vivid and appealing colors to foods, rendering them more visually enticing. The National Confectioners Association’s Christopher Gindlesperger asserts the importance of these vibrant colors, especially within the confectionery industry. Red No. 3 is not limited to candies but can also be found in various foods and beverages, including brightly colored sodas, juices, yogurts, snacks, and frozen desserts.

However, Gindlesperger expresses concerns about the consequences of the California ban, set to take effect in 2027, as it could lead to a patchwork of state regulations that may raise food costs and cause confusion among consumers, particularly parents.

The National Confectioners Association calls upon the FDA to utilize its regulatory authority to address the issue and determine whether Red No. 3 should continue to be used in food products. In a letter to the FDA, the organization contends that California is not equipped to set national food safety standards and emphasizes that the FDA is best positioned to provide the necessary guidance to food companies.

California’s Environmental Protection Agency conducted a review of synthetic dyes, revealing evidence that these dyes, when consumed in food, could have adverse effects on children’s behavior. More than half of approximately 25 studies examined demonstrated a positive correlation between artificial food coloring intake and behavioral outcomes.

Furthermore, the review uncovered a higher consumption of synthetic dyes in lower-income communities and among Black Americans, underscoring disparities in exposure to these additives. Asa Bradman, a public health scientist at the University of California, Merced, asserts the importance of a precautionary approach. He points out, “I think there is good reason to remove [Red No. 3] from the food supply.”

Research supports this view, with one double-blinded study involving children aged 3 to 9 demonstrating that the consumption of synthetic dyes led to increased hyperactivity.

Mark Miller, a scientist with California’s EPA’s Office of Environmental Health Hazard Assessment, contends that the evidence from human studies strongly suggests that the consumption of synthetic food dyes can contribute to symptoms like inattention and hyperactivity in some children.

The FDA, in response to these mounting concerns, confirmed that the agency is actively reviewing the petition submitted by consumer advocacy groups to halt the use of Red No. 3 in food products. The FDA spokesperson explained that the agency would assess whether there is sufficient data to warrant discontinuing its use.

Regarding the potential cancer risk associated with Red No. 3, identified in 1990, the FDA maintains that this risk pertains specifically to rats and is not relevant to human cancer. Nevertheless, scientists from the Center for Science in the Public Interest dispute this assessment, highlighting the lack of a clear mechanism through which Red No. 3 causes cancer.

Red No. 3 is already subject to stringent restrictions in the European Union and other nations, emphasizing the need for the FDA to revisit its stance on this synthetic dye.

The FDA spokesperson further suggests that state-initiated bans on food ingredients, such as the one enacted in California, could disrupt the national food supply. They underscore the importance of a unified food system and argue that the FDA’s science-based approach is the most effective means to ensure food safety.

While the effects of synthetic food dyes, in general, have been associated with behavioral issues in children, Red No. 3 has drawn particular attention due to evidence of its carcinogenic potential. Dr. Thomas Galligan, a scientist focusing on food additives for the Center for Science in the Public Interest, contends that the FDA should have taken action on this issue years ago. Moreover, his group has been advocating for the ban of eight synthetic food dyes, including Red No. 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3, and a rarely used orange hue since 2008.

Conducting further studies on the effects of synthetic food dyes on humans may be challenging, given the existing body of evidence linking them to behavioral issues. Performing controlled studies in which children are intentionally exposed to dyes may be ethically problematic.

The American Academy of Pediatrics has long advised parents to limit their children’s consumption of sugary drinks, juices, and candy, which are often laced with synthetic dyes. The group has found that these dyes may affect children’s behavior and attention.

Several candy manufacturers have already excluded Red No. 3 from their products, with M&M’s and Skittles serving as notable examples. Nevertheless, the dye remains present in various other products, including specific snacks, cake and cookie icing, decorations, and some Halloween treats.



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