In a significant move to enhance consumer safety, the U.S. Food and Drug Administration (FDA) has announced a ban on the use of Red Dye No. 3 in food products, dietary supplements, and ingested medications. This decision comes nearly 35 years after the dye was prohibited in cosmetics due to cancer risks identified in laboratory animals.
Red Dye No. 3, or erythrosine, is a synthetic color additive derived from petroleum. It imparts a bright cherry-red hue to various consumables. Commonly found in candies, baked goods, flavored beverages, and certain medications, the dye has been a subject of health debates for decades.
According to AP News, Red Dye No. 3 is currently found in a variety of products, particularly candies like Brach’s Conversation Hearts and Candy Corn, as well as baked goods with red icing, such as Betty Crocker Red Decorating Icing. It is also used in some dairy and frozen foods, including TruMoo Strawberry Whole Milk, and fruit products like Kroger Extra Cherry canned fruit cocktails. Additionally, it appears in beverages such as Ensure Original Strawberry Nutrition Shake and certain medications and gummy vitamins, though many products have transitioned to Red 40 or natural color alternatives.
The FDA’s decision is grounded in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which mandates the prohibition of any food additive shown to induce cancer in humans or animals. Studies have linked high doses of Red Dye No. 3 to thyroid cancer in male rats, prompting concerns about its safety in human consumption. Although there is no conclusive evidence directly linking the dye to cancer in humans, the FDA has opted for a precautionary approach to mitigate potential risks.
Food manufacturers are required to eliminate Red Dye No. 3 from their products by January 2027, while pharmaceutical companies have until January 2028 to comply. This timeline allows industries sufficient time to reformulate products and identify suitable alternative colorings. Many companies have already begun transitioning to natural colorants such as beet juice, carmine, and annatto, which are perceived as safer options.
Consumer advocacy groups have lauded the FDA’s action. In 2022, several organizations petitioned the agency to ban the dye, citing animal studies and potential health risks. According to CNN, their efforts have been instrumental in bringing this issue to the forefront of public health policy. Dr. Jerold Mande, an adjunct professor of nutrition at Harvard University T.H. Chan School of Public Health, expressed support for the FDA’s decision, stating via email, “Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way.”
Internationally, the use of Red Dye No. 3 has been restricted or banned in regions such as the European Union, Australia, and Japan. The FDA’s recent decision aligns the United States with these global standards, reflecting a growing consensus on the need to regulate synthetic food additives more stringently. This decision by the federal agency also follows California’s move to ban the additive, enacted in October 2023.
Despite the ban, some experts argue that the actual risk to human health from Red Dye No. 3 is minimal, given the high exposure levels used in animal studies compared to typical human consumption. Nonetheless, the FDA emphasizes that the ban is a proactive measure to ensure consumer safety, adhering to legal requirements that prohibit carcinogenic substances in food and drugs.
The impact of this ban will be widespread, affecting a variety of products that currently contain the dye. Consumers are advised to check product labels and be aware of the upcoming changes. Manufacturers are expected to reformulate their products to comply with the new regulations, potentially leading to changes in the appearance of some foods and medications.
The FDA’s ban on Red Dye No. 3 represents a significant step toward enhancing food and drug safety in the United States. While the direct risk to human health may be debated, the precautionary removal of a potentially carcinogenic substance underscores the agency’s commitment to public health. As the compliance deadlines approach, consumers and manufacturers alike will need to adapt to the evolving landscape of food and drug safety regulations.