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FDA

Pepsi, Goya Findings Put 4-MEI on FDA Regulatory Agenda

FDAConsumer Reports’ findings on 4-methylimidazole in Pepsi and Goya Foods products, among others, has sparked lawsuits and a renewed FDA investigation of the chemical’s safety.

The magazine found that single servings of Pepsi One and Malta Goya exceeded the 29 micrograms level that is the threshold in California, without carrying the warning required under the state’s Proposition 65, Food Processing reports.

The FDA said it is reviewing all available data on the safety of 4-MEI and is reassessing potential consumer exposure to 4-MEI from the use of Class III and Class IV caramel coloring in food products. It is also conducting new studies of 4-MEI safety, the AP reports.

Future regulatory action could include setting a limit on 4-MEI amounts in caramel coloring, the FDA says.

4-methylimidazole is a chemical compound that is not directly added to food, but is formed as a byproduct during the manufacturing of certain types of caramel coloring, the FDA says. The chemical may also form when coffee beans are roasted and when meats are roasted or grilled.

Prop. 65 classifies 4-MEI as a carcinogen, even though studies on the chemical’s cancer-causing properties have been inconclusive, the AP reports.

The Consumer Reports finding has also caused at least two suits to be filed in California federal court, accusing the companies of false advertising and deceptive business practices, and more could follow, Emord & Associates PC principal Peter Arhangelsky told Law360.

As for the FDA review, Arhangelsky said, “If they say they’re going to revisit this, you’re going see something come of it.”

Takeaway: The FDA is renewing investigations into the safety of 4-methylimidazole, and says it will consider new regulations, in the wake of Consumer Reports’ findings that the chemical exceed Prop. 65-approved levels in Pepsi and Goya products.

Tamar Wilner is Senior Editor at Environmental Leader PRO.

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