The average amount of 4-MI found in a 12-ounce can for Coke and Pepsi drinks was nearly five times California’s 29-micrograms-per-day limit

They're arguably the world's two most popular beverages and each accounts for several billion individual servings sold per day. Yet this week the corporate behemoths behind Coca-Cola and Pepsi quietly agreed to comply with a new regulatory requirement in California to either carry a cancer warning label if their products included certain levels of a carcinogenic chemical or reduce those chemical levels significantly. The beverage giants chose to cut down on the chemical.

The action marks a major success for the Centre for Science in the Public Interest, a non-profit watchdog and consumer advocacy group, which has for many months now campaigned vigorously to get the United States Food and Drug Administration to recognise that the compound 4-methylimidazole, also listed as 4-MI or 4-MEI, as a known carcinogen. Last year, the FDA acceded and added 4-MI to its carcinogen list.

This week the CSPI dashed off another letter to the FDA following laboratory experiments that showed that 4-MI and a chemical cousin called 2-MI, both of which Coke and Pepsi use to produce their classic caramel colour, were found to be carcinogenic in animal studies.

Michael Jacobson, Executive Director of CSPI, said in the letter that the FDA “has done nothing in the past year to protect the millions of consumers who have been consuming dangerously contaminated soft drinks and possibly other products with ammoniated caramel colourings”.

To clarify the risks posed by this artificial colouring agent used by Coca-Cola and Pepsi, the CSPI tested a range of ultra-popular drinks in the U.S. including Coca-Cola, Diet Coke, Pepsi-Cola, Diet Pepsi, Dr Pepper, Diet Dr Pepper and Whole Foods' 365 Cola. The average amount of 4-MI found in a 12-ounce can for Coke and Pepsi drinks was 138 micrograms, which was nearly five times California's 29-micrograms-per-day limit, “indicating a lifetime cancer risk of five out of 100,000 people,” CSPI said.

Warning that this cancer risk could rise to 13 cancers per 100,000 if only people consuming soft drinks containing caramel colouring were considered, Dr. Jacobson said the Coca-Cola Corporation and PepsiCo had switched to lower-concentration 4-MI formulations due to California's Proposition 65 law based on the State's Safe Drinking Water and Toxic Enforcement Act of 1986. However, Dr. Jacobson noted that the levels of 4-MI may exceed the FDA's one-in-a-million standard even with the new formulation.

In an angry response, the American Beverage Association, an industry body, hit back at the CSPI study saying, “This is nothing more than CSPI scare tactics, and their claims are outrageous. The science simply does not show that 4-MEI, in foods or beverages, is a threat to human health... CSPI fraudulently claims to be operating in the interest of the public's health when it is clear its only motivation is to scare the American people.”

As the ultimate arbiter, the jury still seems to be out at the FDA. Its spokesman, Douglas Karas, was quoted as saying in a statement that the FDA was currently reviewing the CSPI petition, but “it is important to understand that a consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents”.

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