Jan. 15, 2024 – A long controversial red food dye called FD&C Red No. 3 will finally be banned by the FDA.
The coloring, which is used in thousands of products, is often written on product labels as Red No. 3 or sometimes just Red 3. It is a synthetic compound called erythrosine.
The ban is in response to a petition, the agency stated in a news release, and is within the agency’s regulatory scope because a 1960 law allows the FDA to prohibit color additives if they are found to induce cancer in animals or humans. The petition, submitted in 2022, points to two studies that linked the red dye to cancer in rats.
Despite the forthcoming ban, the FDA maintains that Red 3 has not been scientifically proven to put people at risk.
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the FDA news release stated. “Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”
The ban will go into effect in 2027 for food products and in 2028 for ingested drug products. The delay in implementing the ban is to give manufacturers time “to reformulate their products,” according to the news release. Imported foods will also need to comply with the requirements.
Red 3 is already banned in California, and in 1990 the FDA banned it in cosmetic and topical products.
