4-MEI is not a threat to human health. There is no evidence that 4-MEI causes cancer in humans. No health regulatory agency around the globe, including the Food and Drug Administration, has said that 4-MEI is a human carcinogen.
In response to an announcement by the Center for Science in the Public Interest to petition the U.S. Food and Drug Administration to ban 4-methylimidazole, commonly known as 4-MEI and found in caramel coloring, the American Beverage Association released the following statement:
4-MEI is not a threat to human health. There is no evidence that 4-MEI causes cancer in humans. No health regulatory agency around the globe, including the Food and Drug Administration, has said that 4-MEI is a human carcinogen. This petition is nothing more than another attempt to scare consumers by an advocacy group long-dedicated to attacking the food and beverage industry.
4-MEI is virtually ubiquitous, found in trace amounts in a wide variety of foods and beverages. It forms during the heating, roasting or cooking process.
The very National Toxicology Program that CSPI cites actually undermines the group's reckless attack as the NTP does not identify 4-MEI as even "reasonably anticipated to be a human carcinogen."
(Source: Report on Carcinogens, Eleventh Edition. http://ntp.niehs.nih.gov/index.cfm?objectid=32BA9724-F1F6-975E-7FCE50709CB4C932)
In fact, a group of plaintiffs - the California League of Food Processors, the American Beverage Association, Grocery Manufacturers Association and the National Coffee Association - have filed a lawsuit against the California Office of Environmental Health Hazard Assessment for its wrongful listing of 4-MEI under Proposition 65. The state agency's decision does not reflect sound science and failed to follow its own regulations. Also, it did not take into account all the data available on the subject in this process.
In a letter to OEHHA opposing the listing of 4-MEI, Dr. Ernest E. McConnell, former Director of the National Toxicology Program's Toxicology Research and Testing Program, wrote: "NTP has not included 4-MEI on its list of chemicals causing cancer; i.e., the Report on Carcinogens." Dr. McConnell writes further that 4-MEI does not have sufficient evidence of carcinogenicity to be placed on that list. "NTP has not written a report which ‘concludes' that 4-MEI ‘causes cancer,' nor has NTP otherwise identified 4-MEI as ‘causing cancer' in the way that phrase is used by NTP and regulatory agencies with respect to the identification of chemicals as posing a carcinogenic hazard."
The bottom line is that this petition to the FDA by a group of activists is not based on sound science and is unnecessarily raising the fears of consumers.
The safety of our products is the foremost priority for our companies. Consumers can take confidence in the fact that people have been safely drinking colas for more than a century, as well as consuming the wide variety of foods and beverages containing 4-MEI, from baked goods and breads to molasses and coffee.
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The American Beverage Association is the trade association representing the broad spectrum of companies that manufacture and distribute non-alcoholic beverages in the United States.