Why is Red 40 banned in the US? Debunking a Common Nutrition Diet Myth

October 5, 2025 •

5 min read

Despite widespread rumors, Red 40, also known as Allura Red AC, is not banned in the US by the FDA. However, the question "Why is Red 40 banned in the US?" stems from significant public debate, varying international regulations, and specific recent state-level restrictions that highlight genuine food safety concerns.

Quick Summary

Red 40 is an FDA-approved petroleum-derived synthetic dye, widely used in US food and beverages, but controversy persists over its health effects. While not federally banned, concerns about hyperactivity, contaminants, and allergies have led some states and other countries to ban or require warning labels for it.

Key Points

Not Federally Banned: Red 40 is approved by the FDA for use in food, drugs, and cosmetics in the US, despite common rumors to the contrary.
Controversy over Hyperactivity: The dye is controversially linked to hyperactivity and other behavioral issues in a subset of sensitive children, including those with ADHD.
International Restrictions: The European Union requires warning labels for Red 40, while countries like Norway and Iceland have completely banned it.
Contains Carcinogenic Contaminants: Red 40 contains trace amounts of contaminants, like benzidine, which are known carcinogens.
State-Level Bans: Specific US states like California are implementing their own restrictions or bans on Red 40 and other synthetic dyes, starting with school meals.
Natural Alternatives Exist: Growing consumer demand has led many manufacturers to use natural colorants derived from sources like beets, paprika, and carmine.

The Surprising Truth: Red 40 and U.S. Federal Regulations

Many consumers are surprised to learn that FD&C Red No. 40, commonly known as Red 40, is not banned at the federal level in the United States. This widespread misconception is likely fueled by several factors, including the outright bans in other countries, the FDA's recent ban on a different red dye (Red 3), and new state-level regulations targeting synthetic food colorants. The FDA considers Red 40 safe for consumption within specific limits, a position based on decades of reviews. However, this stance remains highly controversial among some consumer groups, health advocates, and even some state governments, who argue that the potential risks outweigh the cosmetic benefits of the dye. This situation creates confusion for consumers trying to make informed decisions about their nutrition diet.

The real story involves a complex web of scientific studies, regulatory history, and differing international health philosophies. Unlike the recently banned Red 3—which was linked to cancer in lab animals—the evidence against Red 40 is more focused on neurobehavioral issues, particularly in children. Understanding this distinction is key to navigating the debate.

The Science Behind the Controversy: Hyperactivity in Children

One of the most persistent and well-documented concerns surrounding Red 40 is its potential link to hyperactivity and other behavioral issues in children. This topic gained significant attention following a major 2007 study published in The Lancet (often referred to as the Southampton study), which indicated that mixtures of artificial food colors and a preservative could increase hyperactivity in children. While the study's findings were not conclusive for the general population, they were compelling enough to trigger a different regulatory response in Europe.

Evidence linking Red 40 to behavioral changes includes:

Exacerbation of ADHD Symptoms: Numerous studies and clinical trials have suggested that removing synthetic food dyes, including Red 40, from the diets of sensitive children can lead to a reduction in ADHD-like symptoms such as hyperactivity, irritability, and impulsivity. While dyes do not cause ADHD, they may act as a trigger or exacerbating factor for a subset of children.
Neurobehavioral Effects in All Children: A 2021 report by California's Office of Environmental Health Hazard Assessment (OEHHA) reviewed evidence and concluded that synthetic food dyes can cause or worsen neurobehavioral problems in some children, both with and without existing behavioral disorders.
Potential Mechanism: Experts suggest that the link could be due to various factors, including dye-induced mineral depletion, chemical changes in the brain, or immune hypersensitivity leading to inflammation.

Health Concerns and Contaminants Associated with Red 40

Beyond behavioral effects, other health concerns have been raised regarding Red 40. Though the FDA certifies and regulates batches to ensure purity, some studies have identified potential contaminants in the production process. These include:

Benzidine: This is a known human and animal carcinogen that can contaminate the dye during manufacturing. While the amounts are small, critics argue that any amount of a known carcinogen is unacceptable in the food supply, especially when safer alternatives exist.
Allergic Reactions: Although rare, some individuals have reported allergic reactions or sensitivities to Red 40. Symptoms can range from hives, swelling, and itchiness to more severe, though infrequent, reactions involving the respiratory system.
Migraines and Digestive Issues: Certain individuals, particularly those already prone to sensitivities, may experience migraines, headaches, or digestive upset following consumption.

