After the Center for Science in the Public Interest (CSPI) informed Food and
Drug Administration (FDA) Commissioner Margaret Hamburg that laboratory
analyses of soft drinks revealed high levels of 4-methylimidazole (4-MEI)
in certain caramel colored beverages, the major soft drink manufacturers
reported that they were changing the way they manufacture the caramel
coloring to address the issue. California added 4-MEI to its list of chemicals
known to the state to cause cancer (Prop. 65), and the companies had already
apparently reformulated products sold there to avoid the need for a Prop. 65
cancer exposure warning.

The changes will be expanded throughout the national market even though
an FDA spokesperson reportedly indicated in response to CSPI’s claims that a
person would have drink in excess of 1,000 cans of soda a day to achieve the
levels to which rats were exposed in studies purportedly showing an association
with cancer. The American Beverage Association reportedly called CSPI’s
claims “outrageous” and little more “than scare tactics.” FDA is apparently
reviewing CSPI’s 2011 petition seeking to revoke the generally recognized
as safe designation for these chemicals and to prohibit products containing
them from being labeled “natural.” CSPI’s March 5, 2012, letter to the FDA commissioner was an amendment to that petition and complained about FDA’s lack of action, while attempting to “clarify the risk posed by caramel colorings in soft drinks.” See CSPI, American Beverage Association press releases and Reuters, March 5, 2012; Associated Press, March 8, 2012.

About The Author


For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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