Pepsi Plans to Drop Disputed Cancer Chemical

A report released just before July 4th by an environmental group seems to have gotten lost in the holiday weekend haze, despite findings that link cola and cancer. Pepsi (PEP) continues to sell sodas made with4-methylimidazole, or 4-MEI—ruled a carcinogen last year by the state of California—according to the Center For Environmental Health.  

The nonprofit group noted that Pepsi sold inside California had been reformulated to comply with state rules about the substance, yet drinks sold outside the state continue to include higher amounts of 4-MEI, which helps give the company’s cola drinks their caramel hue. The group found little to no 4-MEI in Coca-Cola (KO), which has switched to a modified caramel coloring.

In a response published in the Center for Environmental Health’s report, PepsiCo said its “coloring suppliers have been working on modifying the manufacturing process to reduce the amount of 4-MEI,” adding that drinks sold in the rest of the U.S. will have reduced levels of the chemical “by February 2014.”

In a statement issued on Friday afternoon, the company elaborated: “We strongly refute any claim that any product we sell anywhere is unsafe. The safety of our products is PepsiCo’s top priority, and we abide by the regulatory guidelines everywhere we do business,” PepsiCo said. “While we meet the strict FDA guidelines, when the regulatory requirements changed in California PepsiCo moved immediately to meet the new requirements and, in order to maintain a harmonized supply chain, globally committed to rolling out the changes across the rest of the U.S. and internationally.”

What exactly is 4-MEI? It’s a compound formed during the production of some caramel coloring agents and is found in colas, beers, soy sauces, breads, and coffee, according to the California Office of Environmental Health Hazard Assessment. Under a state law called Proposition 65, California requires manufacturers to label toxic substances. And the state added 4-MEI to its list last year after “studies published in 2007 by the federal government’s National Toxicology Program showed that long-term exposure to 4-MEI resulted in increases in lung cancer in male and female mice,” the state environmental website said.

Aside from cola, the Center for Environmental Health did not find high levels of 4-MEI in other products, in part because people generally consume more soda than, say, soy sauce, says Charles Margulis, a spokesman for the group.

Federal regulators haven’t yet sounded any alarms about 4-MEI. In an e-mailed statement, the the U.S. Food and Drug Administration explained the disparity between California rules this way: “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.”

Last year, FDA spokesman Douglas Karas said a person would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents. The American Beverage Association denied the harmfulness of 4-MEI in 2012.

Still, the FDA says it “is currently reviewing” data on the chemical and its relationship to cancer to determine “what, if any, regulatory action needs to be taken.”