Dietary Supplement Reps Ask FDA For Clarity Across The Board On NDIs
This article was originally published in The Tan Sheet
Executive Summary
FDA should focus the 75-day premarket notification process specifically on ingredients, not finished products, industry stakeholders asserted at the agency's public meeting on new dietary ingredient (NDI) submissions Nov. 15
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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.