The vibrant reds of many popular candies, baked goods, and even some medications are set to change following the U.S. Food and Drug Administration’s (FDA) recent ban on Red No. 3, a synthetic dye also known as erythrosine.
This decision, announced in January 2025, comes after years of scientific scrutiny linking the dye to cancer in laboratory animals. Notably, a 1990 study found that high doses of Red No. 3 led to thyroid tumors in rats, prompting the FDA to prohibit its use in cosmetics and topical drugs at that time.
However, the dye remained prevalent in food products and ingested medications, a point of contention among health advocates. The recent ban aligns the United States with countries like Japan and members of the European Union, which have already restricted or eliminated the use of erythrosine in consumables.
Manufacturers are now tasked with reformulating their products to exclude Red No. 3 by January 2027, with an additional year granted to producers of ingested drugs. This phase-out period is designed to allow companies sufficient time to identify and implement alternative coloring agents that meet safety standards.
The FDA’s action reflects a broader trend toward reassessing the safety of artificial additives in the food and pharmaceutical industries. As consumers become more health-conscious and demand transparency in product ingredients, the move away from synthetic dyes like Red No. 3 may pave the way for increased use of natural colorants.
While this transition presents challenges for manufacturers, it also offers an opportunity to innovate and cater to a market that values safety and natural ingredients. As the implementation deadline approaches, stakeholders will be closely watching how the industry adapts to these regulatory changes and what impact they will have on product formulation and consumer perception.
