FDA 30-day notification date calculator

Verify before filing

This calculation does not determine whether a statement is a structure/function claim, whether notification is required, or whether a filing is timely. Review the FDA structure/function claims information and current submission instructions.

How the planning date is calculated

The tool adds 30 calendar days to the first U.S. marketing date you enter. For example, a first marketing date of October 1 produces October 31 as the planning date. It does not count from artwork approval, manufacture, shipment, or the date a seller first notices the requirement. Keep dated evidence supporting the actual first marketing event and the exact statement used at that time.

The statutory wording is “no later than 30 days after” first marketing with the statement. Confirm the responsible manufacturer, product identity, claim text, substantiation, and current submission method before relying on the displayed date. A calculation result is neither a filing receipt nor evidence that FDA accepted the statement.

Keep a complete notification record

• Final label or labeling with the claim and linked disclaimer.
• Evidence for the first marketing date.
• Copy of the submitted notification and delivery confirmation.
• Substantiation for the exact claim and conditions of use.
• Later changes, withdrawals, or corrected submissions.

See the FDA notification information and 21 U.S.C. 343(r)(6).