The U.S. Food and Drug Administration (FDA) has called on food manufacturers to accelerate the removal of FD&C Red No. 3, a synthetic cherry-red dye, from foods and dietary supplements ahead of the official January 15, 2027 deadline.

This move follows a January 2025 order revoking the dye’s authorization due to cancer risks observed in male lab rats, as cited in a 2022 petition. Although the cancer-causing mechanism is rat-specific and not observed in humans, the FDA acted under the Delaney Clause, which prohibits additives found to induce cancer in animals .

The FDA’s push aligns with broader efforts by the Department of Health and Human Services (HHS) to eliminate petroleum-based synthetic dyes from the U.S. food supply. About 40% of the food industry has already committed to a voluntary phase-out.

To support manufacturers, the FDA is expanding its approval of natural alternatives. Most recently, it approved Gardenia (Genipin) Blue, a plant-derived colorant, for use in beverages and candies. This marks the fourth natural color additive approved in the past two months
The FDA emphasized that any substitute color additive must meet safety standards ensuring “reasonable certainty of no harm” under intended use conditions.

Source
https://www.fda.gov/food/food-ingredients-packaging/fda-encourages-food-manufac…
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FD&C Red No.3 , Color additive , Food Reformulation , FDA Compliance deadline .