"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. 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."
Leading public health organizations have reaffirmed that caramel coloring, including the trace amounts of 4-MEI found in it, is safe for use in colas and countless other foods.
In March 2011, following a comprehensive review of the scientific literature, the European Food Safety Authority (EFSA) reaffirmed the safety of 4-MEI and stated that the presence of 4-MEI in caramel coloring is not a health concern.
In November 2011, Health Canada said that 4-MEI, including that found in certain caramel colors, does "not represent a risk" to consumers.
The U.S. Food and Drug Administration has approved caramel as a color additive and lists it as a "generally recognized as safe" food ingredient.
A National Toxicology Program (NTP) study does not even list 4-MEI as "reasonably anticipated to be a human carcinogen" in its Report on Carcinogens (Source: Report on Carcinogens, Twelfth Edition. http://1.usa.gov/iId3qz)
California added 4-MEI to its list of carcinogens with no studies showing it causes cancer in humans. California's listing was based on a single study in lab mice and rats. A person would need to drink more than 2,900 cans of cola every day for 70 years to reach the lowest dose levels mice received in the single study upon which California based its decision. And, the study showed a reduction of tumors in the lab rats tested.
4-MEI forms in foods, such as caramel, during the heating, roasting and cooking process and is virtually ubiquitous – found in trace amounts in foods and beverages that have been commonly consumed for decades, including baked goods, coffee, breads, molasses, soy sauce, gravies and some beers.
From the March 7, 2012, Prepared Foods' Daily News.