By Staff Writer | Editorial credit: paulaah293 / shutterstock.com 

Washington, D.C. — January 15, 2025: In a significant move aimed at improving public health, the Food and Drug Administration (FDA) has officially banned the use of Red No. 3, an artificial colorant commonly used to give food and beverages a bright, cherry-red hue. The ban, announced on Wednesday, is the result of an updated ruling on color additive regulations, which removes the controversial dye from food and ingested drugs.

The decision follows a color additive petition filed in 2022 by health advocates who raised concerns that Red No. 3 could be linked to cancer and behavioral issues in children. In response to these claims and ongoing research, the FDA has determined that Red No. 3 no longer meets the agency’s safety standards for use in consumables.

The new regulations will give manufacturers a transition period to comply with the ban. Companies producing food and beverages that contain the dye will have until January 15, 2027, to reformulate their products. For pharmaceutical manufacturers using the colorant in medications, the deadline is set for January 18, 2028. Additionally, food imports into the United States will be subject to the new ban, ensuring that foreign products comply with the updated regulations.

Red No. 3 has been a widely used synthetic dye since it was first approved by the FDA in the 1970s, primarily in candies, cakes, and processed foods, as well as in certain over-the-counter drugs. However, concerns about its potential health risks have persisted for decades. Animal studies have shown links to thyroid cancer, and some research has suggested that the dye may also contribute to hyperactivity and behavioral problems in children, particularly those with ADHD.

In October 2024, California Governor Gavin Newsom signed into law a groundbreaking bill that bans the use of Red Dye No. 3, along with three other potentially harmful chemicals — potassium bromate, brominated vegetable oil, and propylparaben — commonly found in processed foods. This marked the first time a state has prohibited food additives that are still permitted by the FDA, setting a new precedent for consumer safety.

Despite being banned for use in cosmetics and toiletries in the 1990s due to safety concerns, Red No. 3 has continued to be used in food and drugs, prompting further scrutiny from consumer safety groups. The petition that led to this decision was part of a larger movement calling for more stringent regulations on food additives and dyes.

FDA Administrator Dr. Robert Califf emphasized the agency’s commitment to protecting public health and ensuring that products on the market are safe for consumption. “This ban is part of our ongoing effort to keep potentially harmful substances out of the foods and medications people rely on,” he said in a statement. “We will continue to monitor and update our policies to reflect the latest scientific research.”

The move has been applauded by health advocates, who argue that eliminating Red No. 3 will help reduce the risk of cancer and other health issues linked to artificial food dyes. However, some manufacturers and industry groups have expressed concern about the potential impact on production costs and the challenges of reformulating existing products.

As the deadline for reformulation approaches, manufacturers will face pressure to find alternative colorants that meet both safety and aesthetic standards, while balancing consumer demand for vibrant, visually appealing products.

In the meantime, the FDA has assured the public that it will continue to monitor the safety of color additives and other ingredients used in food and pharmaceuticals, with an emphasis on ensuring consumer protection.

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