Dubble Bubble Bubble Gum uses Red Dye No. 3, which has been banned by the U.S. Food and Drug Administration (FDA) but is still allowed in Canada.ROBERTO SCHMIDT/AFP/Getty Images
U.S. regulators announced Wednesday that a dye known as Red No. 3 will be banned from the American food supply, nearly 35 years after it was barred from cosmetics because of a potential link to cancer.
In Canada, however, the dye is still permitted in food products within certain limits.
The Food and Drug Administration describes FD&C Red No. 3 as a synthetic food dye used to give foods and beverages a cherry-red colour.
The U.S. agency tasked with protecting public health said the dye has primarily been used in certain foods such as candy, cupcakes and cakes, frozen desserts, frostings and icings along with some medications.
Why did the FDA ban Red No. 3?
While the FDA said current evidence does not support a link between the dye and cancer in humans, the agency explained its decision as “a matter of law.”
The Delaney Clause, enacted into U.S. law in 1960, prohibits FDA authorization of a food additive or colour additive if it has been found to induce cancer in animals or humans.
The FDA said it received a petition in 2022 that requested it review whether the clause applied to the dye. It cited two studies that showed cancer in male laboratory rats that were exposed to high levels of the dye.
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” the agency said.
“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. 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 FDA said manufacturers who use the dye in food and ingested drugs have until Jan. 15, 2027, or Jan. 18, 2028, respectively, to reformulate their products.
It noted that some other countries still permit use of the dye, but foods imported into the U.S. will have to comply with FDA requirements.
The International Association of Color Manufacturers noted in a statement Wednesday that the decision was made despite the FDA’s own acknowledgment that the additive does not pose a risk to human health based on available scientific evidence.
In 1990, the FDA stopped authorizing the use of Red No. 3 in cosmetics and non-oral medications after a study showed it caused cancer when it was eaten by rats.
Another food additive known as Red 40 is not covered by the FDA’s latest ban.
What does Health Canada say about Red No. 3?
Canada does not have a law in effect that is akin to the Delaney Clause.
André Gagnon, a spokesperson for Health Canada, said in a statement that Red No. 3 has been permitted as a food colour in Canada and internationally for many years, with levels established for maximum use.
Mr. Gagnon said claims that the use of this colour in food puts people’s health at risk are not supported by the available scientific evidence.
He also pointed to how the Joint United Nations Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives re-evaluated the safety of Red No. 3 in 2018.
Health Canada reviewed an evaluation from an expert committee that considered the toxicological studies in experimental animals and concluded that the dye does not pose a health risk to humans at levels specified in Canadian regulations.
What do Canadian consumers need to know?
Waliul Khan, a professor in the department of pathology and molecular medicine at McMaster University, said in an interview that it would be helpful to have more research on the food additive’s effect on human subjects. He noted that the dye has no nutritional value.
The dye has already been restricted in other jurisdictions including the European Union.
Prof. Khan also said he supports the use of labels to increase consumer awareness of potential health effects.