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Consumer Reports Study Prompts FDA to Reexamine Caramel Coloring

The U.S. Food and Drug Administration plans to take a closer look at the caramel coloring added to certain soft drinks and other food and beverage products because of a potentially cancer-causing byproduct they may contain.

The federal agency’s move was in response to a new Consumer Reports study released on Thursday which found a dozen different brands of soft drinks out of 81 tested contained 4-methylimidazole, some at higher-than-recommended levels (more than 29 micrograms per serving).

The highest levels, from samples purchased in California and New York, were found in regular Pepsi, Diet Pepsi, Pepsi One, Malta Goya and 365 Everyday Value Dr. Snap regular. The lowest were found in Diet Coke, Coke Zero and regular Coca-Cola. Sprite contained “no significant level” of the byproduct, Consumer Reports stated.

“These efforts will inform the FDA’s safety analysis and will help the agency determine what, if any, regulatory action needs to be taken,” said FDA spokeswoman Juli Putnam on Thursday.

However, during the agency’s assessment period and its ongoing review of available food safety information, FDA “is not recommending that consumers change their diets because of concerns about 4-MEI.”

Not all caramel coloring in foods contains 4-methylimidazole, also known as 4-MEI, only what FDA calls Class III and IV caramel coloring. Class I and II caramel coloring do not contain 4-MEI, and the current trend among some food and beverage manufacturers is to reduce 4-MEI levels or remove the substance entirely.

FDA requires that manufacturers of food products containing caramel coloring, such as colas, beers and a long list of other commercial foods and beverages, list its presence on the label either by name or as “artificial ingredients.” Caramel coloring is the single most widely used food coloring in the world, according to Consumer Reports.

In February 2011, the Center for Science in the Public Interest petitioned FDA to ban two types of caramel coloring used in food and beverage products, 2-methylimidazole and 4-MEI, stating that government studies showed they “caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats.”

California includes 4-MEI on its “list of chemicals known to the state to cause cancer.” While there is no official federal limit for levels of 4-MEI found in foods or beverages, in January 2012 California started requiring manufacturers to put a cancer warning label on any products sold in the state which would expose consumers to more than 29 micrograms of the substance per day. The California Office of Environmental Health Hazard Assessment has determined that amount poses a one in 100,000 risk of cancer to someone exposed daily to that level over a lifetime.

Consumer Reports suggested that FDA establish a maximum acceptable level of 4-MEI as an additive in foods and beverages, require labeling when it is present, and bar any products from being labeled as “natural” if caramel coloring is included.

“There is no reason why consumers need to be exposed to this avoidable and unnecessary risk that can stem from coloring food and beverages brown,” said Dr. Urvashi Rangan, a toxicologist and lead investigator on the study.

Representatives of the Grocery Manufacturers Association and the American Beverage Association have said there is no evidence that 4-MEI causes cancer or poses any other health risks to humans.

“First and foremost, consumers can rest assured that our industry’s beverages are safe,” the American Beverage Association said in a statement on Thursday. “Contrary to the conclusions of Consumer Reports, FDA has noted there is no reason at all for any health concerns, a position supported by regulatory agencies around the world.”

© Food Safety News
  • Marge Mullen

    I have trucker friends who haul for Pepsi and the barrels of this coloring have a skull and cross bones on them…nuf said.

  • CaptAegis

    Center for Science in the Public Interest is a wacko group which has no credibility scientifically. Their “studies” have been found to be lacking scientific rigor in their data, formulation and method. They should be trusted about as much as Bernie Madoff is currently trusted to do financial investment.

  • 48

    drinking an entire barrel of anything will probably kill you so let’s ban everything