WASHINGTON -- A consumer watchdog group has asked the U.S. Food and Drug Administration to ban the use of caramel coloring in soft drinks, charging that the chemicals are a possible cancer risk. The FDA said it is reviewing the group's petition, but that the drinks are safe according to national standards.
The Center for Science in the Public Interest said in a petition to the FDA that it found unsafe levels of the chemical 4-methylimidazole (4-MEI) in cans of popular soda brands like Coke and Pepsi. The carcinogen is formed, the group explained, when ammonia or ammonia and sulfites are used to manufacture the caramel coloring that gives the sodas their distinctive brown colors.
The group said the 140 micrograms of 4-MEI found in a 12-fl. oz. serving of soda exceed by nearly five times the 29-microgram limit recommended by the state of California. At the beginning of this year, California health officials added 4-MEI to the list of "chemicals known to the state to cause cancer." This could result in cola brands being required to have cancer-warning labels.
CSPI estimated that the average amount of 4-MEI in soda translates to a lifetime cancer risk of 5 out of 100,000 people.
"If companies can make brown food coloring that is carcinogen-free, the industry should do that," said CSPI executive director Michael Jacobson. "Otherwise the FDA needs to protect consumers from this risk by banning the coloring."
The group also says the label is misleading. "Most people would interpret 'caramel coloring' to mean 'colored with caramel,' but this particular ingredient has little in common with ordinary caramel or caramel candy," Jacobson said. "It's a concentrated dark brown mixture of chemicals that simply does not occur in nature. Regular caramel isn't healthful, but at least it is not tainted with carcinogens."
This is the CSPI's second attempt to persuade the FDA to ban caramel coloring. The group had appealed to the government with the same request last year.
FDA spokesperson Doug Karas said a consumer would have to drink well over a thousand cans of soda a day to ingest the doses administered to rodents in the studies cited by CSPI that have asserted a link to cancer. The FDA limit for 4-MEI in caramel coloring is 250 parts per million.
The American Beverage Association issued a statement defending the safety of 4-MEI, dismissing CSPI's claims as scare tactics. "The science simply does not show that 4-MEI in foods or beverages is a threat to human health," ABA said. "In fact, findings of regulatory agencies worldwide, including the U.S. Food and Drug Administration, European Food Safety Authority and Health Canada, consider caramel coloring safe for use in foods and beverages. 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."
Following CSPI's petition to the FDA to ban it, and after California added the compound to its list of known carcinogens, Coca-Cola defended the safety of its products and said it is not changing its world-famous formula for Coke beverages. However, it has asked its caramel manufacturers to reduce the amount of 4-MEI used in their production processes.
The Coca-Cola Co. issued the following statement:
Extensive media coverage has been devoted in the past few days to some misconceptions about caramel and The Coca-Cola Company's beverages. We want to set the record straight, and be absolutely clear:
"The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Company is not changing the world-famous formula for our Coca-Cola beverages. Over the years, we have updated our manufacturing processes from time to time, but never altered our Secret Formula.
"We have asked our caramel manufacturers to modify their production process to reduce the amount of 4-MEI in the caramel, but that will have no effect on the formula or on the great-tasting, high-quality products that consumers expect from us. These modifications will not affect the color or taste of Coca-Cola.
"Our commitment to the highest quality and safety of our great brands remains our top priority. And we will continue to rely on sound, evidence-based science to ensure that our products are safe," The Coca-Cola Co. concluded.
Pepsi has been reported as saying it would be switching to a caramel coloring that uses less 4-MEI, first in California and then nationwide.