FDA Prior Notice is an advance electronic notification generally required for human and animal food imported or offered for import into the United States, unless an exemption applies. It allows FDA to review shipment and food-article information before arrival. FDA Registration Assistance prepares and submits Prior Notices on behalf of importers, exporters, manufacturers, brokers, and other knowledgeable parties.

FDA allows any individual with knowledge of the required information to submit Prior Notice, including manufacturers, exporters, brokers, importers, and U.S. agents. FDA Registration Assistance can prepare and transmit the filing based on the shipment and facility information you provide.

FDA must receive and confirm Prior Notice no less than 2 hours before arrival by road, 4 hours before arrival by rail, 4 hours before arrival by air, and 8 hours before arrival by water. For international mail, Prior Notice must be submitted before the food is sent. When filed through PNSI, a Prior Notice generally may not be submitted more than 15 calendar days before the anticipated arrival date.

Food imported or offered for import with inadequate Prior Notice is subject to refusal and, if refused, must be held at the port of arrival unless FDA or CBP directs otherwise. Delays can also create storage, demurrage, and logistics costs. FDA Registration Assistance reviews the information before filing to reduce avoidable submission errors.

Yes. Prior Notice generally applies to imported food for humans and other animals, including pet food, animal feed, ingredients, dietary supplements, beverages, and other FDA-regulated foods, unless an exemption applies. Certain meat, poultry, and egg products under USDA’s exclusive jurisdiction are among the exemptions.

Required information varies by entry type and transportation mode, but commonly includes submitter/transmitter details, the FDA product code and common or market name for each food article, quantity, manufacturer information, FDA country of production, shipper and importer details, and applicable carrier and arrival information. Grower information is required in certain cases for food in its natural state.

Yes. FDA Registration Assistance can review your shipment information, prepare the Prior Notice, transmit it electronically through FDA’s Prior Notice System Interface (PNSI), and provide the FDA confirmation details after successful submission.

Prior Notice is submitted for each article of food in an import entry. A single shipment containing multiple different food articles may therefore require multiple Prior Notices. FDA Registration Assistance can organize recurring and multi-product filings so the required food articles are properly covered.

The FDA Prior Notice System Interface (PNSI) is one of the electronic methods used to submit Prior Notice directly to FDA. Prior Notice can also be transmitted through CBP’s Automated Commercial Environment (ACE). FDA Registration Assistance uses PNSI for the filings we prepare for clients.

FDA Registration Assistance charges $35 per Prior Notice filing. The fee covers preparation, review, electronic PNSI submission, and delivery of the FDA confirmation details. Because FDA requires Prior Notice for each food article, a shipment containing multiple different food articles may require multiple filings. Contact us for recurring or high-volume filing needs.

Yes. Food arriving by international mail is generally subject to Prior Notice unless an exemption applies, and the filing must be submitted before the food is sent. Beginning October 1, 2026, FDA will also require the name of the mail service and the mail tracking number in Prior Notice for food arriving by international mail.

Once FDA has confirmed a Prior Notice, the confirmed information generally cannot be amended. If information that requires a new Prior Notice changes, a new Prior Notice must be submitted; FDA suggests cancelling the previous Prior Notice before submitting the replacement. FDA Registration Assistance can help review the change and prepare the replacement filing.

We recommend contacting FDA Registration Assistance as early as possible — ideally 24 to 48 hours before the required filing deadline. This gives our team time to thoroughly review your shipment details, resolve any discrepancies, and file well within FDA timeframes, eliminating any last-minute risk.

Prior Notice requirements are not based simply on shipment size or value. FDA regulations contain specific exemptions, including certain food personally carried for personal use, certain homemade personal gifts, food exported without leaving the port, specified USDA-regulated products, and diplomatic bags. Commercial samples and market-research samples generally require Prior Notice unless another exemption applies.

After FDA receives a facially complete Prior Notice, it issues a confirmation number. That confirmation does not mean FDA has approved the shipment or determined that no further FDA action will occur. FDA recommends confirmation accompany imported food shipments; specific confirmation-document requirements apply to PNSI-filed commercial shipments, international mail, and food carried by an individual.

Absolutely. FDA Registration Assistance specializes in managing Prior Notice filings for importers with frequent or high-volume shipments. We streamline the process by maintaining your product and facility data on file, enabling fast, accurate submissions for every shipment — reducing your administrative burden and keeping your supply chain moving without interruption.

FDA regulations provide specific exemptions, including food carried by an individual for that individual’s personal use, food made in a personal residence and sent by that individual as a personal gift, food exported without leaving the port of arrival, certain meat, poultry and egg products under USDA’s exclusive jurisdiction, and food in diplomatic bags. Commercial food samples, trade samples, and market-research samples generally require Prior Notice unless another exemption applies.

Except for international mail, FDA guidance states that Prior Notice generally may be submitted no more than 15 calendar days before anticipated arrival when filed through PNSI, or no more than 30 calendar days before anticipated arrival when transmitted through CBP’s electronic interface. The minimum advance time still depends on the mode of transportation.

No. Prior Notice is a shipment-level import notification requirement for each food article. Foreign Food Facility Registration applies to qualifying facilities that manufacture, process, pack, or hold food for U.S. consumption, while FSVP places supplier-verification responsibilities on the applicable U.S. FSVP importer. A single food import may involve all three requirements.

Under FDA’s 2025 final rule, when food is refused for inadequate Prior Notice, a required Prior Notice submission or resubmission generally must be made within 10 calendar days from the refusal notice, or within 10 calendar days from FDA’s response to a qualifying review request. If the required submission is not made in time, the food may be handled under CBP rules for general order merchandise.