Caramel — or 4-Methylimidazole or mel-4 — is added to many popular colas to produce a brownish color. The substance is classified by the FDA as a food generally recognized as safe (GRAS).
Under FDA regulations, food additives must undergo premarket review and approval by the agency. However, ingredients classified as GRAS are given a free pass. As with other GRAS ingredients, caramel was given the classification decades ago. Because the FDA does not employ a reevaluation process, an ingredient that makes it onto the GRAS list may avoid further review of its health and safety implications.
Caramel was classified as GRAS in 1973. But, a 2007 study found that the coloring additive was possibly carcinogenic. California subsequently began requiring products that exposed consumers to 29 micrograms or more of Mel-4 per day to place a warning label on the packaging. In January 2014, Consumer Reports released an investigation that detected excessive amounts of caramel coloring in various products — including Pepsi, Diet Pepsi, Pepsi One and Malta Goya — in the New York area. Less food coloring was found in the California market.
PepsiCo claims that average consumption of soda is 100 milliliters per day, which equals less than one-third of a full 12-ounce can, and so consumers do not reach the harmful levels identified in the 2007 study. The typical cola bottle has grown to 20 ounces since caramel was added to the GRAS list in the 1970s. Although U.S. Food News did not conduct scientific testing on the subject, we have observed that most people drink a large portion of the big sodas they purchase in our presence, certainly more than the approximately 4 ounces estimated by the PepsiCo representative.
Limiting the amount of caramel in a single cola bottle assumes that consumers drink soda in moderation and are not consuming the additive elsewhere in their diets — for example, in beers, liquors, candies, vinegars, cough drops, breads and other processed foods. So, consumers may still be exposed to high levels of mel-4, even if the soda companies follow the guidelines established by California statute.
The Consumer Reports study should raise questions about the safety of heavy daily soda consumption. The findings should also make consumers think twice about eating other GRAS-designated ingredients. Some ingredients the FDA generally recognizes as safe may not be so safe after all.