US FDA Announces Phase-Out of Controversial Red No. 3 Food Dye

Jan 15, 2025 at 7:05 PM

In a significant move impacting the food industry, the U.S. Food and Drug Administration (FDA) has decided to phase out Red No. 3 dye from food and ingested drugs due to potential health risks identified in animal studies. This decision follows a thorough review of a petition that cited concerns under the Delaney Clause. The dye, commonly found in various candies, desserts, and medications, will be removed by manufacturers within the next few years. Consumers may still encounter products containing Red No. 3 until the deadline for reformulation arrives, as outlined by the FDA.

Detailed Overview of the FDA's Decision on Red No. 3

In an era marked by increasing scrutiny over food safety, the FDA has taken a decisive step by issuing an order to revoke the authorization for Red No. 3, also known as Erythrosine. This synthetic dye, which imparts a vibrant cherry-red hue to numerous food items and medications, has been under scrutiny for decades. Recent evidence linking it to cancer in laboratory animals has prompted the FDA to act swiftly.

The timeline for this change is set with manufacturers having until January 15, 2027, for foods and January 18, 2028, for ingested drugs to remove the dye from their formulations. Until these deadlines, consumers might still find Red No. 3 listed on product labels if the items were produced before the effective date. This transition period aims to give companies adequate time to reformulate their products without causing market disruption.

Red No. 3 has already faced bans in other regions. For over three decades, it has been prohibited in cosmetics and topical drugs in the United States due to its association with carcinogenic effects observed in animal studies. Internationally, the European Union has long banned the substance, reflecting a broader global concern about its safety.

Consumer Reports has highlighted additional risks, noting that Red No. 3 has been linked to thyroid tumors and neurobehavioral issues like hyperactivity in children. Products affected by this decision span a wide range, including popular candies, breakfast cereals, beverages, and even some medications. Major brands such as PediaSure have already begun removing the ingredient from their offerings, signaling a proactive approach by some companies to address consumer health concerns.

Implications and Reflections

From a journalist's perspective, the FDA's decision underscores the importance of continuous evaluation of food additives to ensure public health. It serves as a reminder that substances once deemed safe can later be found to pose risks. This action calls for increased transparency and vigilance from both regulatory bodies and manufacturers. For consumers, it highlights the need to stay informed about ingredients in everyday products and supports the push for healthier alternatives. Ultimately, this move reflects a growing commitment to prioritizing consumer well-being in the face of evolving scientific understanding.