New dietary ingredient notification: buyer checklist
A new dietary ingredient notification is a premarket safety submission for certain dietary ingredients. Where required, the manufacturer or distributor must notify FDA at least 75 days before introducing the product into interstate commerce. Resolve applicability before promising a launch date.
Define the ingredient and intended use
Ask for the exact ingredient identity, manufacturing process, serving amount, conditions of use and evidence supporting its regulatory status. FDA’s guidance describes submission procedures and timeframes; use it with the underlying law when reviewing whether your specific ingredient requires notification.
Read the notification and FDA response
FDA publishes reviewed notifications with ingredient name, submitting firm, submission date and response date. Search that record and read the linked material. A matching name is a starting point, not proof that your supplier’s material, process or conditions of use match the submission.
Record the decision before production
Our procurement recommendation is to name the person responsible for the ingredient review, retain the evidence and record any assumptions about process and use. Ask what happens if the source or process changes. Keep the relevant FDA response with your supplier and formulation records.
Next steps
Sources
Sources checked . Company descriptions are their own statements; they are not certification verification.
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