Red 40 is one of the most controversial ingredients in our food supply. It isn’t obvious how this food dye is made or whether it’s acceptable for vegan diets, and claims about its risks to health and safety abound.
Is Red 40 vegan, and is it safe to consume? As a registered dietitian, I’ll discuss the most current evidence on this food additive so you can make the most informed decision for the health of yourself and your family.
What is Red 40?
Red 40 is a synthetic food dye used around the globe to make foods more visually appealing. It’s an azo dye made from petroleum and is also known by its other names: Allura Red AC (European Union), E129, FD&C Red 40 (United States), and Red 40 Lake.
In the United States, FD&C Red 40 is approved by the FDA1 for use as a food additive in:
- Dairy products
- Confections (sweets)
Be careful not to confuse Red 40 with carmine, also known as cochineal extract or natural red 4, which is made from the bright red shells of cochineal beetles.
Is Red 40 vegan?
Natural food dyes can be made from animals, but synthetic dyes are not. Most vegans consider Red 40 to be vegan-friendly since it isn’t made from or processed with animal-based ingredients.
One thing to note, however, is that Red 40 was tested on animals to determine its safety profile prior to FDA approval. Because of this, a minority of vegans prefer to avoid it. Continued animal testing is not required after FDA approval, however, so consuming foods with Red 40 does not harm laboratory animals.
Any continued animal testing is done by independent researchers testing their own scientific hypotheses. It isn’t required for the continued use of Red 40 in the food supply. Considering this, most vegans are okay with Red 40 from the perspective of avoiding animal cruelty.
Red 40 isn’t very common in vegan foods since most of the foods approved to use it as a food additive are non-vegan. This includes most breakfast cereals, Jell-O, puddings, and dairy products with Red 40. For vegans, Red 40 is most likely to pop up in commercial baked goods and beverages like sodas, colored sports drinks, and powdered lemonade, iced tea, and Kool-Aid drink mixes.
Red 40 is approved in both the United States and the European Union. According to the FDA, Red 40 is safe when consumed in amounts approved for food.
Although it’s made from petroleum, Red 40 is tested to make sure that no traces of petroleum are present in the final product.
The Joint FAO/WHO Expert Committee on Food Additives3 (JECFA) reevaluated the safety of Red 40 in 2016. It confirmed that intakes of Red 40 less than 7 milligrams for every kilogram of body weight are safe and don’t pose a health concern for children or any other age groups.
The Environmental Protection Agency4 (EPA) agrees, stating that Red 40 is of low concern based on experimental and modeled data.
As an artificial food dye, Red 40 is subject to batch certification5. This process ensures that each new batch undergoes chemical analysis testing to make sure that any contaminants are below the legally acceptable limit.
Despite these conclusions, Red 40 remains a highly controversial ingredient. Most concerns stem from claims that Red 40 is carcinogenic, contributes to behavioral problems like Attention-Deficit/Hyperactivity Disorder (ADHD) and hyperactivity in children, and causes allergic reactions.
Is there evidence to support these concerns? Let’s discuss each in more detail.
Concerns about Red 40 causing cancer stem from the fact that it contains certain carcinogenic compounds2 like benzidine. However, there isn’t any convincing evidence that Red 40 causes cancer in humans, especially when consumed in normal amounts present in food.
In other words, it’s the dose that makes the poison. The amounts of any carcinogenic compounds in Red 40 are likely far too low to actually lead to the formation of cancerous cells in the body.
Behavioral issues in children
A 2012 meta-analysis6 estimated that 8% of children with ADHD may experience exacerbated symptoms when consuming food dyes and that eliminating synthetic food dyes from the diet may be effective for some children.
A significant limitation of this meta-analysis that isn’t often discussed, however, is that the elimination diets that were reviewed often restricted combinations of different artificial colors and sometimes other ingredients as well, so it isn’t clear how much of the benefit was from eliminating Red 40 itself. These studies also included very small numbers of participants, making it difficult to know how reliable the results were.
