The U.S. Food and Drug Administration (FDA) has banned the use of FD&C Red No. 3 in foods, beverages, and ingested medications. This substance has been linked to cancer in animals for more than three decades.
The decision responds to a request submitted in November 2022 by several nonprofit organizations and individuals. The agency has determined that the data presented reveal that the compound causes cancer in male laboratory rats exposed to high levels of the ingredient. He clarifies that “studies in other species did not show the same effect and There is no evidence to show that the dye causes cancer in humans.”.
Food and beverage companies that use red dye number 3 have until January 15, 2027 to reformulate their products. The deadline is extended until January 18, 2028 for pharmaceutical manufacturers. Goods imported into the United States must also comply with these regulations.
What is red dye number 3?
FD&C Red No. 3, also known as erythrosine, is a petroleum-derived food pigment. The FDA indicates that it is added to ultra-processed foods such as candy, cakes, cookies, frozen desserts, frostings, beverages and certain orally administered drugs to give them “a bright cherry red hue.” The Environmental Working Group estimates that the additive is present in nearly 3,000 food products sold in the United States.
General use of the dye was approved in 1969. Its use in cosmetics and topical medications was restricted in 1990 due to its association with cases of cancer in rodents. The FDA maintained its authorization of the food coloring after finding no conclusive evidence demonstrating a risk to humans.
The agency has periodically evaluated the safety of D&C Red No. 3. Its findings indicate that “the exposure levels relevant to the dye for humans are typically much lower than those that cause adverse effects in rats. Claims that use of the compound in foods and ingested medications puts people at risk are not supported by available scientific information”.
Despite this, a study prepared by the California Office of Environmental Health Hazard Assessment concluded in 2021 that the dye increases children’s vulnerability to behavioral disorders. He warned that the intake levels considered safe by federal authorities could be insufficient to protect the neurological health of minors.
The possible harmful health effects of FD&C Red No. 3 have been considered by various international and national health organizations. The European Union banned the use of the ingredient in foods in 1994. The government of California, United States, made a similar decision in October 2023. The Center for Science in the Public Interest indicates that at least 10 other US entities have introduced legislation to restrict the additive.
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