The Food and Drug Administration (FDA) is facing renewed scrutiny over a food dye known as Red 40, with top officials acknowledging the agency hasn’t formally reevaluated its safety in over a decade. This revelation comes amidst growing concerns about the potential health effects of Red 40, particularly regarding behavioral issues in children. While the FDA has initiated a new program to re-examine previously approved food additives, budget limitations and bureaucratic processes mean catching up with international counterparts could take years.
Senator Tommy Tuberville pressed FDA Deputy Commissioner for Human Foods, Jim Jones, about both Red 40 and another dye, Red 3, during a Senate hearing. Red 3 is already under significant pressure due to studies linking it to cancer in animals, and Jones hinted at a potential ban within weeks. The broader debate around synthetic food dyes is gaining traction, fueled by figures like Robert F. Kennedy Jr., who has publicly criticized the use of these additives.
This renewed attention begs the question: what exactly is Red 40, and why is it at the center of so much controversy?
Decoding Red 40: From Chemical Name to Common Uses
FD&C Red No. 40, commonly known as Red 40, is a synthetic color additive approved by the FDA in the 1970s. Within the food industry, it’s often referred to as Allura Red AC, and in Europe, it carries the designation E 129. This dye is now primarily derived from petroleum, a fact that might surprise many consumers.
To create variations like “Red 40 Lake,” Red 40 is combined with aluminum. These “lakes” are particularly useful in products with low moisture content, such as chewing gum, or in frostings, where they prevent color bleeding. The FDA emphasizes rigorous oversight of Red 40 production, subjecting each batch to purity testing to ensure it is free from contaminants arising from the manufacturing process. Interestingly, Red 40 consistently tops the list in terms of production volume among dyes undergoing this certification.
Alt text: Colorful array of processed foods, highlighting the prevalence of Red 40 in common snacks and drinks.
Lisa Lefferts, an environmental health consultant, points out the difficulty consumers face in avoiding these dyes. “People think that ‘I know which foods have dyes and which don’t,’ but no you do not. White foods can contain dyes, foods marketed as healthy and natural can contain dyes, egg noodles can contain dyes,” she explains. Reading labels becomes essential to identify and avoid Red 40 and other synthetic dyes. Lefferts has been actively involved in advocating for stricter regulations on synthetic food dyes, including supporting California’s recent law banning Red 40 and similar dyes in school meals starting in 2028. She highlights the significant impact dye sensitivities have on families, noting, “If you talk to parents whose kids are sensitive to dyes, they’ll tell you how difficult it is to avoid dyes and what a huge change it was for their entire household to try to get these dyes out of their kids’ diets.”
Red 40 vs. Red 3: Understanding the Distinction
While Red 40 is under scrutiny, it’s important to differentiate it from Red 3. Red No. 3, also petroleum-based, is known for its bright cherry-red hue, commonly found in candies and various food items.
Dr. Céline Gounder, a CBS News medical contributor, explained the concerns surrounding Red 3: “There seems to be an increased risk, at least in rats, of thyroid cancer. We also see an association with hyperactivity in kids.” Due to these concerns, scientists and consumer groups have petitioned the FDA to revoke approval for Red No. 3, with potential action expected soon. Notably, Red No. 3 has already been banned in cosmetics and topical medications since 1990, indicating a pre-existing recognition of its potential risks in certain applications.
Alt text: Vivid red gummy candies, illustrating the intense color imparted by dyes like Red 3 and Red 40, and their common presence in children’s treats.
Where is Red 40 Found? Common Foods and Products
A 2016 FDA study revealed that children’s primary exposure to Red 40 comes from drinks, frozen desserts, and cereals. Databases from the U.S. Department of Agriculture and the Environmental Working Group list thousands of products containing Red 40, extending beyond food to include medications and cosmetics.
Common examples of foods with Red 40 include popular cereals like Kellogg’s Froot Loops and General Mills’ Lucky Charms. Frozen desserts such as various ice cream brands and flavors, and soft drinks like Gatorade Fruit Punch and Fanta Soda, also frequently utilize Red 40. Even seemingly innocuous products like strawberry milk and pink lemonade mixes can contain this dye.
