All color additives in the United States must be approved by the Food and Drug Administration (FDA) prior use in food and drugs. In addition, the post-market assessment of color additives in food is a significant priority for the FDA. Currently, 36 color additives are FDA-approved, nine of which are synthetic dyes including both Red Dye 3 and Red Dye 40. The post-market responsibility includes a review of many additives, including the recently controversial Red Dye 3. Although evidence shows Red Dye 3 is not harmful to humans, the FDA may be obligated to ban the colorant in foods and ingestible drugs in part due to a legal technicality. Red Dye 3 is found in many beverages, snacks, cereals and candy, as well as some ingestible drugs.
An FDA review completed over a decade ago concluded that Red Dye 3 is safe. However, the safety of both Red Dye 3 and Red Dye 40 have recently been challenged in many states, most notably by California. Red Dye 3 is banned from sale, distribution and manufacturing in California beginning in 2027. While several other states including Illinois and Washington have proposed similar legislation, there is also a petition seeking to expand the ban on certain colorants nationwide.
The safety assessment of Red Dye 3 is complicated by conflicting animal and human safety data. While Red Dye 3 is generally known to be cancerous to laboratory animals, specifically rats, there is some consensus that this mechanism of carcinogenicity is not applicable to humans. This presents a special concern for the FDA, because the Food, Drug and Cosmetics Act contains a clause, The Delaney Clause, prohibiting the FDA from authorizing for use any chemical that is shown to be carcinogenic in animals or humans at any dose. Besides the issue of carcinogenicity, there are also concerns about the effects of Red Dye 3 on neurobehavior in children.
As part of the Agency’s reorganization, the Human Foods Program has been created in part for centralized and efficient risk management. One role of the Human Foods Program is ongoing post-market reviews of chemicals used in food. While the FDA continues to review all publicly available information about the safety and toxicology of food color additives, there is no formal statutory requirement for the function. Budget concerns exist and regulators are examining a formal approach for post-market evaluations. The FDA is seeking feedback on post-market evaluation processes through January 21, 2025.
It is expected that a decision on the status of Red Dye 3 will be forthcoming shortly. This decision will serve as a response to a petition filed more than two years ago by the Center for Science in the Public Interest (CSPI), the Environmental Working Group, and other public health groups asking that FDA ban the use of Red Dye 3 use in food and drugs. It is likely that any sort of ban action will be further addressed in court. Currently, the FDA lacks conclusive data demonstrating that Red Dye 3 causes cancer in humans, which would likely make any ban difficult to uphold in court.
About the Author
Julie Holt is a subject matter expert in the areas of food and beverage, additives and regulatory strategy. Ms. Holt’s expertise includes the beverage industry, with current consulting support across multiple beverage categories.
Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, she supported several food and beverage clients including a Fortune 50 company. Holt has provided global regulatory knowledge covering more than 200 countries. Her consulting efforts have supported global regulatory needs, R&D projects, sustainability goals and innovation initiatives.
