Following a recently released study by Consumer Reports that found 12 brands of soda to have varying and sometimes "dangerous" levels of 4-methylimidazole — an impurity found in some caramel coloring, the Food and Drug Administration announced this week that they will take a second look at the safety of the additive even though their first review found no reason to believe that the coloring added to sodas is unsafe.
The FDA says it has studied the use of caramel as a flavor and color additive for decades, but will review new data on the safety of 4-methylimidazole.
“These efforts will inform the FDA’s safety analysis and will help the agency determine what, if any, regulatory action needs to be taken,” said FDA spokeswoman Juli Putnam.
There are no federal limits on the amount of 4-methylimidazole in food and drink. The substance is formed in some caramel coloring at low levels during the manufacturing process. The FDA says it also can occur in trace amounts when coffee beans are roasted or some meats are grilled.
Though studies have not been conclusive about whether 4-methylimidazole is a carcinogen, California includes it on the state list of carcinogens and a state law mandates a cancer warning label on products that have a certain level of the substance. In reaction to that law, Coke, Pepsi and other soft drink makers have directed their caramel-color suppliers to reduce the levels of 4-methylimidazole. It is not found in all caramel colorings.
Over an eight-month period, the Consumer Reports study found that single 12-ounce servings of two beverages purchased in California, Pepsi One and Malta Goya, exceeded the 29 micrograms of 4-methylimidazole that are the threshold per day in California but carried no warning.
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