FDA Prior Notice is the formal food-import notification system administered by the Food and Drug Administration under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act"). The requirement is codified at 21 CFR Part 1, Subpart I, and applies to virtually all food imported, offered for import, or transshipped through the United States.
For the underlying mechanics and timing rules, see Prior Notice. This entry focuses on scope, exclusions, and compliance interaction with CBP.
Scope — food subject to Prior Notice:
- Food for humans (raw agricultural products, processed foods, beverages, dietary supplements)
- Food for animals (pet food, animal feed)
- Food contact substances (food packaging in some cases)
- Bottled water, ice
- Live food animals (e.g., live fish for human consumption)
Excluded from Prior Notice:
- Food carried by an individual for personal use
- Food made by an individual in their personal residence and sent by that individual as a non-business gift
- Food imported and exported without leaving the port (in-transit)
- Meat, poultry, and egg products under exclusive USDA jurisdiction (these have separate notice requirements)
Interaction with CBP entry process:
- Prior Notice confirmation number is filed with the entry summary data through ACE
- Food without a valid PN confirmation will not be released by CBP
- Repeated PN failures are an FDA enforcement priority and can trigger DWPE (Detention Without Physical Examination) Import Alerts
Recordkeeping: Importers must maintain Prior Notice records for two years and produce them on demand. Failure to maintain records can trigger penalties under Section 1592 (CBP) and 21 U.S.C. § 333 (FDA).
Food importers should treat Prior Notice as a core element of their reasonable care compliance program, with documented procedures and personnel training.