Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues - fda.gov
FDA released draft guidance on New Dietary Ingredient (NDI) notifications, clarifying requirements for when an NDI notification is needed and what information must be included. This impacts supplement brands, contract manufacturers, private-label sellers, and ingredient suppliers.
Aforeworn detected this change in the Dietary-Supplement Labeling (FDA) space on July 15, 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: Comment period ends 75 days after publication in Federal Register. Compliance expected upon finalization.. 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FDA issued draft guidance clarifying NDI notification requirements, including when a notification is required, what data to submit, and how to handle ingredients marketed before 1994.
Who it affects
Supplement brands, contract manufacturers, private-label sellers, ingredient suppliers
What you must do
Review the draft guidance and assess whether your products contain new dietary ingredients that require an NDI notification. Prepare to submit notifications or adjust formulations to comply.
Deadline
Comment period ends 75 days after publication in Federal Register. Compliance expected upon finalization.
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