Food into the US: who files FDA Prior Notice, which portal, which arrival clock

Tuesday afternoon, the US buyer’s forwarder drops a line: “FDA prior notice due before arrival. Send the confirmation number today or CBP holds the food.” The box is a full container of sauce from Yantian. The contract seller is a Hong Kong company; the kitchen is in Chaozhou. Sales zips last week’s food-facility registration PDF, an Alibaba.com showcase screenshot and the sentence “we have FDA,” and replies that the certificate is filed and the cargo will hit Los Angeles on Friday.

Wednesday, the broker writes back: that paper is facility registration, not Prior Notice for this booking. The registration number will not fill the confirmation box. The forwarder then wants the Alibaba.com master login “so we can fix FDA in the system,” plus a power of attorney with no booking number. No one has yet said whether this booking is FDA food. The floor is already rostered to stuff on Thursday night. Finance asks whether an “official FDA fine” should be locked into the unit price.

Thursday the box leaves the plant. Friday the ship’s agent says the vessel is due in Los Angeles next Wednesday. Sales forwards last week’s lamp-container ISF ten-element sheet with a new title, assuming “the US 24-hour rule” will cover it. The broker replies: ISF faces foreign-port loading; Prior Notice faces arrival. On a vessel booking the floor is no less than 8 hours before arrival at the port of arrival, and FDA must confirm. A WeChat “we filed” is not a confirmation number.

Do not reply that you “have a clearance channel” and that FDA is “in the freight.” Stop three things the same day: do not hand over the master login, do not rename the registration PDF as a confirmation number, and do not tick a warehouse date in trade assurance while the confirmation box is empty. The order below is the one a sales desk can use: decide whether this booking is FDA food, name who may file, name the arrival clock, pick this week’s portal, keep the two numbers in different boxes, then deal with cargo that is already in with no confirmation. Who stands as importer at entry is on the forwarder cannot take IOR. If the sample goes by air and the bulk by ocean, see air samples and ocean bulk. Changing the path does not erase this box.

First decide whether this booking is FDA “food”: people, pets, samples, transit

FDA writes Prior Notice for food imported or offered for import into the United States. In that official sentence, food includes food for humans and food for animals. Chaozhou sauce, Dongguan candy, Qingdao freeze-dried pet treats — if the booking is entering the US or is offered for import, ask it as food. Do not drop the box because your floor calls the line a snack, a gift or feed.

The FDA industry guidance and the filing page pin the scope to “imported or offered for import.” Samples, show tastings and quality holds stay inside that sentence when they are imported or offered for import. Do not announce in the group that Prior Notice is waived because the invoice says sample, FOC or no commercial value. Three cartons by air and a full container by ocean are two fulfilment paths — see air samples, ocean bulk. You may split the path. You still ask this box on each booking.

Cargo that transits the United States on the way to Canada, Mexico or another third country should not be self-exempted in WeChat. The official sentence is imported or offered for import. If the goods change boxes in Los Angeles or are stripped in Chicago and sent on, ask this booking’s broker in writing whether the shipment is offered for import. If they will not answer in writing, collect the fields as if Prior Notice is required. Do not empty the confirmation box because someone said “it is only passing through.”

Edible is not automatically this FDA box. Some meat, poultry and egg products sit with USDA at the time of import, not with FDA Prior Notice. Do not scrape a “which meats skip FDA” list off the internet and paste it into a quote. The only move on this booking is to send the product name, the process and the port of entry to the buyer or a licensed broker and ask: FDA or USDA. Until that answer is written, do not put “this product needs no Prior Notice” on the PI, and do not write “all edible cargo includes FDA.”

Food-contact materials, empty bottles and packaging with no food in them are often not the same food sentence. If the floor loads bottles and sauce in one container, do not file the whole box as packaging. Where the lines can be split, ask by line. Where they cannot, follow the broker’s written split. Cosmetics, devices and lamps are not this page’s food sentence. When a buyer drops the three letters “FDA” into one RFQ, split the category: food takes Prior Notice; the paper they call a certificate is usually facility registration. Do not zip them into one file.

