Exploring the Controversy Behind Red Dye No. 3 and What, if Any, Potential Impact it Will Have on Public Health
A significant shift in food safety is on the horizon—one that could possibly impact the health of millions of Americans. But will it really make much of a difference in improving our overall health?
On January 15, 2025, the U.S. Food and Drug Administration (FDA) decided to ban FD&C Red No. 3 (also known as Red Dye No. 3, Red Dye 3, or erythrosine) in food, beverages, and oral medications. I’ll refer to it primarily as red dye 3 in this article for simplicity’s sake. The ban is to take place by 2027, allowing food and pharmaceutical companies time to find more natural colorants to replace red dye 3 in their products.
This artificial dye, approved for use as an ingredient in food in 1969, has long been controversial due to its potential health risks. The FDA’s decision is rooted in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FDCA), which mandates the prohibition of food additives shown to cause cancer in humans or animals.
For history buffs, the Delaney Clause, introduced by U.S. Representative James Delaney and passed in 1958 as part of the Food Additives Amendment, was designed to regulate the growing use of synthetic chemicals in the American food supply. During that era, additives were widely used to enhance flavor and extend shelf life, but concerns arose about their potential carcinogenic effects. The clause established a zero-tolerance policy, requiring the FDA to ban and remove any food additive found to cause cancer in laboratory studies.
What is Red Dye 3?
Very likely at some point in our lives, all of us have eaten a food, drank a beverage, or swallowed a supplement or oral medication that also contained red dye 3. But what exactly is red dye 3?
Red dye 3 is a synthetic petroleum-based dye that is very effective for the reason why it’s been used in our food system since 1969 – it dyes foods or beverages a bright, cherry-red color making it look “pretty” or more inviting to eat or drink. For example, foods that have commonly used red dye 3 include the following:
- Brach’s Conversation Hearts and Brach’s Candy Corn
- Baked goods like cakes, cupcakes, cookies, toaster pastries, and decorative icings/frostings
- Frozen treats such as ice cream, frozen yogurt, and popsicles
- Dairy products like strawberry milk
- Fruit products like maraschino cherries often found cans of fruit cocktail
- Beverages such as soda and juice
- Pharmaceutical products like food supplements such as gummy vitamins and cough syrups
Food manufacturers use food additives for numerous reasons: it might be to increase the shelf life of products, enrich nutrient content, improve the quality (preventing spoilage or enhancing the texture of a food), improve the safety of food, to flavor foods, and to enhance the color of foods.
The additives used for coloring a food are scrutinized the most. That’s because this type of additive is primarily used for making the food look fun and appealing, and not to make a food safer, increase its shelf life, or improve nutrient quality.
What is the reason for the ban and removal of red dye 3 in our food supply?
The FDA reviewed a 2022 petition by an environmental working group and found that high doses of red dye 3 caused cancer in male lab rats due to a hormone-related effect specific to them. However, studies in other animals and humans did not show the same risk, and there is no evidence that red dye 3 causes cancer in people.
The specifics of this research driving this decision was from studies conducted in the 1980s that involved male rats given very high levels of red dye 3 daily for months and were found to develop thyroid cancer. The amount of the dye the rats ingested was about 4% of their body weight. To put this into perspective, a person weighing 150 pounds, this amount would be equivalent to eating every day, 102 grams of red dye 3. In comparison, the average American’s intake or exposure of red dye 3, is 0.2 milligrams per day which is 7,500 times less than the doses tested in these studies.
It’s important to be aware that advocacy groups often overstate the health risks of additives and substances such as synthetic food dyes. Many of these entities, including the environmental working group, create their own quota of “safe intake levels” of different ingredients that are far below the levels that scientific research has found to be safe.
Keep in mind that the levels of red dye 3 in food are extremely low and are not associated with harm to humans. This decision to ban red dye 3 is based on regulatory and precautionary reasons, and not as a response to an immediate threat or health risk.
