United States regulators have officially banned Red Dye No. 3 from the nation’s food supply, a move that comes nearly 35 years after it was prohibited in cosmetics due to its potential link to cancer.
The dye, known for its bright cherry-red color, is found in numerous consumer items, including candies, snack cakes, maraschino cherries, and some strawberry-flavored beverages.
Food manufacturers will have until January 2027 to reformulate their products to comply with the new Food and Drug Administration (FDA) regulation, while producers of ingested drugs, such as certain cough syrups, have until January 2028 to remove the additive.
What Is Red Dye 3?
Red Dye No. 3, also known as FD&C Red No. 3 or erythrosine, is a synthetic food coloring derived from petroleum. It has been used in the United States since its approval in 1907 to give foods and drinks a vivid red hue. Common applications include candies, frostings, frozen desserts and snack cakes.
The FDA first flagged issues with Red 3 in the 1980s after animal studies linked the additive to cancer in lab rats. While no conclusive evidence connects the dye to cancer in humans, its potential risks have led to bans or severe restrictions in several countries, including the European Union, Australia and Japan.
Other food dyes have been banned in states across the US.
AP
Why Did The FDA Ban Red Dye 3?
Under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, the FDA must prohibit any food additive shown to cause cancer in humans or animals. Animal studies conducted in the 1980s revealed a link between high doses of Red 3 and the development of tumors in male rats, leading the FDA to ban its use in cosmetics in 1990.
However, Red 3 remained in the food supply for decades, prompting criticism from health advocates. A 2022 petition from the Center for Science in the Public Interest (CSPI) and other organizations renewed calls for its prohibition.
FDA Deputy Commissioner Jim Jones confirmed that the ban was a “matter of law,” emphasizing the agency’s duty to act on evidence, even if the cancer risk does not translate directly to humans.
“Today’s action by the FDA marks a monumental victory for consumer health and safety,” Ken Cook, president of the Environmental Working Group, among the groups that had petitioned for the ban, said in a press release.
What Products Contain Red Dye 3?
Red Dye No. 3 is a common ingredient in various foods, drinks and medicines. Items that often contain the dye include:
Candies
- Pez Candy Assorted Fruit
- Dubble Bubble Original Twist Bubble Gum
- Brach’s Candy Corn
- Jelly Belly candies
- Trolli Sour Crunchy Crawlers
Baked Goods and Snacks
- Entenmann’s Little Bites Party Cake Mini Muffins
- Betty Crocker Fruit by the Foot
- Toaster pastries
- Cookies with red icing or decorations
Dairy and Frozen Desserts
- Strawberry-flavored milk
- Certain ice cream flavors and frozen yogurt
- Ice pops and frozen fruit bars
Fruit Products
- Maraschino cherries
- Some fruit cocktails
Beverages
- Yoo-hoo Strawberry Drink
- Certain sodas and fruit-flavored drinks
Medications and Supplements
- Some cough syrups
- Gummy vitamins
- PediaSure Grow & Gain Kids’ Ready-to-Drink Strawberry Shake
Many manufacturers have already started phasing out Red Dye No. 3. For example, Abbott, the maker of PediaSure, has removed the dye from its products, and Dole eliminated it from fruit bowls in 2023.
What Is The FDA’s Deadline For Manufacturers To Reformulate Their Products?
Food manufacturers must remove Red No. 3 from their products by January 2027 to comply with the FDA’s ruling.
Producers of ingested drugs will have an additional year, until January 2028, to reformulate their products. The phased timeline aims to give manufacturers adequate time to identify and transition to alternative coloring agents.
Some companies have already replaced synthetic dyes like Red 3 with natural alternatives, including beet juice, red cabbage pigments, and carmine, a coloring made from insects. However, industry groups such as the National Confectioners Association have expressed concerns about reformulation’s potential challenges and costs.
It’s unclear whether the ban will face legal challenges from food manufacturers because evidence hasn’t determined that the dye causes cancer when consumed by humans.
