Let's talk about Caramel Coloring and 4-MEI

We've all seen the recent news about yet another chemical in our food.  It's actually nothing new, since 4-MEI (4-methylimidazole) has been in cooked foods since we began using fire.  It is a byproduct of the normal heating and browning of foods and beverages and is produced by heat in almost all foods, including caramel coloring.  4-MEI itself is never added to foods or beverages.

What's all fuss about?

Just recently, Consumer Reports released a report on 4-MEI in caramel coloring that's been making its way around the media and around our offices here.  Their analysis of a small number of caramel-containing beverages showed some beverages that exceeded 29 micrograms of 4-MEI per 12-ounce can or bottle.  According to Consumer Reports, "While we cannot say that this violates California's Prop 65, we believe that these levels are too high..."  In fact, according to a number of experts, Consumer Reports does not understand the requirements of this California law, which allows for lifetime averaging of consumer exposure to carcinogens listed by the state.  A careful consumption analysis of the beverages in question shows that average consumers do not exceed 12 ounces of intake per day.      

What, if any, are the health risks associated with 4-MEI?

Experts acknowledge that 4-MEI was shown to be a potential carcinogen in a government cancer study of mice fed massive doses for their lifetimes.  These doses were actually thousands of times higher than what people consume in caramel-containing beverages.  In fact, tumors were increased only in the treated mice in the lung.  Similar massive doses fed to rats actually reduced the incidence of tumors in five organs, calling into question whether 4-MEI poses any cancer risk to humans at all.  IARC classifies 4-MeI as "possibly carcinogenic to humans," its lowest rating next to "probably not carcinogenic to humans."  Overall, FDA and other global health authorities agree there is "no reason to believe that there is any immediate or short-term danger presented by 4-MEI at the levels expected in food from the use of caramel coloring."

What do the experts have to say about the recent report?

Experts in the field of heat-formed contaminants ask the question of whether 4-MEI is a carcinogen and if the amount of 4-MEI in caramel is a health risk to consumers.  The answer is not as clear cut as Consumers Union would lead their readers to believe.  There is some question about the proper interpretation of the test results.  Nonetheless, all of the major international regulatory agencies and their scientific advisors, including, the US Food and Drug Administration, Health Canada, and the European Food Safety Authority (each representing scores of knowledgeable scientists) have said that current levels of 4-MEI in food do not present a health risk to consumers.

To use the Prop 65 level of 29 micrograms per day as a benchmark to suggest risks to consumers is inappropriate.  There is no scientific consensus that the animal data justifies that number. 

In my personal opinion, Consumers Union is doing a disservice to their readers by alarming them about a hypothetical risk that is very likely insignificant compared to other health risks from other dietary factors.  It is important to keep the negligible risk in mind.

So, what is FDA currently doing?

According to FDA, "based on the available information, FDA has no reason to believe that there is any immediate or short-term danger presented by 4-MEI at the levels expected in food from the use of caramel coloring."  However, to ensure that the use of caramel coloring in food continues to be safe, FDA is currently reviewing all available data on the safety of 4-MEI and is reassessing potential consumer exposure to 4-MEI from the caramel coloring in food products.  This safety analysis will help FDA determine what, if any, regulatory action needs to be taken.  But it should be noted that no agency, including FDA, is recommending that consumers change their diets because of concerns about 4-MEI. 

For more information about 4-MEI and caramel coloring, please visit the Q&A about Caramel Coloring and 4-MEI or the FDA website.