Besides red dye 3, there is also another synthetic red dye still in use, called red dye 40. Why is red dye 40 not being banned also? The reason is that they are chemically different and distinct dyes. Red dye 3 caused cancer in male rats whereas red dye 40 has not shown any link or has shown any demonstration of similar effects in animal studies. Therefore, it is still being used and permitted in foods, beverages, and pharmaceutical products under U.S. regulations.
How many other food dyes are still approved and in use in the U.S. food system?
Currently, there are 9 color additives approved by the FDA for use in food. Of these 9 color additives, red dye 40, yellow no. 5 and yellow no. 6 are used in about 90% of the artificial food dyes used in products sold in the U.S., according to the Centers for Science in the Public Interest.
While these dyes are considered safe under FDA regulations, because of the recent ‘chatter’ and concern on social media over color additives added in our food supply, the American consumer is becoming increasingly wary of any products containing artificial dyes. Many of the concerns voiced by consumers is over studies that have suggested links between artificial dyes and hyperactivity or allergic reactions in children. These growing worries has resulted in the state of California to lead the charge with stricter regulations on artificial dyes. Beginning in 2027, California will no longer allow certain food colorings in their public schools. These food colorings include red no. 40, green no. 3, blue no. 1 and 2, and yellow no. 5 and 6.
The action taken by California on banning these food colorings in California public schools, could signal a shift towards broader restrictions on synthetic dyes in the future, depending on consumer demand for using natural ingredients to use in place of synthetic dyes.
Why do some countries ban artificial dyes altogether?
Depending on the country, regulatory approaches vary. This is especially true in Europe where regulations on food additives tend to be stricter than in other countries around the world. For instance, the European Union (EU) requires warning labels on foods containing certain dyes which has led to many manufacturers to switch to natural alternatives. These bans have been based on a variety of reasons:
- Health concerns such as hyperactivity in children, potential of triggering an allergic reaction, or concerns over long-term safety in humans.
- Environmental impact concerns such as the production and disposal of artificial dyes leading to water pollution and chemical waste.
- Making the decision to favor natural colorants like beet juice, turmeric, and spirulina to provide vibrant colors without the potential risk of synthetic dyes.
What can consumers do who want to avoid using products with synthetic/artificial dyes?
Avoiding synthetic/artificial dyes in food can be easier than it seems! Here are some tips that can help consumers:
- Read Ingredient Labels: Start by checking food labels for any artificial food colors, such as Red 40, Yellow 5, Blue 1, etc. These are often listed as specific color additives. Choose foods using natural colorants like beet powder/juice, turmeric, carmine, or turmeric.
- Choose whole, unprocessed foods most of the time: Fresh fruits, vegetables, meats, and grains do not use artificial dyes.
- Opt for organic products: Many, but not all, organic food brands avoid synthetic food dyed and instead use natural coloring agents.
- Make snacks from scratch: Prepare snacks like smoothies on your own, making you in charge of controlling the ingredients.
- Buy brands that offer “clean” or “free from” terminology that often exclude using artificial dyes or colors.
- Check for label terminology stating “natural” or “vegetable” dyes
Will the removal of red dye 3 significantly improve public health?
Here’s the most important question and here’s my short response – not likely, unless other changes in regard to food choices/eating habits are made and embraced by consumers. Let me explain.
The foods containing red dye 3 like candy and cake frosting, are not nutritionally significant or make up a substantial portion of what we eat. Removing one ingredient, like red dye 3, will not improve that foods overall nutritional value of a maraschino cherry or strawberry milk, for instance.
This switch to an alternative coloring may actually result in an increased food cost. The food manufacturer or pharmaceutical company will comply with this ban but, will likely use, naturally-derived coloring that may be less stable and more expensive, jacking up the food price. But that remains to be seen.
To be clear, I’m not against this ban on red dye 3. Suppose it makes people have more confidence in our food supply, all the better. However, it’s not going to be the magic trick moving the trajectory in the right direction of fixing chronic disease and obesity in our country.
What is the real challenge we face in improving our health within the U.S. food system?
I believe that the biggest food challenge we have in the U.S. food system are far broader than concerns over synthetic food dyes. Here’s why:
- 90% of Americans don’t meet the daily recommendations for fiber
- Over 40% of Americans are deficient in vitamin D.
