New Dietary Ingredient (NDI) Notification Process - fda.gov
FDA updated the New Dietary Ingredient (NDI) notification process, potentially requiring new submissions or revisions for supplements containing ingredients not marketed before October 15, 1994.
Aforeworn detected this change in the Dietary-Supplement Labeling (FDA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers should confirm how it applies to their specific situation before acting. There is a time constraint attached: Immediately; FDA may issue warning letters or initiate enforcement actions for non-compliant products.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Dietary-Supplement Labeling (FDA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA revised the NDI notification process, including new requirements for safety evidence and submission format.
Who it affects
Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers
What you must do
Review current NDI notifications for compliance with updated guidance; submit new or amended notifications for any NDI not previously notified.
Deadline
Immediately; FDA may issue warning letters or initiate enforcement actions for non-compliant products.
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