The U.S. Food and Drug Administration (FDA) announced a pivotal change in its regulations concerning the color additive known as Red 3 on January 15. This decision stems from a successful 2022 petition by health groups and activists citing concerns over Red 3's link to cancer. While the ban will not take immediate effect, it will significantly impact the food and pharmaceutical industries in the coming years.
Red 3, also referred to as "FD&C Red No. 3," "FD&C Red 3," and "erythrosine," has been a staple in food and medication coloring since its FDA approval in 1969. Used predominantly in candies, cakes, cupcakes, cookies, frozen desserts, frosting, icings, and some drugs, Red 3 is found in over 9,000 brand-name foods according to the U.S. Department of Agriculture's database. As a result of the FDA's ban, these products will need reformulation by January 2027 for food items and by January 2028 for consumable medications.
The decision to amend the color additive regulations comes after studies indicated that high levels of Red 3 were linked to cancer in rats. Although these findings do not translate directly to humans, the FDA maintains strict guidelines prohibiting the authorization of any color additives shown to induce cancer in either humans or animals.
"FD&C Red No. 3," "FD&C Red 3," "Red 3" and "erythrosine" – FDA
Despite the forthcoming ban on Red 3, its counterpart, Red 40, remains unaffected. Red 40 is a widely used synthetic dye in the U.S., imparting a vibrant crimson hue to various condiments and candies. It is the most consumed dye per pound among three major food dyes found in over 36,000 products nationwide.
The FDA's decision has cast a spotlight on the extensive use of Red 3 across numerous consumer items. While the dye will continue to be available until the set deadlines, manufacturers will need to explore alternatives to meet regulatory compliance. This transition period allows time for the industry to adapt and ensure that affected products still meet consumer expectations without compromising safety.