Before sales answers the first email, do not start with “who is cheaper on Prior Notice.” Ask the US buyer or the named broker for three written sentences: is this booking FDA food; if yes, who submits; if it looks like meat, poultry or egg, is it USDA. Until those three sentences exist, do not type “we will file FDA,” and do not send the floor to open an account no one can explain.

Who may file: anyone with the facts; opening a store does not file

FDA writes the submitter as any person with knowledge of the required information. That person may use another person to transmit. The sentence helps a factory because it does not say “the US importer must click the mouse.” A Hong Kong contract seller, a mainland document clerk, a US buyer or a licensed broker can be the person who files, or the person who transmits, if they hold this booking’s fields.

The same sentence is easy to twist. A forwarder who says “your Hong Kong company knows the most, so you must open PNSI” is not reading a rule that names the Hong Kong seller. A buyer who says “you are duty-paid, so you file” is talking about who stands as Importer of Record and who pays the duty. That is not an automatic Prior Notice submitter. Knowledge means this booking’s goods, conveyance, parties and registration number match the invoice and the booking. It does not mean who opened an Alibaba.com store.

The year fee wired to ALIBABA.COM HONG KONG LIMITED buys a showcase. CBP and FDA cannot see that store. They will not register it as a PNSI user, and they will not mint a confirmation number from a membership receipt. A showcase screenshot, a gold-supplier badge and a trade-assurance limit will not buy this booking’s confirmation. The master login can change the window, change sub-accounts and read RFQs. It will not go into FDA’s electronic path.

Corpable does not file either. An advisor can sit with you on whether the booking looks like food, which field is empty, and how to answer a login request in complete sentences. We do not stand as US agent. We do not guarantee release in Los Angeles or New York. We do not collect the membership fee into our own account. If you need a US agent, that person sits on the facility-registration path — see the FDA certificate note — and is not the Prior Notice confirmation number.

FOB with a buyer-nominated forwarder does not mean this box already has an owner. The nominated forwarder books space and moves the bill of lading. Whether they are the broker, only a messenger, or the party who already filed this booking’s Prior Notice through ACE still needs their written confirmation and the confirmation number sent back. CIF with the seller booking space needs the same two questions: who files this booking, and which portal. Incoterms allocate freight. They do not sign the FDA box.

You may authorise a broker. Do not sign a blank paper. Name this booking or waybill, limit the purpose to this booking’s FDA Prior Notice, write an expiry, and say whether the authority may be passed on. A paper with no booking, no expiry and “all FDA and customs matters” comes back. If the forwarder wants the Alibaba.com master login or a verification code, refuse. Prior Notice is not filed in the store back office. Giving the login only adds another person who can open the store.

Answer the forwarder in complete sentences: “FDA requires Prior Notice, filed electronically, before arrival, for food imported or offered for import into the United States. Any person with the required information may submit, and may use another person to transmit. Please confirm in writing whether this booking is FDA food, who submits, whether the path is ACE or PNSI, and the anticipated arrival. As contract seller we can supply this booking’s seller, consignee, description, piece count, weight, mode, and any facility registration number we hold. We will not provide the Alibaba.com master login. The store year fee buys a showcase. It is not a filing with FDA.”

Do not reply: “here is the master login”; “we have a registration number so Prior Notice is already filed”; “we will pay the official fine, just file a rough description”; “samples do not file.” Those last lines write the person and the goods wrong together. If the forwarder says there is no booking without the login, split the sentences: the booking can continue; this box waits for a named filer and this booking’s fields.

Vessel: 8 hours before arrival; air: 4 hours — the clock faces the port, not sailing

FDA writes the cutoff by mode, counted back from arrival at the port of arrival. It is not counted from sailing at the load port, and it is not counted from the moment cargo is laden on a vessel at a foreign port. Water or vessel: no less than 8 hours before arrival. Air: 4 hours. Land by road: 2 hours. Land by rail: 4 hours. International mail: before the food is sent. If the clock is wrong, early fields can still be treated as late.

The US ocean ISF is due 24 hours before loading at the foreign port. Forwarders often collapse both rules into “the US wants an advance filing.” The clocks are not the same. ISF is a CBP security filing; air and truck do not use that set. Prior Notice is FDA’s pre-arrival notice for food; an air sample can still need it. Do not retitle an ISF acknowledgement and call it a food confirmation number.

