The FDA has studied the use of caramel as a flavor and as a color additive in foods for decades. To ensure that the use of caramel colors in food continues to be safe, FDA is currently reviewing all available data on the safety of 4-methylimidazole (4-MEI), an impurity formed in some caramel colors at low levels during the manufacturing process. This safety analysis will help FDA determine what, if any, regulatory action needs to be taken. However, in the interim, FDA has no reason to believe that 4-MEI, at the levels expected in food from the use of caramel colors, poses a health risk to consumers.
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