The Food and Drug Administration has announced that it is banning the use of red dye 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 supplements.
Research shows that red dye No. 3 can cause cancer in animals, NBC News reported. Many food safety advocates have been concerned for decades about the presence of this substance in the American food system.
“We are delighted that the FDA has finally taken action to remove this unnecessary color additive from the market and in doing so has followed the clear dictates of the law,” Dr. Peter Lurie, president and CEO of the Center, tells .com. for Science in the Public Interest (CSPI).
“In the absence of pressure from the industry, I think we would all expect this product to have been banned decades ago,” he adds.
Food manufacturers have until January 15, 2027 to remove Red No. 3 from their products, and drug manufacturers have until January 18, 2028 to remove it from ingested medications, according to the FDA.
Why did the FDA ban Red Dye No. 3?
The FDA said it is banning the use of Red No. 3 Dye because of 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 authorize any color additive “if it has been found to induce cancer in humans or animals.”
Jim Jones, the agency’s deputy director of human foods, said there is “evidence” of “cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 dye” in a statement to NBC News.
Red dye No. 3 has not been linked to cancer in people, but Lurie says that’s likely because it’s difficult to study whether substances like food additives cause cancer in humans for a “variety of 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 many people consume it, usually in unknown quantities.
There are also concerns around red dye #3 and children. In 2011, the FDA investigated a possible link between the use of artificial dyes, including Red 3, and hyperactivity in children. But the agency found no causal relationship, NBC News reported.
The national ban comes after California banned the use of red dye #3 in foods in 2023. Ten other states, including Washington, South Dakota, Illinois and Missouri, also introduced laws in recent years to restrict the use of red dye No. 3, according to CSPI.
What is red dye #3?
Red dye #3, also known as erythrosine, is a synthetic food dye that gives foods and beverages a bright red color. It is also sometimes used in oral medications and supplements.
The FDA has approved 36 color additives for use in the United States; nine are synthetic dyes.
On food labels, the substance appears as “FD&C Red No. 3,” “FD&C Red 3,” or “Red 3,” according to the FDA.
In 1990, the FDA banned the use of the dye in cosmetics and topical medications after a study linked the additive to tumors in male laboratory rats exposed to high doses.
Lurie called the banning of Red 3 in cosmetics, but not food, three and a half decades ago a “regulatory paradox,” noting that it was “illegal to use in lipstick, but perfectly legal to administer to children in the form of candy.”
“The main goal of food coloring is to make candies, drinks, and other processed foods more attractive. “When the function is purely aesthetic, why accept any risk of cancer?” he said in a statement.
Many other countries, including Japan, Australia and countries in the European Union, have already banned or restricted the use of red dye #3 in foods, according to NBC News.
What foods contain red dye #3?
While some food manufacturers have already stopped using red dye #3 and other artificial colors in their products, thousands of foods contain red dye #3, according to the CSPI.
“A search of the US Department of Agriculture’s branded foods database on FoodData Central identified 9,201 US food products containing red 3, including hundreds of products manufactured by the nation’s largest food companies,” the CSPI notes. .
Below is a list of some common foods that may contain red 3, according to Lurie, the FDA, CSPI, and Amanda Beaver, a dietitian at Houston Methodist Hospital.
- Sweets, especially seasonal sweets such as candy corn and dyed marshmallows
- Cakes and cupcakes
- Frozen desserts, such as popsicles and strawberry-flavored ice cream
- Glazes
- Maraschino cherries
- Fruit cocktails
- Colored drinks
- protein shakes
- Vegetarian meats
- bacon pieces
- Sausages
- strawberry milk
- Puddings
However, it is important to note that not all items that fall into one of the above categories contain Red 3. That is why Lurie urges consumers to read food labels before making a purchase.
Red 3 must legally be on food labels if present and will be indicated as:
- FD&C Red #3
- FD&C Red 3
- Red 3
Medications with Red No. 3
Lurie says the dye is also present in some oral medications and supplements. According to Drugs.com, some of the oral medications that may contain Red 3 include:
- Acetaminophen, a pain reliever
- Fluoxetine, an antidepressant
- Gabapentin, an anticonvulsant
- Andomeprazole, which treats heartburn
“Virtually everyone consumes Red 3 at some point,” Lurie says. “They really don’t know and they don’t know in what quantities they consume it.”
If you want to read the note in its original version in English, see .