You also cannot file too early. Through PNSI, not more than 15 calendar days before anticipated arrival. Through ABI/ACE, not more than 30 calendar days. Filing next month’s container in PNSI on a Monday can be rejected. If the vessel or flight is not yet named, collect the people and the description first, then file once the anticipated arrival sits inside the window. Do not invent an arrival date just to hold a number.

Do not wait until “8 hours before arrival” to send fields to the broker. Carrier document cutoffs, air close-outs and truck appointments are often earlier. Run documents one cutoff earlier than that: before the carrier cutoff, description, consignee, facility registration number and anticipated arrival should already match. When the floor fills bottles on Thursday, the common name and the net contents should already be with the broker, not rewritten on WeChat the night before arrival as “sauce / gifts.”

Split the clock into four boxes on the inside: the plant’s planned ship date, the carrier’s document cutoff, the estimated departure, and the estimated arrival at the US port. Prior Notice counts back from the last box. The vessel 8 hours is a floor, not a target. The target is a confirmation number back in your mailbox or the broker’s system after the arrival sits inside the window and before the carrier cutoff — not a question at the Los Angeles terminal about “where is the number.”

If the cargo transships and then enters the United States, ask which US arrival FDA faces on this booking. European cargo that changes vessels in Panama for New York faces the New York arrival, not the European sailing. Do not say “Europe already filed a manifest.” Air cargo that changes flights in Anchorage for Chicago needs a written answer from the carrier and the broker: which port of arrival, and which moment starts the 4 hours. Without that written answer, do not promise Friday delivery.

If a sample moves from air to ocean, or bulk moves from ocean to air, recalculate the clock on the new mode. Air becomes 4 hours; ocean becomes 8 hours. The old confirmation number does not survive a new vessel name. A change of mode, port of arrival or anticipated arrival needs the broker’s written call on whether the old notice is withdrawn and a new one filed. How you choose the path sits on air versus ocean. Once you choose, re-check this clock the same day.

This week: FDA PNSI, or the broker through ACE

FDA requires an electronic filing. A homemade spreadsheet does not count. There are two electronic paths. One is CBP’s Automated Broker Interface / Automated Commercial Environment / International Trade Data System — the trade says ACE. The other is FDA’s Prior Notice System Interface, at access.fda.gov. International mail must use PNSI. Vessel, air, road and rail may use ACE or PNSI.

Ask the broker one sentence this week: are you already filing this booking through ACE. A licensed US broker who is doing the entry often puts Prior Notice on the same electronic path as the entry data. If the seller then files a second notice in PNSI, you can end up with two arrival ports or two descriptions that fight. If the broker writes “we file, and we will send the confirmation number,” the seller’s job this week is to send fields and collect the number. Do not file a parallel notice.

If there is no broker and the food is international mail into the United States, PNSI is mandatory. A Hong Kong seller may file at access.fda.gov if they hold the required information. Account opening and identity checks follow FDA’s current page. Do not buy a middleman’s “FDA rush lane.” The mail cutoff is before the food is sent, not a patch after the parcel leaves. If the parcel is already with the post and there is still no confirmation number, treat the notice as late. Do not tell the group that “it has been mailed, so FDA has been notified.”

A waybill printed DHL, FedEx or UPS is not a reason to call the booking international mail, and not a reason to assume ACE. FDA writes international mail as its own mode, separate from air and land. Which mode this booking is belongs in a written answer from the carrier and the broker. Send the waybill number, the origin, the US gateway and whether the path is postal. Do not write “express always uses PNSI” or “express always uses ACE” into the PI.

On both PNSI and ACE, FDA must receive and confirm. Clicking submit is not a confirmation number. A broker who only says “we submitted” and will not send the number has not finished. The confirmation number must point at this booking: port of arrival, mode, description and consignee matching the invoice. Last week’s Los Angeles vessel confirmation will not sit on this week’s New York air booking.

