If a package with food or certain cosmetics arrives in the U.S., the FDA needs to know about it before it gets there. This is called a Prior Notice. If the notice is missing or wrong, the package can be stopped, delayed, or sent back — and that costs money and time.
The rules are different for:
Food (all human and animal food). Prior Notice is always required.
Cosmetics — most cosmetics are not “food,” but some products may be considered drugs (for example, an acne product making medical claims) or contain ingredients that make them regulated like drugs or food. Those products may need additional steps. (U.S. Food and Drug Administration)
Use the FDA’s Prior Notice System Interface (PNSI) at access.fda.gov to submit a prior notice. (U.S. Food and Drug Administration)
You can file a prior notice up to 15 calendar days before arrival via PNSI (some other channels allow up to 30 days). Time windows and deadlines change by transport mode. (Registrar Corp)
New rules require mail shipments to include the mail carrier name and tracking number in prior notice submissions. (U.S. Food and Drug Administration)
Missing or late prior notice can cause a hold, refusal, or return of the shipment. (U.S. Food and Drug Administration)
Importers bringing products that might be food-like (e.g., edible cosmetics, ingestible beauty supplements) or cosmetics that make drug claims from other countries into the United States
Exporters and sellers sending products that might be food-like (e.g., edible cosmetics, ingestible beauty supplements) or cosmetics that make drug claims from Nigeria (or anywhere) to the U.S.
Any other submitter on behalf of the importer or shipper.
Have this ready before you start:
Your company name and contact details (shipper/exporter)
Receiver’s name and U.S. address (consignee/ultimate consignee)
Shipment arrival date and port or mail service info
Description of each product (clear short name, e.g., “dried chili powder”)
Quantity, weight, and packaging type
Country of origin and manufacturer name/address
Invoice or value information
Carrier name and tracking number (especially for express shipping). (U.S. Food and Drug Administration)
Open a web browser and go to https://access.fda.gov/.
Sign up or sign in. (If an organization files often, the company can create and manage user accounts.) (U.S. Food and Drug Administration)
After login, find “Prior Notice” or PNSI and click to open it.
Choose Create New Prior Notice (or similar button). The PNSI user guide walks through the screens step-by-step. (U.S. Food and Drug Administration)
The forms ask for boxes like:
Submitter/Preparer: Who is filing the notice.
Shipper: Company/Sender/Individual sending the goods.
Consignee/Ultimate Consignee: Who will receive it in the U.S. (full address).
Manufacturer: Where it was made.
Arrival Information: Port of entry, mode (air, sea, land), expected arrival date/time.
Carrier info: Carrier Name, Airline name, vessel, truck company, or mail carrier + tracking number (mail shipments). (U.S. Food and Drug Administration)
For each item, enter a clear description: what it is, how many, weight, packaging (e.g., 10 boxes of ... × 500g each).
Avoid vague terms like “gift” or “merchandise.” Use plain labels: “dried cassava flour,” “bottled body lotion 250ml.”
If the product is a cosmetic that could be a drug (e.g., “acne treatment cream”), note that and include ingredient info or product claims, because extra rules may apply. (U.S. Food and Drug Administration)
When all fields are complete, click Submit.
The system will give a Prior Notice number and a confirmation. Save that number and the confirmation email or screenshot. This proves the FDA was notified. (U.S. Food and Drug Administration)
Give the Prior Notice number to the carrier and Routely Customer Support Team
For mail shipments, include the mail tracking number in the prior notice and on documents. This is now required. (U.S. Food and Drug Administration)
PNSI: Submit no earlier than 15 days before arrival and no later than the short-notice windows (these windows change by transport mode — air, sea, land, or mail). Check the PNSI user guide for exact mode deadlines. (U.S. Food and Drug Administration)
ACE/CBP or other electronic filings: Some systems allow up to 30 days before arrival. If using an importing broker or automated systems, follow those timelines. (U.S. Food and Drug Administration)
Whenever it is requested for clearance (whether it was not created before or it expired)
Cosmetics are normally not food and do not need Prior Notice as food. But if a cosmetic is intended to be ingested or makes drug claims (treats disease), it may be regulated as a drug or food and may need extra permits, registration, or different filing. Always check product classification. (U.S. Food and Drug Administration)
Recent laws (MoCRA) expanded FDA cosmetics authority — some cosmetics now need registration and reporting. If importing cosmetics, ensure compliance under the current rules. (U.S. Food and Drug Administration)
The FDA or Customs can hold, refuse, or return the shipment. This causes delays and extra costs. (U.S. Food and Drug Administration)
FDA Prior Notice page (how to file and rules). (U.S. Food and Drug Administration)
FDA PNSI User Guide (step-by-step PNSI instructions). (U.S. Food and Drug Administration)
FDA’s guide on imported cosmetics and product classification. (U.S. Food and Drug Administration)
FDA rule updates on prior notice and mail tracking requirements. (U.S. Food and Drug Administration)
Q: Do I always need to file Prior Notice?
A: If the shipment contains food (human or animal), yes. For cosmetics, check whether the product is treated as a food or drug. If unsure, ask us or check FDA guidance as linked in the article above.