FDA Bans Red Dye No. 3 – 11 Products That Contain the Prohibited Ingredient

The federal food regulatory agency has banned a synthetic coloring agent widely used in popular food products, requiring manufacturers to reformulate.

The U.S. Food and Drug Administration (FDA) has banned the usage of FD&C Red No. 3 in food and ingested drugs, citing the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The clause prohibits the approval of additives that could cause cancer in humans or animals.

The decision reportedly follows a 2022 petition that cited studies showing cancer in male rats exposed to high doses of Red Dye 3. Although the mechanism causing cancer in rats does not occur in humans, and human exposure levels are significantly lower, the FDA is required to act when carcinogenic effects are demonstrated in animal studies.

In a statement, the FDA clarified, "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."

This is the latest in a series of actions under the Delaney Clause, including the 2018 ban on certain synthetic flavors.

The Red Dye No. 3 is reportedly a synthetic food dye that adds a bright, cherry-red color to certain products. It is primarily found in candies, cakes, cookies, frozen desserts, frostings, and some ingested drugs.

According to the FDA, it is not as widely used in food and drugs as other certified color additives. The agency's conclusion is based on data from third-party food product labeling databases, manufacturer websites, public information, and FDA certification records.

The following products reportedly contain Red Dye 3, with some also using other synthetic colorants like Red Dye 40.

1. McCormick Red Food Coloring

This product is widely used for decorating desserts, holiday treats, and crafts. Its ingredients include Red Dye 3 and Red Dye 40 for its coloring properties.

2. Good Humor Strawberry Shortcake Dessert Bar

This is a popular frozen treat coated in a layer of strawberry-flavored cake crumbs. The coating on this product uses Red Dye 3 to achieve its color.

3. Yoo-Hoo Strawberry Drink

Yoo-hoo Strawberry Drink is a sweet, pink beverage often enjoyed as a refreshing snack. It contains both Red Dye 3 and Red Dye 40.

4. Trolli Sour Crunchy Crawlers Candy

These multi-flavored gummy worms are coated in a sugary blend that balances sweet and sour. They contain Red Dye 3 among their ingredients.

5. Dubble Bubble Original Twist Bubble Gum

A classic chewing gum, Dubble Bubble Original Twist Bubble Gum uses Red Dye 3 to produce its distinctive pink shade.

6. Brach's Candy Corn

Brach's Candy Corn is a popular seasonal treat known for its tri-colored design, signature texture, and honey-forward flavor. This product contains Red Dye 3 for coloring.

7. Brach's Tiny Conversation Hearts

This product is known for its colorful designs and phrases like "Love You" and "XOXO." It comes in popular flavors like lemon-lime, banana, cherry, grape, orange, and wintergreen. It contains Red Dye 3 and other synthetic dyes.

8. Betty Crocker Red Decorating Icing

Betty Crocker Red Decorating Icing, commonly used for cake decorations and borders, contains Red Dye 3 for its bright red color.

9. Trumoo Strawberry Milk

This flavored milk features Red Dye 3 along with Red Dye 40.

10. Ensure Strawberry Shake

The nutritional supplement, marketed as being from the "#1 doctor-recommended brand," contains Red Dye 3.

11. Kroger's Canned Fruit Cocktail

The artificially colored cherry halves in this product are made with Red Dye 3.

The FDA has urged manufacturers using Red Dye 3 in food products to reformulate by January 15, 2027, and those using it in ingested drugs have until January 18, 2028, to comply with the ban.

While some countries still permit the use of Red Dye 3, also known as erythrosine, in certain products, items imported into the U.S. must meet FDA regulations.

The ban marks the culmination of years of advocacy by public health groups, including the Center for Science in the Public Interest (CSPI), the Environmental Working Group (EWG), and others who petitioned the FDA to take action on Red Dye 3 in 2022.

According to EWG, a 2021 study by California's Office of Environmental Health Hazard Assessment found that synthetic dyes, including Red 3, may contribute to behavioral difficulties in children, such as decreased attention span and memory problems.

Public health advocates praised the FDA's decision as a victory for consumer safety. "This ban sends a strong message that protecting the health of Americans – especially vulnerable children – must always take priority over the narrow interests of the food industry," said Ken Cook, president and co-founder of the EWG.

EWG Senior Scientist Tasha Stoiber emphasized the risks of toxic chemical additives like Red Dye 3, commonly found in candy and other sweets.

She highlighted that widespread exposure to synthetic dyes has raised concerns about long-term behavioral issues, such as ADHD, as there is a need to protect young children from harmful chemicals during critical stages of development.

At the state level, California has also taken action to address harmful additives in schools. The California School Food Safety Act (AB-2316), set to take effect on December 31, 2027, prohibits public schools from offering or selling foods and beverages containing synthetic dyes, including Red 40 and Yellow 5, during school hours.

The act applies to competitive foods sold on campuses, with exceptions for items sold during off-campus fundraisers or outside school hours.

The act reportedly emphasized its focus on student health, specifically banning the sale of food and beverages containing these substances during the school day while promoting compliance with strict nutritional standards.

Schools should provide only competitive foods that meet specific guidelines, including items made from fruits, vegetables, dairy, protein, whole grains, and beverages without added sweeteners. The act was approved by the Governor on September 28, 2024, and filed with the Secretary of State on the same day.