PepsiCo Inc. is dismissing the results of a recent study conducted by Johns Hopkins researchers, which claimed that the levels of caramel coloring byproduct 4-MEI contained in some of the company’s products causes “avoidable and unnecessary” cancer risk concerns.
PepsiCo, stated that all of its U.S. products abides by the very stringent standards enforced by the state of California, and accuses the researchers of publishing outdated and unsubstantiated information.
The soft drink and snack food giant argues the U.S. Food and Drug Administration (FDA) maintains its position that there is no interim or urgent risks associated with the level of 4-MEI in food or beverages.
The study – “Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment,” was published on Feb. 18 in PLOS ONE, a UK–based scientific journal.
Keeve Nachman, the lead author is an assistant professor at John Hopkins Bloomberg School of Public Health. He and several colleagues, analyzed 4-MEI concentrations using samples from 11 different soft drinks – including several Pepsi products. The researchers assessed exposure to 4-MEI from caramel-colored soft drinks, then calculated the potential cancer risk.
The study found that 4-MEI concentrations observed in the beverage samples associated with average rates of soft drink consumption “pose excess cancer risks exceeding one case per 1,000,000 exposed individuals.”
Nachman characterized the excess cancer level as a common acceptable risk goal used by some federal regulatory agencies.
The study singled out Pepsi, Diet Pepsi and Pepsi One as the riskiest products analyzed by the researchers. This group of products “resulted in 4-MEI exposures with associated risks exceeding one excess cancer incidence in 10,000 exposures, suggesting that “the risk can greatly exceed this threshold,” the study concluded.
Responding to the figures, PepsiCo told the soft drink trade publication Beverage Daily “the study contains outdated information. The 4-MEI figures reported in this study do not reflect what is currently available in the U.S. Marketplace.”
4-MEI was listed as a carcinogen under California’s Proposition 65 in 2011. The law requires beverage companies to display warnings on its’ products if 4-MEI levels exceed the state’s Safe Harbor Level. The
Johns Hopkins study also found that several California beverages had lower levels of 4-MEI than in other states.
PepsiCo replied that: “Today all Pepsi products in the United States meet California’s Prop 65 requirements.”
The company added that the FDA has stated “there is no reason to believe that there is any immediatee or short-term danger presented by 4-MEI at the levels expected in food from the use of caramel coloring.”
The American Beverage Association (ABA), a national trade association representing beverage companies also contends that caramel coloring is safe.
Christopher Gindlesperger, senior director for public affairs for the organization noted “leading regulatory and public health organizations around the world have repeatedly confirmed its safety.”
Gindlesperger added that consumers would have to drink more than a thousand cans of soda in a day to match the doses used on lab animals in studies.
The ABA challenged the 2011 listing of 4-MEI by suing the California Office of Environmental Health Hazard Assessment (OEHHA), later dismissing the suit when it became evident it was a lost cause.
Last year both Pepsico and Malta Goya were named in Propositon 65 enforcement actions alleging the companies failed to warn consumers their products contain levels of 4-MEI exceeding the state’s Safe Harbor Level.
Despite of the various sources disputed by PepsiCo and others, Keeve Nachman, co-author of the John Hopkins study said “We stand by the results of our study.”