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new dietary ingredient (NDI)


FDA’s Misguided NDI Amnesty Scheme—But Companies Should Still Comply with the Law

by Marc Ullman | August 1, 2022

On May 19, 2020, FDA (U.S. Food and Drug Administration) published a proposed Guidance Document announcing its intention to adopt a “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry” (The Draft Guidance). This document announced FDA’s intent to consider, pending public comment, a six ...

Great To Be GRAS

by Kate Quackenbush | December 1, 2011

With increased ingredient safety concerns and an exploding global functional food and beverage market, ingredient suppliers and experts talk about the importance and process of attaining GRAS status, and the role it could potentially play with NDIs.According to the U.S. Food and Drug Administration (FDA), under sections 201(s) and 409 of the Federal Food, Drug, ...

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