- More than 13% of Americans are deficient in vitamin B6
- More than 7% of Americans are vitamin C deficient.
- Other common nutritional deficiencies in the U.S. include calcium, essential fatty acids, folic acid, iron, magnesium, vitamins A and B12.
- Around 40% of Americans report skipping at least one meal per day, with breakfast being the most commonly skipped meal. Skipping meals makes it more difficult to meet daily nutritional needs promoting good health.
Each of these nutritional deficiencies are critical nutrients needed for our best health that play critical roles in bodily functions. When a person is considered to have a nutrient deficiency, depending on which nutrient it is, this has the potential to lead to chronic health issues like fatigue, osteoporosis, high blood pressure, night blindness, obesity, impaired immunity, cardiovascular disease, and some forms of cancer.
Achieving and then sustaining good health is complex. While removing a single dye from our food system is a regulatory win, it will do little to practically nothing for improving public health. Demonizing a single ingredient and linking it without adequate science to poor health outcomes or chronic disease, is an oversimplification to a complex situation.
It’s important to know that red dye 3 is unlikely to cause cancer in humans or other health issues on its own.
What matters most is that the totality of your diet – your day-in and day-out eating patterns – along with your genetics and then living a healthy lifestyle, matter – a lot. Living a healthy lifestyle means you take the time and initiative to include regular exercise, time spent outdoors, get adequate sleep, having techniques to deal with stress, and refraining from use of all tobacco products. Every single one of these practices are valuable contributing factors in achieving great health. These changes won’t happen overnight though. If you already do a majority of these practices, perfect. If not and you need help, choose one to work on and add in others as they become a natural part of your lifestyle.
For example, if you need to reduce your sodium intake due to congestive heart failure, start by reading the Nutrition Facts Label on packaged foods. Choose foods with fewer than 250 milligrams of sodium per serving size. Or, cut back on eating out – instead of three times a week, eat out only once weekly or every other week. Small changes like this, add up over time. Ask your healthcare provider for a referral to a registered dietitian, nutrition professionals trained to work with patients on developing an individualized eating plan. It takes being consistent in practicing them and making your health a priority, no matter what, to achieve your health goals.
To help get you started towards eating a more whole foods diet plan, here are simple suggestions to try. Begin by choosing one or two goals to meet:
- Aim to consume at about 25-30 grams of fiber each day – fiber is found only in plant-based foods like beans, lentils, whole grains, nuts, fruits and vegetables.
- Have a fruit and/or vegetable at every meal and snack.
- Avoid all sugary beverages
- Drink more water – aim to drink at least half your body weight in ounces.
- If you drink alcoholic beverages, limit your intake to no more than one drink per day for women and two drinks per day for men.
- Have between 25-30 grams of protein at each meal and between 5-10 grams of protein at a snack.
- Choose at least 2-3 servings of a dairy food every day including milk, Greek yogurt, cottage cheese or kefir.
- Daily use healthy fats such as extra-virgin olive oil, avocados, nuts, and fatty fish like salmon or tuna.
Imagine the incredible transformation we could see if every single one of us – men, women, and children embraced these practices – our nation would be healthier, stronger, and thriving like never before!
It’s up to each one of us to do what we can to make it happen.
References:
- The Delaney Clause: https://www.ncbi.nlm.nih.gov/books/NBK216642/
- 1988 study of male rats and red dye 3: https://pmc.ncbi.nlm.nih.gov/articles/PMC5917475/
- Study showing skipping meals may increase cardiovascular disease: https://www.jandonline.org/article/S2212-2672(22)00874-7/fulltext#:~:text=The%20prevalence%20of%20skipping%20breakfast%2C%20lunch%2C%20and,among%20populations%20aged%2020%20to%2074%20years.
- Understanding Nutrition Facts Labels: https://www.fda.gov/food/nutrition-facts-label/how-understand-and-use-nutrition-facts-label
- Find a Nutrition Expert: https://www.eatright.org/find-a-nutrition-expert