WK Kellogg, the maker of Froot Loops, maintains that their foods are safe and compliant with regulations. However, consumer advocacy groups continue to push for the removal of artificial colors, especially as less brightly colored versions of products like Froot Loops are available in markets like Canada.
Dr. Gounder emphasizes the importance of label reading as the only reliable way to identify synthetic dyes in products. “You can’t look at the color. Even white foods may have synthetic dyes to make it brighter,” she cautions.
The Core Concerns: Why the Calls to Restrict Red 40?
The primary push to limit Red 40 stems from a 2007 study commissioned by British food authorities. This research indicated a link between mixtures of synthetic food dyes, including Red 40, and increased hyperactivity in children.
While Europe and Canada did not implement outright bans, the UK and the European Union mandated warning labels for foods containing these dyes. These labels state that the product “may have an adverse effect on activity and attention in children.”
California’s Environmental Protection Agency, in a 2021 review of numerous studies, corroborated the link, concluding “that synthetic food dyes can cause or exacerbate neuro-behavioral problems in some children,” specifically including Red 40.
Lisa Lefferts argues that eliminating synthetic dyes is a “no-brainer” given these concerns. She praises California’s approach of incorporating animal and lab studies to strengthen the evidence base, filling gaps in human research. “Synthetic food dyes are completely unnecessary. They can be omitted entirely or replaced with safe alternatives. Their purpose is purely cosmetic and we have all this evidence,” she asserts.
Alt text: Young child examining a box of brightly colored cereal, visually representing the target demographic’s potential exposure to and consumption of Red 40 through popular food choices.
Counterarguments from the International Association of Color Manufacturers point to past FDA advisory panels and international health authorities that have not definitively established a causal link between Red 40 and hyperactivity. Sarah Codrea, the trade group’s executive director, states, “The FDA regulates the safety and labeling of all color additives, and it does so based on scientific evidence. As such, the FDA has determined and continues to maintain that FD&C Red No. 40 is safe.”
The Regulatory Landscape in the U.S.: Why No Ban Yet?
Following the European actions after the 2007 British study, the FDA convened its food advisory panel in 2011 to reassess the safety of dyes like Red 40. The panel narrowly voted against recommending warning labels, citing insufficient evidence of a direct causal link. However, some members acknowledged the data raised concerns. Dr. Francisco Xavier Castellanos, a committee member, noted, “Causality is a distant aspiration, but certainly these data don’t give us any confidence that we can say there’s nothing to worry about here.”
In 2019, an FDA science board meeting concluded that while most children are unaffected by color additives, a sensitive subpopulation might exist. An FDA spokesperson reiterated the agency’s commitment to reassessing chemical safety as new data emerges.
However, removing previously approved chemicals from the market is a complex “rulemaking” process. The FDA must navigate legal challenges and address concerns, often from well-funded industries. Dennis Keefe, former director of the FDA’s office of food additive safety, explains, “The agency can’t just wave a wand and say, we don’t like these anymore. There’s whole industries that have been developed using this color additive with the understanding that it’s safe.”
Adding warning labels also requires demonstrating a “compelling public health reason” due to First Amendment considerations regarding compelled speech. Without congressional mandates or extensive new research, the FDA faces significant hurdles in taking further action on Red 40, especially with other pressing public health priorities competing for limited resources. Keefe concludes, “And they would have to have good data that Red 40 in particular is causing these hyperactivities. And the data just really aren’t that tight.”
In Conclusion
Red 40 remains a widely used food dye in the United States, despite ongoing debates and concerns about its potential link to hyperactivity in children. While regulatory bodies in Europe have opted for warning labels, and California is moving to ban it in school meals, the FDA has yet to take similar action. The controversy highlights the complexities of food regulation, the need for ongoing scientific evaluation, and the importance of informed consumer choices. As the debate continues, understanding what Red 40 is and where it’s found empowers individuals to make dietary decisions that align with their health priorities.
