Californian federal court dismisses 4-MEI medical monitoring lawsuit targeting PepsiCo

By Rachel Arthur contact

- Last updated on GMT

Californian federal court dismisses 4-MEI medical monitoring lawsuit targeting PepsiCo

Related tags: Diet pepsi, Cola, Soft drink, Pleading, Pepsi

A Californian federal court has dismissed a lawsuit that argued consumers of Diet Pepsi and Pepsi One should be entitled to medical monitoring due to the alleged health risk posed by caramel coloring byproduct 4-MEI. 

Plaintiffs Riva and Ardagna had alleged that consuming Pepsi One and Diet Pepsi created an increased health risk, warranting cancer screenings and ongoing medical monitoring for all Californians who had consumed the drinks.

They claimed consumers faced an increased risk of contracting bronchioloalveolar cancer, from what they described as ‘unacceptable’ levels of 4-MEI.

Rat studies criticized, no 'credible' cancer risk established

Riva and Ardagna had initially been part of a consolidated class action against PepsiCo, claiming the levels of organic chemical compound 4-Methylimidazole (4-MEI) in Pepsi products were unhealthy. The Riva action was severed to pursue medical monitoring and personal injury claims, and proceeded on its own.

On Wednesday, US District Judge Edward Chen in the Northern District of California dismissed the case.

The court said the plaintiffs, “have not established that the alleged risk of bronchioloalveolar cancer (for which they seek lung scans and testing) is both credible and substantial.”

Pepsi drinks are among soft drinks and foods which use caramel coloring byproduct 4-MEI, which has been linked to carcinogenic activity in mice.  

As part of Pepsi’s motion to dismiss the action, attorneys argued in December the plaintiffs had not asserted a plausible claim for medical monitoring.

They said the plaintiffs relied on studies of rodent exposure, arguing this did "not come anywhere near replicating human consumption patterns,"​ and added the lawsuit could not meet the requirement of pleading actual injury or harm.

'4-MEI risk? You'd have to drink 1000+ cans of soda a day' - PepsiCo attorneys

PepsiCo’s attorneys also referenced the FDA’s position, that a human being would have to consume "more than a thousand cans of soda in a day"​ to reach significant 4-MEI (4-methyl-imidazole) intake. They also pointed out that 4-MEI is included in other foodstuffs – such as coffee, grilled meat, beer and dressings – and so consumption could not be directly traced to Pepsi One or Diet Pepsi specifically.

4-MEI was added to California’s Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) list of carcinogens in 2011. Pepsi states the 4-MEI levels in Pepsi One and Diet Pepsi fall within the limits set by Proposition 65.

In late February PepsiCo hit back at a cancer risk study​ that appeared in the open access journal PLUS One​, which linked caramel coloring byproduct 4-MEI to ‘avoidable and unnecessary’ cancer risk.

PepsiCo - which was named in the study for comparatively high levels of 4-MEI - says all its US products meet stricter Californian standards, accusing the study of containing outdated information.

However, responding to similar comments from Goya Foods, which was also named in the study, its senior author Keeve Nachman, from John Hopkins Bloomberg School of Public Health, told this website: "We stand by the results of our study."

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