Vitafoods: Hot Topic 3

New Dietary Ingredients: EU versus U.S. Approaches

New dietary ingredients (NDIs) take different approval routes in the EU versus in the United States. On May 7 at Vitafoods Europe, Tennille Marx, ND, senior research associate for natural products consulting firm AIBMR Life Sciences Inc. (Puyallup, WA), will discuss the differences. She’ll also provide insight to non-U.S. companies looking to enter the U.S. dietary ingredient market on how to navigate the U.S. FDA’s regulatory channel for NDIs.

“The authorization process for novel ingredients/foods in the EU has been known to take 35 months on average-and sometimes up to 60 months-whereas the U.S. FDA typically responds in 180 days for GRAS ingredients (novel ingredients) and in 75 days for new dietary ingredients intended for supplements-a major benefit of the U.S. market,” Marx says.

Marx will also focus in on the differences between FDA’s GRAS and NDI regulatory routes, as well as other factors that could dictate the direction of a company’s strategy in the United States, including the FDA’s recently released beverages-versus-supplements draft guidance.

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