Report of Potential Carcinogen in Soda Coloring Paves Way for High Stakes Prop. 65 Suits


Plaintiffs’ law firms are seeing green in the caramel coloring added to brand-name soft drinks.  A recent Consumer Reports investigation found elevated levels of a potential carcinogen in beverages produced by two global manufacturers.  Less than 10 days later, one of those manufacturers has already received a notice of intent to sue under California Proposition 65 (Prop. 65).


Consumer Reports tested 110 cans and bottles of soda from five manufacturers for a chemical called 4-methylimidazole (4-MEI).  The substance is not an additive itself, but an impurity generated during the manufacture of caramel colors, known as III and IV.  Of the beverages tested, two, Malta Goya and Pepsi One, were repeatedly found to contain more than 29 micrograms of 4-MEI per 12-ounce serving (the current maximum amount a product may contain on the California list of chemicals without a Prop. 65 warning).


California listed 4-MEI as a potential carcinogen two years ago, based on a study on mice conducted by the International Agency for Research on Cancer in 2007.  On the same day Consumer Reports released its findings, the U.S. Food and Drug Administration (FDA) confirmed it is testing foods and beverages for 4-MEI.  For the time being, the FDA maintains its position that 4-MEI levels in food from caramel coloring do not pose a risk to consumers.


Goya Foods Inc. has already received a 60-day notice of Prop. 65 violation for failure to provide a warning of 4-MEI in its beverages.  The notice cites other product exemplars that Consumer Reports did not appear to test, Goya Sangria and Goya Ginger Beer.  Testing showed that Goya Malta had the highest concentration of 4-MEI, with four samples from across the country registering more than 300 micrograms of 4-MEI per 12-ounce serving.


As of the date of this publication, PepsiCo Inc. has not been noticed.  Testing showed Pepsi One samples from New York contained high levels of 4-MEI, but samples from California did not.  PepsiCo told Consumer Reports the company changed manufacturing processes to meet California’s Prop. 65 requirements as soon as the regulations went into effect, and is also reformulating its beverages again to contain lower levels of 4-MEI.  The reformulated products are set to be available across the United States this month.


Both Goya Foods and Pepsico were named in proposed class actions in federal court alleging deceptive practices in concealing 4-MEI content and health risks to consumers.  This strategy highlights the unique nature of Prop. 65 and the favorable jurisdiction in California federal courts to food labeling litigation.  Often, both venues – Prop. 65 notices and class action litigation – can go after the same chemical and product and present companies with double the headache.


What does this mean for food and beverage makers? If your product includes a carbonated beverages or a food coloring, and if the label includes the ingredient “caramel color” or “artificial color,” you are likely on the radar of plaintiff and consumer groups.  Beverage industry suppliers should consider immediately testing products for 4-MEI and reformulate if test indicate amounts close to 29 micrograms per 12-ounce serving.  Thought should also be given to vendor contracts being beefed up to contain language requiring vendors to certify that their products contain no 4-MEI, or otherwise contain no more than an amount of 4-MEI that would require the manufacturer to provide a Prop. 65 warning.

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