Regulatory Approaches: The US vs. International Standards

Regulatory bodies around the world have taken different stances on synthetic food dyes like Red 40. This is largely due to differing interpretations of scientific evidence and health philosophies.


Aspect	United States (FDA)	European Union (EFSA)	Norway & Iceland	California (State Law)
Current Status	Approved and legal for use within specific limits.	Approved, but requires a strict warning label.	Banned from food products entirely.	Ban in public schools (effective 2028), phased statewide restrictions.
Regulatory Philosophy	Relies on evidence of harm before restricting or banning.	Employs the "precautionary principle"—taking action even without conclusive proof of harm.	Strict precautionary principle, favoring natural alternatives.	Precautionary principle, restricting based on neurobehavioral concerns.
Labeling	Must be listed by name on ingredient labels (e.g., "Red 40").	Must carry a warning: "May have an adverse effect on activity and attention in children."	N/A, as it is banned.	N/A, phased out.
Impact on Companies	Drives voluntary reformulation to avoid controversy.	Motivates reformulation to avoid costly and negative warning labels.	Requires reformulation to natural alternatives for market entry.	Pressures manufacturers to reformulate products sold within the state.

Moving Towards Healthier Options: Natural Alternatives

Due to sustained consumer pressure, increasing regulations, and public awareness, many food manufacturers have started replacing synthetic dyes with natural colorants. A shift towards cleaner labels and more transparent ingredients benefits consumers seeking a healthier nutrition diet.

Common natural alternatives for red coloring include:

Beetroot Juice/Powder: Offers a vibrant pink to deep red hue and is widely used in snacks, dairy products, and candies.
Paprika Extract: Provides an orange-red color and is derived from sweet peppers.
Carmine: A bright red dye extracted from the cochineal insect. While natural, it is not suitable for vegetarian or vegan products and can sometimes cause allergic reactions in sensitive individuals.
Lycopene: Found in tomatoes and other red fruits, it provides a red pigment.
Purple Corn Anthocyanins: These pigments from purple corn can create a range of red to purple colors.

Conclusion: Staying Informed for a Better Nutrition Diet

In conclusion, the claim that Red 40 is banned in the US is a myth, but it's one rooted in legitimate concerns about synthetic food dyes and inconsistent global regulations. While the FDA currently maintains its stance that Red 40 is safe, increasing state-level action and long-standing international restrictions mean the controversy is far from over. For individuals sensitive to the dye or those who prefer to avoid petroleum-derived ingredients, reading labels carefully and choosing products with natural colorants remains the most effective strategy. Staying informed about food additives and regulatory changes is an important step towards making better choices for your nutrition diet and overall health.

Learn more about food additive controversies and safe alternatives from health organizations like the Center for Science in the Public Interest (CSPI).

Frequently Asked Questions

No, Red 40 is not banned across the entire European Union. However, due to concerns over its link to hyperactivity, the EU requires products containing Red 40 to carry a warning label stating, "May have an adverse effect on activity and attention in children".

The misconception likely stems from several factors, including the outright bans in some other countries, the FDA's recent ban on a different red dye (Red 3) in 2025, and new laws passed by individual US states restricting synthetic food colorants.

While the FDA considers it safe, studies suggest potential risks in some individuals, including exacerbating hyperactivity in sensitive children, rare allergic reactions, and headaches. Trace amounts of carcinogenic contaminants like benzidine have also been found.

No, Red 40 does not cause ADHD, which is a neurodevelopmental disorder. However, in a subset of children with ADHD or sensitivities, consuming Red 40 and other synthetic dyes may worsen existing symptoms of hyperactivity.

You can identify Red 40 by checking the ingredient list on a product's nutrition label. It may be listed as "Red 40," "FD&C Red No. 40," or "Allura Red AC".

Many food manufacturers use natural colorants instead of Red 40, such as beet juice or powder, paprika extract, carmine, lycopene, or purple corn anthocyanins.

The FDA banned Red 3 after animal studies in the 1980s linked high doses of the dye to thyroid cancer, a finding that, under the Delaney Clause, required its removal from food. The scientific evidence surrounding Red 40 has not been deemed sufficient by the FDA to warrant a similar federal ban.

While most research focuses on children, some studies suggest that adults with sensitivities may also experience adverse effects like headaches or allergic reactions. Those seeking a cleaner nutrition diet or with known sensitivities may choose to avoid it as well.