The FDA bans red dye #3 in foods

The U.S. Food and Drug Administration (FDA) will no longer allow the use of red dye No. 3 in foods, beverages or ingested medications such as cough syrup, the agency said announced on Wednesday (January 15).

In its announcement, the FDA cited the Delaney clause – part of the Federal Law on Food, Drugs and Cosmetics – as justification for his decision. This clause requires the FDA to ban food and color additives that have been shown to cause cancer in humans or animals.

In this case, “or” is the operative word in this clause. In several studies, red dye No. 3 has been linked to cancer in male laboratory rats, but these carcinogenic effects have not been observed in other animals or humans, the FDA noted.

Nevertheless, these rat studies forced the FDA to ban the additive from cosmetics and topical medications as early as 1990. The Washington Post reported at the time. This decision followed a petition asking the FDA to investigate these specific uses of the dye. Ultimately, the agency also invoked the Delaney Clause when it removed the additive from cosmetics and topical medications, and is now applying the same logic to foods and ingested medications.

Related: What is brominated vegetable oil and why has the FDA banned it in food?

In one of the rat studies, 70 male rats were fed very high doses of red dye #3, equivalent to 4% of their lifetime diet. Fifteen of the rats developed tumors of the thyroid, a gland in the neck, but most of the tumors were noncancerous. No tumors appeared in male rats given lower doses of the dye and in female rats given any dose. And when scientists conducted the experiment on mice instead of rats, they saw no tumors in either men or women.

Later studies suggested that the tumors were due to a specific hormonal change triggered by the accumulation of red dye in male rats. However, this hormonal mechanism is only relevant to rats, the Post reported.

In short: “The way FD&C Red No. 3 causes cancer in male rats, does not occur in humans,” the FDA emphasized in its announcement. Furthermore, “the relevant exposure levels to FD&C Red #3 for humans are typically much lower than those producing the effects shown in male rats.” The available evidence therefore suggests that Red #3 ingestion poses no risk for represents people.

However, “it doesn’t matter because FDA’s mandate under the Delaney Clause is to keep animal or human cancers out of the food supply.” Jennifer PomeranzAssociate Professor of Public Health Policy and Management at the School of Global Public Health at New York University, said CNN.

Therefore, the FDA banned the dye “for legal reasons,” it said in its statement.

Red dye #3, also called erythrosine, gives products a bright, cherry red color. The FDA noted that the dye is found in some candies, cakes, cookies and frozen desserts, among other things, but is not as common as other food dyes.

Certain brands of fruit cocktails, lollipop rings, beef sticks and sweet corn are among the foods that contain the dye, according to a Database compiled by the Environmental Working Group (EWG), a non-profit consumer protection organization.

EWG, which has a sister organization called EWG Action Fund, has been a vocal supporter of banning red dye No. 3. In 2022, it and other organizations will applied to the FDA to re-evaluate the additive and to ask the Agency to take into account in particular the Delaney clause. (The EEC has historically some drawn criticism for exaggerating the dangers of various chemicals in food and the environment.)

All U.S. food manufacturers that use red dye No. 3 have until January 2027 to reformulate their products, while drugmakers have until January 2028. Products imported into the country must also comply with the ban.

This article is for informational purposes only and does not constitute medical advice.

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The FDA bans red dye #3 in foods

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