CSPI Calls for Ban on Caramel Coloring

The CSPI notes that The National Toxicology Program, the division of the National Institute of Environmental Health Sciences that conducted the animal studies, said that there is “clear evidence” that both 2-MI and 4-MI are animal carcinogens.

17 Feb 2011 --- The “caramel coloring” used in Coca-Cola, Pepsi, and other foods is contaminated with two cancer-causing chemicals and should be banned, according to a regulatory petition filed by the Center for Science in the Public Interest (CSPI).

According to the CSPI, in contrast to the caramel one might make at home by melting sugar in a saucepan, the artificial brown coloring in colas and some other products is made by reacting sugars with ammonia and sulfites under high pressure and temperatures. Chemical reactions result in the formation of 2-methylimidazole and 4 methylimidazole, which in government-conducted studies caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats, the group claims.

The CSPI notes that The National Toxicology Program, the division of the National Institute of Environmental Health Sciences that conducted the animal studies, said that there is “clear evidence” that both 2-MI and 4-MI are animal carcinogens. Chemicals that cause cancer in animals are considered to pose cancer threats to humans. Researchers at the University of California, Davis, found significant levels of 4-MI in five brands of cola.

“Carcinogenic colorings have no place in the food supply, especially considering that their only function is a cosmetic one,” said CSPI executive director Michael F. Jacobson. “The FDA should act quickly to revoke its approval of caramel colorings made with ammonia.”

The International Food Information Council dismissed the claims around caramel coloring and 4-MEI. “Once again advocates are picking a chemical of the day to needlessly scare consumers. MEIs formed in caramel color have not been proven to cause adverse health effects. The primary studies linking MEIs to cancer showed varying effects in male and female mice and rats when each were tested at extremely high doses. In fact, further studies indicated that MEIs may offer a reduced risk of cancer. It is always important to look at new scientific research, but it also is important to put that research in the context of the totality of the science. In this case nothing approaches the need for a change in advice to consumers,” David Schmidt, President & CEO of IFIC stated.

According to the CSPI, federal regulations distinguish among four types of caramel coloring, two of which are produced with ammonia and two without it. CSPI wants the Food and Drug Administration to prohibit the two made with ammonia. The type used in colas and other dark soft drinks is known as Caramel IV, or ammonia sulfite process caramel. Caramel III, which is produced with ammonia but not sulfites, is sometimes used in beer, soy sauce, and other foods.

Five prominent experts on animal carcinogenesis, including several who have worked at the National Toxicology Program, joined CSPI in calling on the FDA to bar the use of caramel colorings made with an ammonia process. “The American public should not be exposed to any cancer risk whatsoever as a result of consuming such chemicals, especially when they serve a non-essential, cosmetic purpose,” the scientists wrote in a letter to FDA Commissioner Margaret Hamburg.

CSPI also says the phrase “caramel coloring” is misleading when used to describe colorings made with ammonia or sulfite. The terms “ammonia process caramel” or “ammonia sulfite process caramel” would be more accurate, and companies should not be allowed to label any products that contain such colorings as “natural,” according to the group.

“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.”

The American Beverage Association called the CSPI’s claims “scare tactics” and a “tall tale” and dismissed the calls.

In a statement, the Association said, “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.”

According to the ABA, 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."
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,” the ABA concluded.