Cola’s Making Headlines

This article, entitled "Cola’s Making Headlines," comes from Carolyn O'Neil at

On January 23rd, Consumer Reports posted an article titled "Caramel Color: The health risk that may be in your soda." The FDA also released today its plans to conduct new studies on the safety of 4-methylimidazole (4-MEI), the chemical compound that gives your most beloved foods and drinks (i.e. cola, breads, coffee, etc.) that caramel coloring. Previous FDA research of 4-MEI did not identify any health or safety risks.

As with many seemingly simple food topics, once you dig a little deeper you find a complicated array of information that creates a lot of questions. So, we’re breaking down the subject of 4-MEI to better understand the recent buzz.

What is 4-methylimidazole (4-MEI)?

4-MEI is a chemical compound created as a byproduct in some foods and beverages during the cooking process. It can also form during the manufacturing process of some caramel colorings.

Why are people worried about 4-MEI?

While current FDA research has found no identifiable health risk, the FDA announced it would be conducting new studies on the safety of Class III and Class IV caramel coloring.

In 2007, the National Toxicology Program (NTP) issued a report on a study of the effects of 4-MEI in rats and mice. The two-year study showed an increased incidence of certain lung tumors in mice, but the study was inconclusive. It is important to note that these NTP studies used levels of 4-MEI that far exceed current estimates of human exposure to 4-MEI from the consumption of Class III and Class IV caramel coloring in food products such as colas. In other words, you would have to drink great quantities of cola or coffee to achieve those levels.

What food products contain caramel coloring?

Any foods that contain added coloring must be listed as Artificial Colors in the ingredient label, but Artificial Color is not exclusive to caramel coloring. Also, Class I and Class II caramel coloring do not contain 4-MEI.

What is FDA doing about the presence of 4-MEI in caramel coloring?

The FDA is in the process of reviewing all available data on the safety of 4-MEI and the potential for exposure to 4-MEI from the use of Class III and Class IV caramel coloring in food products. The results of this analysis will help the FDA determine what, if any, regulatory action needs to be taken. In the meantime, FDA is not recommending that consumers change their diets because of concerns about 4-MEI.

Can 4-MEI be eliminated from food products?

Eliminating all 4-MEI in food is virtually impossible. However, in the case of caramel coloring, companies can take steps to reduce its formation during the manufacturing process.

Source: United States Food and Drug Administration

Expert Insight
For perspective on the topic, we reached out to Dr. Ronald Kleinman, Physician in Chief, Massachusetts General Hospital for Children; Chair of the Department of Pediatrics at Massachusetts General Hospital, and Charles Wilder Professor of Pediatrics at Harvard Medical School.

Dr. Kleinman: "My own take is that we should wait for the new FDA review."

About the Author...
Best Food Facts
Best Food Facts gives you the opportunity to connect with food system experts around the country who have done the research, checked their work and want to share the results.

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