Plan the 30-day notification without treating it as approval

Start with the triggering facts

1. Identify the exact statement: preserve the claim wording and every linked qualifier.
2. Classify the statement: determine whether it is a covered dietary supplement statement rather than assuming every marketing sentence uses the same route.
3. Establish first marketing: record when the product was first marketed with that statement and retain the evidence used for the date.
4. Identify the responsible manufacturer: confirm the party that must submit and the information required in the notification.
5. Review the filing method: follow current FDA submission instructions and retain the submission record.

What the 30-day period means

The statutory language is “no later than 30 days after” first marketing with the statement. It is not a general thirty-day premarket waiting period. A calendar calculation also does not decide whether the statement qualifies, whether the submitted record is complete, or how FDA will view the claim.

Records to keep together

• Final label or labeling showing the complete statement and disclaimer relationship.
• First-marketing date and the evidence supporting that date.
• Product and manufacturer identity used in the submission.
• Substantiation file for the statement.
• Submission copy, confirmation, later amendments, and claim withdrawal history.

Official starting points

• FDA — Structure/Function Claims
• FDA notification information
• 21 U.S.C. 343(r)(6)

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