The U.S. Food and Drug Administration (FDA) has announced a ban on the use of FD&C Red No. 3, a synthetic compound known as erythrosine, in food and drug products. This decision stems from a petition submitted in 2022, supported by studies linking the dye to cancer in rats. The ban will take effect in 2027 for food products and in 2028 for ingested drug products. The FDA's regulatory authority allows it to prohibit color additives found to induce cancer in animals or humans, as per a law enacted in 1960. Despite the ban, the FDA asserts that there is no scientific evidence proving that FD&C Red No. 3 poses a risk to human health.
FD&C Red No. 3, often labeled simply as Red No. 3, is widely used in thousands of food items and other consumables. Its previous use in cosmetics and topical products was prohibited by the FDA in 1990. Moreover, California has already enforced a ban on this coloring. The recent FDA decision is a response to ongoing concerns about its safety, following two specific studies that identified carcinogenic effects in male rats.
In a news release, the FDA clarified that the effects observed in animal studies do not directly translate to humans.
“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,” – FDA news release
This statement emphasizes the difference in exposure levels and biological responses between species, suggesting that human health risks are minimal according to current scientific data.
The FDA remains firm that available information does not support claims of cancer risk from FD&C Red No. 3 in food and ingested drugs. However, the agency continues to act within its legislative powers to ensure consumer safety by addressing potential hazards indicated by animal studies.
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