Back in January, the Food and Drug Administration (FDA) announced a nationwide ban on the artificial additive Red No. 3, also known as erythrosine, in all food and medications in the US.
The synthetic dye had already been banned from cosmetics, ingested drugs, and topical medications decades ago due to research linking it to behavioral issues in children, including ADHD. It has also been associated with thyroid cancer in animal studies.
Manufacturers now have until January 15, 2027, to stop using the coloring in food, and until January 18, 2028, for medication. In the meantime, it remains in use—making it all the more important to stay informed.
Click through this gallery to learn more about the potential harms of Red No. 3 and other synthetic dyes you may want to avoid.
In 1950, Halloween candy caused sickness among dozens of children in cities across the United States. While no fatalities occurred, the culprit was a toxic FDA-approved dye used to color candy, known as Orange No. 1.
This Halloween incident marked a wake-up call for food safety regulation. Orange 1 was a color additive that could be found in all types of food at the time, including candy and hot dogs.
Orange 1, a common food dye, was popular for its bright festive hue, but caused severe health issues in consumers, including rashes and diarrhea.
The Halloween incident triggered a regulatory overhaul as the FDA banned Orange 1 and other unsafe additives, including Red No. 3 and Orange No. 2.
Another synthetic dye, known as Red No. 3, has replaced earlier additives, but brought new concerns. Red 3 can be found in candy and almost 3,000 other food products in the United States.
Red No. 3, also known as erythrosine, has also been used as a printing ink, dental plaque disclosing agent, and even as a sensitizer for orthochromatic photographic films.
Red 3 has been been linked to thyroid cancer in rats and also behavioral issues in children. Despite these issues, the additive can still be found in thousands of products today. Why is that?
Synthetic dyes have been part of food manufacturing since 1907, before the FDA even existed. Red No. 3 is one of nine synthetic dyes that have been approved for use in the United States.
Of the nine approved synthetic dyes, Orange B and Citrus Red No. 2 have been approved only for limited use, but the other seven are approved for a multitude of products, including drugs, cosmetics, and food. However, Red 3 is the exception.
After the 1950 Halloween fiasco, new legislation came into effect across the US, which included the 1958 Food Additives Amendment and the 1960 Color Additives Amendment. These laws required the FDA to evaluate all food dyes for safety.
As a result of the new legislation, all color additives used prior to that required revision and formal approval once again. Several additives were permanently approved in the following years, but loopholes still existed.
In 1969, Red No. 3 was approved for use in food based on the limited research available at the time. Two decades later, the cosmetics industry in the US petitioned the FDA to approve Red 3 so that it could be used in cosmetics and topical drugs.
Studies in the 1980s found that Red 3 increased the risk of thyroid cancer in rats. These findings prompted the FDA to ban its use in cosmetics and drugs, but, strangely, it remained approved for food products.
The 1958 Food Additives Amendment includes a provision known as the Delaney clause, which legally obligates the FDA to ban food additives that are shown to cause cancer in humans or animals. Red 3 meets this criterion, yet it continues to be used en masse.
Despite clear evidence of cancer risks, the FDA has failed to act on Red 3 for more than three decades. This prolonged inaction has raised questions about the agency’s priorities and its ability to enforce its own rules.
The FDA’s website argues that research linking Red 3 to cancer in rats has “limited relevance to humans.” This position has drawn criticism for downplaying potential risks and failing to uphold the health of citizens.
In 2021, the Center for Science in the Public Interest (CSPI), an advocacy group focused on improving the consumer system in the US, petitioned the FDA to ban Red No. 3. Ultimately, the agency decided to implement a nationwide ban.
In 2023, California passed legislation to ban Red 3 from food in the state by 2027. The bill includes considerations for the manufacture, delivery, and distribution of food products containing the additive.
A compilation of 25 studies found that synthetic dyes like Red 3 are linked to behavioral problems in children. Many studies used to approve synthetic dyes in the late 1900s are outdated, as they were not designed to detect neurobehavioral effects in children.
California’s ban on Red 3 is a reflection of the state’s frustration with the FDA’s failure to act, and it isn’t the only one to feel this way. Other states (including Washington and Missouri) are following suit, introducing legislation to address gaps in the federal food regulatory system and protect their residents.
Red 3 and other synthetic dyes are already banned or require warning labels in Europe and other regions. The European Food Safety Authority (EFSA) only allows Red 3 in pet foods and processed cherries.
California’s Red 3 ban is making waves across the US, since the state boasts the world’s fifth-largest economy. Companies are unlikely to produce separate products for California, which could lead to a nationwide shift away from this harmful dye.
Food manufacturers already produce dye-free products for stricter markets like Europe. California’s ban added pressure to extend safer practices to the United States. Red No. 3’s removal was not only feasible, it was long overdue.
California previously led the way in 2010 when it banned artificial trans fats, which prompted a ripple effect across the US. Similarly, the state’s action on Red 3 could accelerate nationwide changes in food manufacturing standards.
In the 1990s, artificial trans fats were linked to heart disease and strokes. The FDA took time to gather evidence, but California intervened earlier. It was only in 2018 that the FDA issued a nationwide ban.
Food dyes like Red 3 serve no practical purpose beyond enhancing visual appeal. They do not affect flavor, nutrition, or preservation, but they present a larger risk to human health that is especially unjustifiable.
California has long led the charge in protecting children from potentially harmful chemicals during critical developmental stages. Now, with the FDA’s nationwide ban on Red No. 3, the rest of the United States is finally following suit.
Sources: (Vox) (Center for Science in the Public Interest) (CBS News) (Britannica)
Red No. 3: the restricted cancer-causing dye that is still in your food
Manufacturers have until January 15, 2027, to stop using the coloring in food in the US
FOOD Additives
Back in January, the Food and Drug Administration (FDA) announced a nationwide ban on the artificial additive Red No. 3, also known as erythrosine, in all food and medications in the US.
The synthetic dye had already been banned from cosmetics, ingested drugs, and topical medications decades ago due to research linking it to behavioral issues in children, including ADHD. It has also been associated with thyroid cancer in animal studies.
Manufacturers now have until January 15, 2027, to stop using the coloring in food, and until January 18, 2028, for medication. In the meantime, it remains in use—making it all the more important to stay informed.
Click through this gallery to learn more about the potential harms of Red No. 3 and other synthetic dyes you may want to avoid.