Why the FDA banned a red dye found in candy, sweets and drugs

The United States is banning red dye number 3, a controversial food additive, following studies linking its use to health risks including thyroid cancer in rodents. This choice raises questions about the safety of colorings in food and their long-term effects.

In the United States, the Food and Drug Administration (FDA) decided toto forbid the red coloring number 3 (red dye No. 3), known aserythrosine (E127), a synthetic additive derived from oilused in many food and pharmaceutical products. L’erithrosine is particularly present in confectionery, ice cubes, ice creams, candied cherriesas well as in certain medicines and cosmetics.

The regulation of this dye varies from country to country. In the United States, it had already been banned since the 1990s in cosmetics and the topical medicationsbut not in food. On the other hand, theEuropean Union banned it since 1994with the exception of certain products such as candied cherries used in desserts. The FDA has reevaluated the safety of this additive several times and, after much debate among scientists, companies and regulators, has made the decision topermanently ban its sale. Food companies have until January 15, 2027 to comply, while the pharmaceutical industry has a year more.

The main reason for the ban comes from two studies showing that high doses of the dye cause thyroid cancer among the male ratseven if the FDA specifies that this biological mechanism is not observed in humans. The withdrawal is linked to a petition asking whether the clause Delaneywhich prohibits the use of additives known to be carcinogenic, applies to this coloring. Despite the lack of evidence of risks to humans, the demonstration of the link to cancer in rodents led to theinterdiction.

This process was long and punctuated by conflicts, due to the regulatory complexity surrounding the Delaney clause. Studies have also linked erythrosine consumption to various health problems such ashypertyroïdieasthma,insomnia and allergies. A 2011 study concluded that erythrosine has “minimal effect” at oral doses of 200 mg per day, while a dose of 60 mg shows no effect. Considering the average usage, estimated at 0,0031 mg/kg of body weight per day, the panel of experts of theESFA was reassured about the safety of the additive. However, theinterdiction of the FDA could prompt a new evaluation in the EU and lead to a complete ban erythrosine, in favor of other dyes without known risks.