Do not staple ISF, the export declaration, the manifest and a trade-assurance limit into one “US security pack.” The three filings may share a product name and a weight. One acknowledgement with a new title will not fill the FDA box. ISF has no confirmation-number sentence. Prior Notice has no “ten elements” sentence. Inside the team you can keep one line: an ocean food box may need both; air food usually has no ISF and may still have Prior Notice.

If the forwarder says “open PNSI yourselves, then send us the password so we can edit,” stop. The person with the facts may file, and another person may transmit. That is not a reason to bind the store master login to an FDA password and outsource both. If a broker will transmit, use a booking-level authorisation and a field list. If you file yourselves, keep the confirmation number. Do not drop the password into the forwarder group.

The facility registration number and the Prior Notice confirmation number are not the same box

The most common error in Tuesday’s zip file is treating facility registration as notice to FDA on this booking. Food facility registration puts a plant that makes, packs or holds food for people in the United States onto an official list. A foreign facility must also name a US-resident agent. FDA does not issue a registration certificate. How that box is matched sits on the US buyer wants an FDA certificate. A registration number proves the plant is on the list. It does not prove this shipment was received and confirmed before arrival.

A Prior Notice confirmation number is the number FDA issues after it receives and confirms this booking’s notice. Without confirmation, the agency does not treat Prior Notice as complete. The broker file, the arrival-release email and the buyer’s warehouse appointment want the confirmation number, not the digit on the registration PDF. Both numbers can appear on the same shipment: the registration number is often a field inside the notice; the confirmation number exists only after the notice is accepted. Reverse them and the system rejects. The cargo waits.

A Hong Kong company address cannot be the US agent. Opening Alibaba.com does not mint an agent, a registration number or a confirmation number. DDP or “duty-paid” only says who pays and who stands as IOR. Keep the two contracts on two lines. The importer may also be the person who files Prior Notice. The email still needs three lines: who is IOR, who files Prior Notice, and who receives the confirmation number. A forwarder’s “we handle everything” will not write those three lines.

An expired registration can hold cargo at import. That is the registration path. A live registration still needs this booking filed inside the window and a confirmation number back. The other way around is also true: a confirmation number in hand is not product approval, label review or additive clearance. Do not tell the buyer that a confirmation number means “FDA Approved.” Do not write “FDA certified / Prior Notice exempt / store equals filing” on the showcase.

On the contract and the PI, delete these lines: “seller is responsible for all US FDA and clearance”; “the Hong Kong company is registered with FDA”; “FDA penalties are included in the unit price”; “store verification equals Prior Notice”; “the facility registration number is the confirmation number.” Write instead: if this booking is food imported or offered for import as FDA uses that sentence, Prior Notice is filed electronically under 21 CFR Part 1 Subpart I by a person with the required information or by the person they name to transmit; the seller supplies this booking’s description, transport and any registration number on hand; confirmation is the confirmation number FDA returns; handling follows FDA and CBP current practice; the unit price does not lock a chat figure.

Already at the port and the confirmation box is empty: what sales and the floor stop

If the cargo is already in Los Angeles, New York or Chicago and the confirmation box is still empty, stop-loss first, explanations later. The same day, list in writing: mode, waybill or booking number, container number, estimated or actual port of arrival, contract seller, US buyer, product name, and any facility registration number you hold. Ask the buyer three sentences: is this booking FDA food; who will file or who already filed; in which acknowledgement is the confirmation number. Fields you can complete go to the named broker or the person with the facts the same day.

Do not do these things: invent a confirmation number; change one digit on last week’s number; send the master login so the forwarder can “patch the file”; stamp FDA cleared / PN confirmed on the carton; split the same sauce into a “bulk” invoice and a “sample” invoice hoping to skip a filing; write a homemade processing time or a homemade US-dollar penalty into the buyer email. FDA may refuse food offered for import without Prior Notice, with untimely Prior Notice, or with inaccurate Prior Notice. CBP handles the cargo at the port under current practice. Hold, re-export or release follows the current FDA and CBP notice. Do not write a dollar figure from a chat screenshot into the PI, and do not let finance accrue an “official FDA penalty.”

