Beyond Red Dye 3: The Movement to Overhaul U.S. Food Chemical Safety

By Lauren Limbach, HLS class of ’25, Harvard Law School Food Law and Policy Clinic Student

In recent months, the safety of ingredients in the U.S. food supply has been a hot topic of conversation. In both the public health community and amongst the general public, there has been frequent discussion about the large number of chemicals in the American food system and the harms that they may cause. The increased interest in food chemical safety is in part due to the influence of Health and Human Services Secretary, Robert F. Kennedy Jr. (RFK), who has made food ingredient reform an integral part of his Make America Healthy Again platform.

Yet, advocacy to improve the health of ingredients in the food system gained initial momentum even prior to RFK’s nomination. In 2023 and 2024, California passed legislation that restricted the use of six color dyes in schools and banned four ingredients from the food supply with demonstrated potential for harm. And at the tail end of the Biden Administration, the FDA prohibited the use of Red Dye 3 in food after decades of organizations advocating for its removal based on studies that showed evidence of its potential carcinogenicity.

In the second half of 2024, prior to the election, FDA took steps to improve the safety of chemicals in food when the agency published a proposed framework for reassessing the safety of ingredients already on the market. Along with the discussion paper, FDA hosted a meeting and open comment period for industry members, advocacy organizations, and the public to discuss the issue of food chemical safety assessments. Through the meeting and public comment period, it became clear that stakeholders had larger concerns about the current state of food chemical safety in the U.S. FLPC recently published a memo detailing the major trends observed in these comments. The overarching message from across the spectrum of stakeholders is that the FDA’s current systems for managing food chemical safety are broken and that the agency should initiate a complete overhaul of its approach to managing the ingredients that enter the diet of American consumers.

Beyond the overarching calls for reform, there were several themes that repeatedly appeared in stakeholder comments, suggesting emerging consensus on several key initiatives that FDA should prioritize in the immediate future. First, many stakeholders pinpointed the Generally Recognized as Safe (GRAS) process, through which manufacturers can self-determine that their ingredients are safe without FDA knowledge or approval, as ripe for reform. Given the vast number of ingredients that enter the market through the GRAS pathway, commenters pointed out that until FDA has knowledge of all ingredients that enter the market, it will be impossible for the agency to comprehensively address food chemical safety. Additionally, stakeholders recommended that FDA develop a clear methodology for prioritizing food ingredients for review to ensure that the most concerning chemicals are evaluated by the agency as soon as possible. For example, several commenters suggested that FDA begin by reviewing ingredients that have a demonstrated connection to chronic diseases such as cancer and obesity. (FDA has recently proposed a new tool for prioritizing chemicals for review that appears to respond to some of these comments.) Finally, stakeholders across the board echoed a sentiment that FDA should revitalize their approach to food ingredient safety to align with their overall public health mission of ensuring that Americans have access to food that will permit them to live healthy lives.

In addition to growing support for reform within the agency and among stakeholders, initial efforts are underway at both the state and federal level. There is currently a flurry of state legislative action geared towards improving the safety of ingredients in food, including many bills targeting the use of color dyes in schools as well as general use of the same four chemicals of concern identified in California’s legislation. For example, West Virginia recently passed a landmark bill that banned seven color dyes from school foods. Additionally, RFK has taken several major initiatives during his initial months as HHS Secretary, including directing FDA to evaluate rulemaking options for reforming the GRAS process and announcing an agreement with manufacturers to remove artificial color dyes from their products.

Recent legislative activity related to food chemical safety in the U.S. is notable not only for its volume, but for its bipartisan nature and the variety of types of stakeholders involved. Comment submissions included letters from industry organizations, advocacy groups, and members of the general public, and this topic has piqued the interest of both Democratic and Republican lawmakers. Accordingly, it seems that significant momentum is building for largescale reform of food ingredient safety, and advocacy organizations have a unique opportunity to support changes that could form the foundation of a revitalized food ingredient safety system.