The FDA does agree that while most children are not negatively impacted by artificial food colors, some children may be sensitive to them. They plan to evaluate new research as it becomes available.
More recently, in 2021 the California Environmental Protection Agency conducted an assessment5 of the neurobehavioral effects of synthetic food dyes in children. They concluded that synthetic food dyes can indeed impact neurobehavior in children with or without pre-existing neurobehavioral conditions like ADHD.
It’s difficult to tell, however, how much of this potential effect is due to Red 40 itself since most studies tested a combination of different food dyes at once, not individual dyes. It also isn’t clear how much Red 40 is needed to have an effect on behavior.
One thing is clear: more research is needed before we can confidently say how Red 40 impacts behavior in children. There certainly isn’t enough evidence to claim that Red 40 causes ADHD or hyperactivity at this time.
Considering the lack of quality evidence on this topic, the most prudent thing for parents to do may be to avoid Red 40 if they notice that their child is sensitive to it. So far, it seems that only a very small percentage of children with ADHD (about 8%) may be negatively affected.
Another common concern about Red 40 is the potential for allergic reactions. While it’s possible to be allergic to Red 40, reactions are very rare.
According to a 2017 study7 published in Food Chemistry, people who are allergic to artificial food colors experience mild skin reactions most of the time, with anaphylaxis occurring only rarely.
Red 40 is a vegan-friendly synthetic food color that is safe for most people when consumed in amounts approved by the FDA for use in food. Animal testing is no longer required since it has been FDA-approved.
Overall, most claims about Red 40 being harmful aren’t supported by the scientific evidence to date. To sum up:
- There is no evidence that Red 40 causes cancer in humans
- Red 40 is safe for the vast majority of children but may worsen ADHD or hyperactivity symptoms in a small subset of children
- Allergic reactions to Red 40 are possible, but rare
It’s probably prudent for vegans (and omnivores) to limit their consumption of Red 40 — not because it’s dangerous, but because Red 40 is found most often in sugar-sweetened beverages and commercial baked goods. These foods can be a delicious treat but are best consumed in limited amounts.
To reduce your risk for cancer, eating a plant-based diet rich in fruits, vegetables, whole grains, nuts, beans, and legumes will likely be much more effective than stressing over the occasional consumption of Red 40.
What red dye is not vegan?
Carmine is a red dye that isn’t vegan since it’s made from cochineal beetles. It’s also known as cochineal extract, natural red 4, or its E number E120.
Is red 4 dye vegan?
As a synthetic dye, Red #4 is vegan since it isn’t made from or produced with animal products. Red #4 was banned by the FDA8 in 1976 for use in food but is still allowed in topical drugs and cosmetics.
What is red dye 40 found in?
The FDA has approved red dye 40 as a food additive for cereals, gelatins, pudding, beverages, sweets/confections, and dairy products.
The scientific information in this article was accurate at the time of publishing but may change over time as new research becomes available.
- U.S. Food and Drug Administration. Color additives questions and answers for consumers. FDA website. Accessed 10/13/23.
- Kobylewski S, Jacobson MF. Toxicology of food dyes. Int J Occup Environ Health. 2012;18(3):220-246. doi:10.1179/1077352512Z.00000000034
- World Health Organization. Allura red AC. Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). WHO website. Accessed 10/13/23.
- United States Environmental Protection Agency. Safer chemical ingredients list. EPA website. Accessed 10/13/23.
- CalEPA OEHHA. Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children. April 2021.
- Nigg JT, Lewis K, Edinger T, Falk M. Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. J Am Acad Child Adolesc Psychiatry. 2012;51(1):86-97.e8. doi:10.1016/j.jaac.2011.10.015
- Feketea G, Tsabouri S. Common food colorants and allergic reactions in children: Myth or reality?. Food Chem. 2017;230:578-588. doi:10.1016/j.foodchem.2017.03.043
- U.S. Food and Drug Administration. Color additive status list. FDA website. Accessed 10/13/23.