If the forwarder says “we will use our number first and change it after release,” treat the notice as unconfirmed. A wrong confirmation number is harder to unwind than an empty box, because a mismatched shipment is already on the message. If they say “the manifest is complete, that is enough,” a manifest does not replace Prior Notice. If they say “ISF is filed, that equals FDA,” those are two clocks and two systems. Sales corrects the buyer in complete sentences, for example: “Our earlier note that the Hong Kong company can file FDA, that a penalty is in the unit price, and that the registration number is the confirmation number, is withdrawn. Prior Notice on this booking must be submitted electronically by a person with the required information, and must return a confirmation number. We are sending this booking’s description, transport and registration number. Please confirm in writing the submitter, the portal and the confirmation number. Please take this letter as controlling.”

What sales stops the same day is the external promise. Stop: Friday into the buyer’s warehouse, already released, FDA complete, official security fee included in the unit price. Do not stop: asking the floor for the stuffed description and net contents, asking the buyer for the consignee’s legal name, asking the broker for this booking’s portal and confirmation number. Do not tick “arrived, ready to pick up” in trade assurance while the confirmation number is not in your hands.

What the floor stops the same day is any move that locks the cargo to a wrong description. Until the confirmation number is written against this booking, do not send unlocked pallets to the terminal or the airport; do not print Prior Notice / FDA PN / cleared on the carton; do not split the same sauce into “bulk” and “sample” invoices hoping to file once — the official sentence looks at food imported or offered for import, not at your internal sample tag.

Finance deletes “official FDA Prior Notice fee” and “FDA official charge” from the unit price the same day. There is no site-wide official price. A broker or forwarder document fee on this booking sits in the freight breakdown. It is not an agency penalty. The outcome follows FDA and CBP current handling.

1. The same day, obtain written confirmation from the buyer or broker: whether this booking is FDA food, who submits, ACE or PNSI, the estimated or actual arrival, and the waybill or booking number on hand.
2. The same day, the floor sends the locked description, piece count, net contents and gross weight. Unlocked pallets do not go to the terminal or the airport.
3. Until the confirmation number is on this booking’s acknowledgement, sales does not tick trade-assurance arrival and does not write a US warehouse appointment date.
4. If mode or port of arrival changes, recalculate the 8 / 4 / 2 hour floors and the 15 / 30 calendar-day windows on the new mode before you change the floor plan. Do not reuse the old confirmation number.
5. Packaging, invoices and the showcase do not say FDA certified, PN exempt, or “opening the store equals filing.” The membership receipt does not go into the broker’s packet.

If the cargo is already in and the description or the port of arrival still does not match, rewrite from the invoice and the actual transport. Do not change the common name of the food so the bill of lading “looks cleaner.” Who stands as importer still follows the IOR note. If an ocean box is also missing ISF, collect the ten elements on the ISF page. Do not retitle one filing to cover the other. If the box or the air shipment is held, separate a missing confirmation number from a missing registration and from the importer’s entry. Do not promise in the same email that you will pay every terminal charge. If you air a replacement sample, re-ask this booking’s clock and portal — see air versus ocean.

A sales week can be booked by day: day one, write down whether it is food, who files, which portal, which arrival; by noon the next day, send description, consignee legal name, facility registration number and mode; on filing day, the broker or the submitter returns the confirmation number — do not change a digit and retry a failed result; before arrival, sales only says “fields have been sent; FDA’s confirmation number controls,” never “already released.” Do not print “Prior Notice certified” on packaging or the showcase.

Corpable can sit with you on whether this booking is FDA food, who may file, where the arrival clock is written, whether this week is PNSI or ACE, and which of the two numbers is still empty. We do not submit to FDA or ACE. We do not stand as US agent. We do not guarantee release. Membership fees still wire straight to ALIBABA.COM HONG KONG LIMITED.

Questions teams actually ask

Related reading

• FDA certificate is usually registration
• US ISF: the clock faces loading
• The forwarder cannot take IOR
• Air samples, ocean bulk
• Contact Corpable · info@aliad.hk

Written by Corpable Marketing Limited for Alibaba.com Hong Kong-channel sellers. Not legal, tax, or audit advice. Platform, customs, bank, and auditor outcomes follow the latest official notices. Membership fees go to ALIBABA.COM HONG KONG LIMITED. Corpable does not collect them.