The Food and Drug Administration has announced the use of Red No. 3, a synthetic dye that has long been used in the United States to color certain foods such as candy and colored drinks, as well as some oral medications and dietary supplements.

Research shows that Red No. 3 can cause cancer in animals, NBC News reported. Many food safety advocates have been concerned about the substance’s presence in the U.S. food system for decades.

“We are pleased that the FDA has finally taken action to remove this unnecessary color additive from the market, following the clear guidance of the law,” said Dr. Peter Lurie, president and CEO of the Center for Science in the USA Public Interest (CSPI), tells TODAY.com.

“If there is no lobbying from the industry, I think we would all expect this product to have been banned decades ago,” he adds.

According to the FDA, food manufacturers have until January 15, 2027 to issue Red No. 3 from their products, and drug manufacturers have until January 18, 2028 to remove it from ingested medications.

Why did the FDA ban red dye #3?

The FDA said it was banning the use of Red Dye No. 3 due to evidence that the synthetic color additive can cause cancer in animals.

The agency says that under a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA cannot approve a color additive “if it has been determined to cause cancer in humans or animals.”

Jim Jones, the agency’s deputy director of human foods, said in a statement to NBC News that there was “evidence” of “cancer in male lab rats exposed to high levels of FD&C Red Dye No. 3 were exposed”.

Red dye No. 3 has not been linked to cancer in humans, but Lurie thinks this is likely because it is difficult to study whether substances such as food additives cause cancer in humans for “various technical reasons.”

For example, it is unethical to give human participants a substance that can cause cancer for a double-blind study, and studying cancer rates in the population that consumes Red 3 is challenging because so many people consume it, usually in unknown amounts.

There are also concerns about Red Dye #3 and children. In 2011, the FDA investigated a possible link between the use of artificial colors, including Red 3, and hyperactivity in children. However, according to NBC News, the agency was unable to determine a causal connection.

The national ban comes after California banned the use of red dye No. 3 in foods in 2023. Ten other states, including Washington, South Dakota, Illinois and Missouri, have also introduced legislation in recent years to restrict the use of red No. 3 dye, according to CSPI.

What is Red Dye #3?Red Dye #3, also called erythrosine, is a synthetic food coloring that gives foods and drinks a bright red color. It is also sometimes used in oral medicines and dietary supplements.

According to the FDA, the substance is listed on food labels as “FD&C Red No. 3”, “FD&C Red 3” or “Red 3”.

In 1990, the FDA banned the dye’s use in cosmetics and topical medications after a study linked the additive to tumors in male lab rats exposed to high doses.

According to NBC News, many other countries, including Japan, Australia and European Union countries, have either already banned or restricted the use of red dye No. 3 in food.

Which foods contain red dye number 3?

According to CSPI, thousands of foods contain red dye No. 3. Lurie says the dye is also found in some oral medications and dietary supplements.

“A search of the U.S. Department of Agriculture’s branded food database at FoodData Central revealed 9,201 U.S. food products containing Red 3 – including hundreds of products from the nation’s largest food companies,” the CSPI notes.

Here’s a list of some common foods that may contain Red 3, according to Lurie, the FDA, the CSPI and Amanda Beaver, a nutritionist at Houston Methodist Hospital.

• Sweets, especially seasonal sweets like candy corn and colored marshmallows
• Cakes and cupcakes
• Frozen desserts like popsicles and strawberry flavored ice cream
• frosting
• Maraschino cherries
• Fruit cocktails
• Colored drinks
• Protein shakes
• Vegetarian meat
• Pieces of bacon
• Sausages
• Strawberry milk
• pudding

However, it is important to note that not every item that falls into any of the above categories contains Red 3. For this reason, Lurie urges consumers to read food labels before making a purchase.

Red 3 is required by law to appear on food labels where available and is listed as follows:

• FD&C Red No. 3
• FD&C Red 3
• Red 3

According to Drugs.com, oral medications that may contain Red 3 include:

• Acetaminophen, a painkiller
• Fluoxetine, an antidepressant
• Gabapentin, an anticonvulsant
• Andomeprazole, which treats heartburn

“Virtually everyone consumes Red 3 from time to time,” says Lurie. “They don’t really know it and don’t know what quantities they’re consuming it in.”