How Safe Are Color Additives?
By Dr. Linda M. Katz, Chief Medical Officer for the FDA’s Center for Food Safety and Applied Nutrition (CFSAN)
Without color additives, colas wouldn’t be brown, margarine wouldn’t be yellow, and mint ice cream wouldn’t be green. Here at the FDA, we’re committed to making sure the color additives in your food are safe.
Color additives are used in foods to:
- Offset color loss due to exposure to light, air, temperature extremes, moisture, or storage conditions
- Make natural variations in color look more uniform
- Enhance colors that occur naturally
- Provide color to colorless and “fun” foods, like those brightly colored popsicles that are perfect for beating the summer heat.
The FDA regulates color additives used in food and dietary supplements marketed in the United States. FDA is responsible for making sure all foods containing color additives are safe for consumption, contain only approved ingredients, and are properly labeled.
So how do we ensure that these colors are safe?
First of all, the FDA uses the best science available to determine whether there is “a reasonable certainty of no harm” to consumers when the color additive is used properly (at its intended level and for its intended purpose). When the FDA approves a color additive, the Agency issues strict requirements for it. Among other things, these requirements specify :
- The types of foods in which it can be used
- The maximum amounts allowed to be used
- How it should be identified on the food label
All color additives are subject to ongoing safety review as science and methods of testing continue to improve.
It is possible, but it is rare, to have an allergic-type reaction to a color additive. For example, in the 1980s, an FDA panel concluded that fewer than one of 10,000 people might experience itching or hives after consuming a food containing FD&C Yellow No. 5. This color additive is widely found in beverages, desserts, processed vegetables, candy, and other products. As with all certified colors, FD&C Yellow No. 5 must be listed on the food label – so that consumers who are sensitive to the color can avoid it.
There are times when the FDA learns that a food containing a color additive may be unsafe. For example, the food may contain a color additive that is prohibited, or the additive may be improperly identified on the packaging. In these situations, the FDA can issue a warning letter to the manufacturer, detain products before they are shipped to stores, or even seize products.
FDA continually monitors reports of problems that may be related to color additives. If you think that you have had an allergic or other kind of reaction to a color additive, phone the FDA at 301-436-2405.
Questions and Answers
Updated July 30, 2010
Q. What about the link between food additives and cancer? ADHD?
A. In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Color additives that FDA has found to cause cancer in animals or humans may not be used in FDA-regulated products marketed in the United States. For information, see this consumer update on color additives. As for ADHD, results on studies about a link between color additives and ADHD have been inconclusive, inconsistent, or difficult to interpret due to inadequacies in study design. For details, see “Do additives cause childhood hyperactivity?” in Food Ingredients and Colors.
This is a huge topic that has just been brought to light from the FDA. I treat children every day who have adverse reactions to food colors.
I don’t necessarily think that colorless food would prevent obesity but it would be a good step toward a healthier future for all of us. Great thoughtful post.
There has to be something in the foods causing these diseases. Dyes and pesticides have to be revisited, in finding harmful effects on people. Since, I'm cancer free, I've talk with hundreds of people who know someone or they have experienced cancer first hand. I don't think we need more regulations, instead, let's enforce the regulations that are already there.
Since I have such an active interest in food, I enjoyed this factual info.
Take your child off of popsicles, kool-aid, processed fruit treats and refined sugar. You will find a much calmer and "grounded" child. It isn't simple, it isn't easy, but slowly removing processed foods can make your life healthier and your child less anxious and happier.
Chemical food coloring is not safe! Why are they banned in other countries???? Americans rank very low in the world in health and are very sick....don't you think food and all the additives allowed in food has something to do with it?? There is nothing healthy and safe about having lots of chemicals in our food. No matter what research you do, food additives are not food and our bodies are not meant to eat that....
I notice that when my children eat foods colored with blue and red dyes that they become extremely hyper and distracted. I have tried to avoid buying food with added colors but it is so hard because so many foods contain them...even things such as mayonaise have yellow dye. I do not think we should have colorings or any other additives and preservatives....just make foods from their natural ingredients. With all the children coming down with allergies, autisim, ADHD and other "disorders," I really think our foods should be studied much more thoroughly. I think the FDA is overworked and understaffed to keep up with all the foods and beverages being made. Do we really need all the blue yogurt, red beverages, multi-colored ice creams etc...let's get back to what is best for our health! Keep things natural and make these foods cheaper then the unnatural foods.
I don't want color added to my food. What's wrong with the natural color - even if it is clear? That is why so many of us pay more to shop at Whole Foods and organic markets. We want our food natural. When I was a child, a childfood friend came down with luekemia and died. I always wondered if it was because his mother added color to everything.
What about the link between food color additives and cancer? ADHD? Obviously one exposure does not warrant concern but multiple exposures over a lifetime can add up. Thanks for any additional input you can provide related to this specific question.
I must say that it is great to see the FDA sending out this type of proactive positive statement concerning what FDA does to insure the safety of color additives. I think the FDA does a great job in sticking to the science and not getting tied up in all the non-scientific precautionary principle negative stuff that seems to be going on right now in Europe and in some of the U.S. media, especially related to that ridiculous unscientific report recently published by CSPI about synthetic colors. CSPI should be ashamed of what they wrote and the way they twisted the facts in the various studies which have been run to try to show what they wanted which is totally different than what the actual study director's conclusions may have shown who were involved in the study. The study director knows best how to interpret the data. The bottom line is that the FDA does a great job of looking at the real data in the various studies and in establishing appropriate regulations to control the safety to U.S. consumers when using products colored with synthetic colors. The synthetic colors approved in the U.S. have been more thoroughly studied than almost any of the food additives curerently in use and time after time they keep coming out as safe regardless of whether the FDA or European regulators (EFSA) review the data. There simply is no credible scientific data which has shown these colors to be unsafe or that they cause significant hyperactivity or allergenicity regardless of what some of the critics like CSPI would like the public to think. Yes, there may a few cases where there has been an effect but this is the case with almost all food ingredients. Synthetic colors are no different! This can easily be handled through appropriate labeling. There is no safety problem!!! The crazy calls that some people are making to ban these synthetic colors just show how little they really understand about the science. So much was made of the Southampton study in the European media that consumers in Europe have become scared of these colors when they certainly shoudn't be. The Southampton study was totally bogus in the way it was designed and did not show in any credible way that children's hyperactivity is really connected to the use of certain synthetic colors. However, the guy who ran the study sure got alot of media play which I assume was his goal and managed to unjustifiably scare the public. He probably was able to get more funding now though because of his fame. FDA and European regulators all said that the Southampton study design was flawed and that there was no real evidence of hyperactivity being caused by the colors. Yet, these comments were ignored by the media and politicians in the European Parliament and they went forward with a stupid label requirement which says there is a problem with the colors. This is nuts!!! Science needs to rule the day!! And for those who think that the ideal world would be to use "natural" colors, don't kid yourself. Many of these colors have not been studied nearly as intensively for safety as the synthetic colors have been and these colors simply do not work in many food applications due to the type of processing that must be done. The stablility of most of the "natural" colors is very poor! Additionally, these colors are significantly more expensive than synthetic colors and there is a fairly small supply of these colors worldwide compared to the demand. There is simply no way that these colors could replace synthetic colors in all uses worldwide even if everyone wanted them to. There is just not enough of a supply available to even think about this. To sum up....Thank you FDA for making the statements you did in this blog about the safety of food colors and I certainly hope that you continue to "stick to the science" when determining how best to regulate these ingredients going forward. Don't break down to pressure from crazy consumer groups and politicians who don't understand the real science in the studies which have been done. Thank you for the opportunity to comment.