FDA Sees No Danger From Soda Chemical

The U.S. Food and Drug Administration (FDA) says it sees no danger from a soda chemical that has at least one advocacy group concerned.

After reviewing a complaint from The Center for Science in the Public Interest (CSPI) in which it said that a chemical, 4-methylimidazole, used in cola sodas causes tumors in animals, the FDA said there is no immediate risk, wrote Bloomberg News.

The U.S. regulator alleged that one would have to drink in excess of 1,000 cans of soda daily to match doses administered in studies that revealed links to the chemical, also known as 4-MEI—to cancer in rodents, said Douglas Karas, an FDA spokesman, wrote Bloomberg.

The CSPI disagrees, saying that high 4-MEI levels were detected in a number of drinks made by both the Coca-Cola Co. and the PepsiCo. Inc., wrote Bloomberg. 4-MEI is a component of coloring used in colas and is the subject of a just-released CSPI study.

“This is nothing more than scare tactics,” the American Beverage Association said, calling the claims “outrageous.” Meanwhile, the agency said it has no reason to believe consumers are in any danger, according to Karas, who said the CSPI’s petition is under review by the FDA, wrote Bloomberg.
The CSPI said it commissioned laboratory studies of a number of products—Coca-Cola, Pepsi-Cola, Diet Coke, Diet Pepsi, Snapple Group Inc.’s Dr Pepper and Diet Dr Pepper, and Whole Foods’ 365 Cola—from Washington DC-area locations, said Bloomberg. “Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer,” said Michael F. Jacobson, CSPI’s executive director. “The FDA needs to protect consumers from this risk,” Jacobson added, said Bloomberg.

According to the CSPI, Pepsi’s products, Diet Coke, and regular Coca-Cola all tested with levels significant enough to warrant a warning notice in California, wrote Bloomberg. As a matter-of-fact, 4-MEI was also entered on California’s list of carcinogens, even though no studies exist indicating it is carcinogenic in humans, the CSPI noted.

This is not the first time food dyes have been linked to adverse health effects. Last year, we wrote that after ignoring the issue of artificial food dyes and potential links to adverse health effects for nearly two decades, the FDA finally had an advisory panel look at potential links between chemical colorings and hyperactivity in children. Sadly, but not unexpectedly, the panel backed the dyes and rejected consumer advocate recommendations to issue warning labels or bans on the products many see as contributing to hyperactivity.

The FDA has long maintained that artificial food dyes are safe but, as far back as the 1970s, some pediatricians and other children’s advocates have called for the elimination of dyes and preservatives in the diets of children with behavior problems.

In 2007, a study commissioned by the UK Food Standards Agency linked hyperactivity in children to artificial colorings, some not used in the U.S., and one food preservative. In the European Union, foods containing artificial food dyes have been required to carry warnings that they may have an adverse effect on activity and attention in children since 2008. The European Union (EU) is an agency similar in construct and purpose to the FDA. The same year the EU mandated the warning, CPSI urged the FDA to ban eight dyes: FD&C Blue 1 and 2; FD&C Green 3, Orange B, FD&C Red 3, FD&C Red 40, FD&C Yellow 5 and 6, citing studies linking the dyes to behavioral effects mimicking hyperactivity in children.

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