FDA NDI Notification Draft Guidance Contradicts Final Rule – Ullman
This article was originally published in The Tan Sheet
Executive Summary
FDA contradicts its final rule on new dietary ingredient notifications with its draft guidance requiring notifications for all supplements containing an NDI, food and drug attorney Marc Ullman contends.
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Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft
FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance.
Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft
FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance.
Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft
FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance.