The U.S. Food and Drug Administration (FDA) has announced a ban on the use of Red No. 3 in food and ingested drugs, citing health risks associated with the synthetic dye. This vivid cherry-red colorant, commonly found in various foods and medications, will be phased out starting January 2027. Food manufacturers have until January 15, 2027, to remove Red No. 3 from their products, while drug producers must comply by January 18, 2028.
Red No. 3 is a synthetic dye that imparts a bright red hue to numerous food items, including candies, cakes, cookies, frozen desserts, and frostings. It is also present in certain ingested medications such as gabapentin and specific cough syrups. Despite its widespread use, the FDA's decision follows concerns raised by studies indicating potential cancer risks associated with high exposure levels in male lab rats.
“The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.” – FDA
The FDA's action stems from a color additive petition filed in 2022 by more than a dozen food safety and health advocates. These advocates pushed for the removal of Red No. 3 due to its potential health implications. Their efforts echo the practices already implemented in Europe, Australia, and New Zealand, where the dye has been banned in food and ingested drugs.
Despite the alarming findings in lab rats, the FDA has clarified that human exposure levels to Red No. 3 are typically much lower than those causing effects in the animal studies. Furthermore, research conducted in other animals and humans did not show the same harmful outcomes.
“Prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.” – FDA
The use of Red No. 3 is not as prevalent as other certified colors, but its presence in everyday food items raises significant concerns for consumer health. Ken Cook, president and cofounder of the Environmental Working Group, hailed the FDA's decision as a significant step forward.
"Today’s action by the FDA marks a monumental victory for consumer health and safety." – Ken Cook
Food manufacturers and drug producers now face the task of reformulating their products to comply with the upcoming ban. This move aims to align U.S. regulations with international standards and safeguard public health by reducing potential carcinogenic risks.
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