Red no. 3 Banned in US Foods, Drugs – Here’s What You Need to Know About the Dye

On January 16, 2025By Littum

Upper line

The Food and Drug Administration has announced it will ban the use of artificial food coloring red no. 3, which has been linked to thyroid cancer in animals, after years of prodding by parents and health advocates, bans in one state and action by dozens of other countries.

Three buckets of Dubble Bubble gum.

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Key facts

The FDA announced Wednesday that it will ban the use of red dye no. 3 in food and ingested drugs, decades after it was banned in cosmetics and externally applied drugs for it connection to thyroid cancer in animals.

Manufacturers using red no. 3 in food or medicine, have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products, and the ban applies to all internationally manufactured products imported into the United States

Red no. 3 or erythrosine, a color additive made from petroleum, could previously be used in foods in small amounts as approved by the FDA on a case-by-case basis.

The FDA has been considering a petition to ban the additive since 2022, at which time California became the first state to outlaw the sale of food with red no. 3, while the legislators in 10 other states introduced legislation to do the same.

Even in its announcement of the ban, the FDA reiterated its position that the additive does not necessarily endanger humans, explaining how the dye causing cancer in rats “does not occur in humans” and noting that exposure levels to the dye are typically much lower in humans than in the investigated rodents.

Robert F. Kennedy Jr., President-elect Donald Trump’s pick for health secretary, has also pledged to strike down about the use of food dyes, if he is confirmed, and claims that the dyes cause cancer and ADHD in children.

Red no. 3 is significantly more regulated in other parts of the world, including i The European Unionwhere it is only permitted for use in cocktails and candied cherries, and i Koreawhere the use of most synthetic colors is prohibited in certain foods that are mostly eaten by children and teenagers.

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What foods have Red Dye 3?

Candy, fruit juice and other snacks are the most common sources of the dye, which is still found in more than 2,800 items on American shelves. Products that have listed red 3 in recent years include some types of Fruit by the Foot, Dubble Bubble gum, Entenmann’s Little Bites, Hostess’ Ding Dongs, Nestle strawberry milk, Jordan almonds, Pez hard candy, Brach’s candy corn, and some flavors of Ringpop , according to the Environmental working group and that Center for Science in the Public Interest (one of the petitioners wants to ban the dye). Grocery chains Albertson’s, Kroger, Meijer’s, Target and Walmart all use Red 3 in some of their house brand products and other items like Betty Crocker’s Stuffed Mashed Potatoes, Vigo Saffron Rice and Don Pancho Green and Blue Tortilla Chips also list the dye as an ingredient.

Which medicine has red dye 3?

Some common medicine which contains red no. 3 includes Tylenol PM, gabapentin, and doxycycline. Red no. 3 is also one inactive ingredient in the capsule shell of the popular ADHD drug Vyvanse.

What are the problems with red no. 3?

Decades-old studies showed that red no. 3 causes cancer in experimental animals, especially thyroid cancer in rats, but the FDA has said these studies “have limited relevance to humans” because cancer is not caused in the same way in both species. There are no studies that show that red no. 3 causes thyroid cancer in humans. Other research has linked the additive to behavioral health problems, such as attention deficit hyperactivity disorder, especially in children. Clinical attempt over the past two decades have shown that children who consumed juices containing food dyes experienced a small but significant increase in hyperactivity, but the connection was not considered strong enough for the FDA to require warning labels about their potential effects on children. In 2021, California state scientists and researchers from the University of California reviewed dozens of experiments and came to a similar conclusionthat food dyes can disrupt normal behavior in some children.

Crucial quote

“There is reasonable suspicion that food dyes may be harmful, at least to some children,” Joel Nigg, a professor of psychiatry at Oregon Health and Science University, told The New York Times. “So why subject them to it?”

big number

215,780. So many pounds of red no. 3 was used in 2021 by the food and pharmaceutical industry, according to the FDA.

Surprising facts

On a body weight basis, children aged 2 to 5 years consume about twice as much of the red dye through food as the general population, according to the FDA.

Key background

The Food and Drug Administration banned red dye no. 3 for use in cosmetics and externally applied drugs in 1990 due to results from unpublished animal research that connected the chemical for thyroid cancer, but it is still approved for use in foods, ingestible drugs and dietary supplements. Any use of the dye must be approved by the FDA, down to the specific batch that is added to food. Companies may only use the additive from batches of the product of which the agency has analyzed a sample and found that it meets the requirements for safety and purity. Red no. 3 must also be declared in the ingredient lists on all food labels that contain the additive. By 2022, a host of health groups, including the Center for Environmental Health, the Environmental Defense Fund, the Public Health Institute, and Healthy Babies Bright Futures filed a petition with the FDA asking it to revoke the right to use red. No. 3 in all foods and ingested substances, calls the additive “unsafe.”