Consumer Reports Investigates Use of Caramel Color

It had been a curiously long time (about one week), since any major players had taken a shot at the carbonated soft drink industry. The lawyers, we’d surmise, felt a bit lonely. Thanks to the Consumers’ Union, the publisher of Consumer Reports (CR), order has been restored.

The independent product-testing organization found that 12 brands of CSDs manufactured by The Coca-Cola, Co., Inc., PepsiCo, Inc. and Goya contain varying levels of 4-methylimidazole (4-MeI), a potentially-carcinogenic chemical byproduct of the production of certain types of caramel color as an ingredient, according to a CR release.

“We are concerned about both the levels of 4-MeI we found in many of the soft drinks tested and the variations observed among brands, especially given the widespread consumption of these types of beverages,” Dr. Urvashi Rangan, a toxicologist and executive director of the CR Food Safety and Sustainability Center, said in the release. “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.”

The American Beverage Association (ABA), the trade association representing non-alcoholic beverages in the U.S., responded in a release by assuring consumers that the industry’s beverages are safe — a claim backed by the U.S. Food and Drug Administration.

“A consumer ‘would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents,’” the ABA release said.

CR notes that caramel color is a coloring agent and shouldn’t be confused with caramel. The International Agency for Research on Cancer has recognized that some types of caramel color contain 4-MeI, according to the release.

California’s Proposition 65 states that any products that would expose consumers to more than 29 micrograms of 4-MeI in a day should carry a warning label, according to the state’s Office of Environmental Health Hazard Assessment. CR tested 81 cans and bottles from a variety of well-known brands between April and September 2013, and an additional 29 products in December 2013.

The testing found that 12 oz. single servings of Pepsi One and Malta Goya, both of which were purchased multiple times during the testing period, contained more than 29 micrograms per can or bottle. CR notes that while it cannot say if this violates Prop 65, it does believe that the levels are too high, so it’s asked Kamala D. Harris, the state’s Attorney General, to investigate.

According to the release, PepsiCo responded to CR by stating that Prop 65 is based on per-day exposure and not per-can exposure. The company also cited government consumption data indicating that diet soda consumers average 100 milliliters consumed per day, or fewer than one-third of a 12 oz. can. This, the company argues, prevents the need for a warning label, even with the amount of 4-MeI in the product. CR notes that it’s familiar with data indicating higher levels of daily CSD consumption.

CR said in the release that Coke products had the lowest levels of 4-MeI (an average of 4.3 micrograms per serving) of all the products tested.

“While our study is not big enough to recommend one brand over another,” Rangan said in the release, “our results underscore two key points: the first is that it is indeed feasible to get down to lower and almost negligible levels of 4-MeI. And the second is that federal standards are required to compel manufacturers to minimize the creation of this potential carcinogen.”

The full release of the ABA’s response follows:

“First and foremost, consumers can rest assured that our industry’s beverages are safe. 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.  In fact, FDA has noted that a consumer ‘would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents.’ However, the companies that make caramel coloring for our members’ soft drinks are now producing it to contain less 4-MEI, and nationwide use of this new caramel coloring is underway.”

Additional Background:

  • 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.

  • The U.S. Food and Drug Administration has stated, “A consumer would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents.”

  • In March 2011, following a comprehensive review of the scientific literature, the European Food Safety Authority (EFSA) reaffirmed 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.

  • California added 4-MEI to its list of carcinogens with no studies showing that it causes cancer in humans. California’s listing was based on a 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.

About The American Beverage Association

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.  For more information on ABA, please visit the association’s Web site at or call the ABA communications team at (202) 463-6770.