FDA Prior Notice — required? when? what fields?

Answer 8 questions about your US food, feed, supplement, or beverage shipment and get a legal verdict, the exact lead-time deadline by transport mode, the required data fields, and the matching 21 CFR citations.

21 CFR Part 1 Subpart I rules effective 2013-05-30 · operator-verified 2026-06-09.

Shipment parameters

Verdict and deadlines

Rules effective 2013-05-30 · verified 2026-06-09 · dataset 2026.06.09

Determination

Prior Notice IS required

Minimum lead time
8 h

21 CFR 1.279(a)

Must be confirmed by (legal deadline)
2026-07-15 06:00

arrival − 8 h, in America/Los_Angeles

Submit by (with buffer)
2026-07-15 05:30

legal deadline − 30 min buffer

Earliest submission (30-day window)
2026-06-15

CBP ACE Cargo Release window

On track — submit before the deadlines shown.

Required data fields (17)

  • submitter info
  • transmitter info
  • entry type
  • fda product code
  • common name
  • manufacturer registration number or exemption
  • grower full address
  • shipper
  • owner
  • ultimate consignee
  • carrier
  • mode of transport
  • anticipated arrival port
  • anticipated arrival datetime
  • bill of lading or awb master number
  • country of production
  • country from which shipped

Applicable citations

  • 21 CFR 1.279 (timing)
  • 21 CFR 1.281 (required information)

Sources

  • 21 CFR 1.279 — Timing of Prior Notice submissions (lead-time hours by transport mode).
  • 21 CFR 1.281 — Required information for a Prior Notice submission.
  • 21 CFR 1.277(b) — Exemptions: USDA-exclusive, personal-use accompanied, diplomatic bag.
  • Bioterrorism Act 2002 §307 — Statutory authority for Prior Notice (21 U.S.C. 381(m)).
  • FSMA 2011 IFR (effective 2013-05-30) — Refused-country field requirement and additional data elements.
  • FDA Prior Notice Compliance Policy Guide — Operational guidance for ABI/ACE vs PNSI filing channels.

Disclaimer

Results are orientative. They do not constitute legal advice and do not substitute for a licensed customs broker, FDA-compliance consultant, or counsel. Consult a qualified professional before submitting a Prior Notice.