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# 🇺🇸 How to Submit an FDA Prior Notice


If you're shipping food products, vitamins/supplements, medicines, or cosmetics to the United States — including coffee, honey, oils, or any other edible or regulated items — the FDA requires a **Prior Notice** to be submitted before your shipment arrives. Without it, your parcel can be held or refused at the US border. 🚫

This guide walks you through the full process using the FDA's Prior Notice System Interface (PNSI).


## 📋 Before You Start
Book your shipment on TUNL first. You'll need your tracking number (AWB) before you can complete the Prior Notice.

Also have the following ready:

* 📁 Register for an FDA account 
* 🔐 Your FDA account login (username + password) and access to your 2FA email
* 📦 Your shipment's tracking number
* 🏠 The recipient's full name and US address (street, city, state, zip)
* 🏭 Your Food Facility Registration (FFR) number (if applicable)
* 🍯 Product details: name, net weight, quantity, and packaging type

---

## Step 1: 🔑 Log In to the FDA
Go to [__www.access.fda.gov__](https://www.access.fda.gov) and log in with your Account ID and password. You'll be sent a verification code to your registered email — enter it to proceed.

| 💡 Tip: Don't click "Send code" more than once, as this can cause issues.

When prompted about passkeys, you can choose either **Continue password** or set up a passkey — both options work fine.

---

## Step 2: 🖥️ Open the Prior Notice System Interface (PNSI)
From the FDA dashboard, scroll to **Other FDA Systems** and click **Prior Notice System Interface (PNSI)**. You should see a green tick next to it confirming your access. ✅

---

## Step 3: ➕ Create a New Prior Notice
1. Click **Create New Prior Notice**
2. Select **Consumption – Express Courier** as the shipment type
3. When asked if you have a customs entry number, select **No, I want the system to generate a number**
4. Click **Save and Continue**

---

## Step 4: ✈️ Carrier & Shipment Details

* Mode of transport: **Express Courier Air**
* IATA carrier code:
    * **FX** for FedEx
    * **5X** for UPS
* Enter your **tracking number** exactly as it appears on your TUNL booking
* 🗺️ **Port of arrival:** Select the US state and closest port based on the recipient's address. If unsure, enter the delivery address into ChatGPT/Google and ask: *"What would the anticipated state and port of arrival be for this address, sent via express air courier via FedEx/UPS?"*
* 📅 **Anticipated arrival date:** Use approximately 3 days after your booking date
* 🕛 **Anticipated time:** Enter 00:00:00

Click **Save and Continue**.

---

## Step 5: 🏢 Submitter Details (Your Business)
1. Select **Creating for myself**
2. Choose **I have the submitter's food facility registration number**
3. Enter your FFR number — your business name and address should auto-fill

|| 💡 Note: Your Food Facility Registration (FFR) number is issued when you register your facility with the FDA. If you don't have one yet, you'll need to complete that registration before proceeding.


4. Confirm your contact name, phone, and email
5. Click **Save and Continue**

|| 💡 If your facility doesn't auto-populate, use the Favorites/Search function and search for your business name, then select the correct entity.

---

## Step 6: 👤 Importer Details (Your US Recipient)
1. Select **I am not the importer**
2. Country: **United States**
3. Identification method: **Name and full address** (individual customers won't have FFR numbers)
4. Enter the recipient's full name, street address, city, state, and zip code
5. Tick **Add to my favourites** to save time on future submissions ⭐
6. Click **Save and Continue**

---

## Step 7: 🍵 Add Your Food Product(s)
On the summary page, click **Add Food Article**.

### New product (first time)
1. Select **Create New Food Article**
2. Enter the product's common name and market name (e.g., "Honey Oak Blend")
3. Click **Product Code Search** and search for your product type (e.g., "coffee", "honey")
4. Select the closest industry, class, and processing category, then click **Select** to populate the FDA product code
5. Click **Save and Continue**
6. Select **Packaged Shipment**, set package count and type (usually **Box**)
7. Enter quantity in kilograms
8. Click **Save and Continue**
9. When asked about refused entry: select **No**

### Manufacturer details
* Select **Yes** for FFR number
* Search your favourites and select your business
* Shipped from country: **South Africa** 🇿🇦
* Select the shipper from the dropdown (usually the same as manufacturer)

### Owner & Consignee
* Owner: select **Importer** (no FFR for individual customers)
* Ultimate consignee: select **Importer**
* Review all fields, then click **Add this article to my prior notice submission** ✅

### Shipping multiple products? 📦📦
Click **Yes** to add another food article and repeat the steps above.

### Repeat product (copy from previous)
If you've submitted a Prior Notice for the same product before:

1. Select **Copy from previous food article**
2. Choose the closest match and click **Copy**
3. Update the quantity and confirm the importer/owner/consignee fields match the **new** recipient (not an old saved contact) ⚠️
4. Complete the remaining steps and add the article

---

## Step 8: 📤 Submit & Save Your PDF

Once all food articles are added, click **Submit to FDA**, then **Generate PDF**.

Save the PDF for your records using a clear naming format, for example: FDA\_Prior\_Notice\_2025\_06\_[TrackingNumber]\_[RecipientName].pdf

---

## Step 9: 🖨️ Attach the PDF to Your Parcel

Print the FDA Prior Notice PDF and attach it to your parcel in a **separate sleeve**, clearly marked so customs officials can access it at the US port of arrival. 📎

---

## ✅ Quick Checklist Before Submitting
Before you click Submit, run through this:

* [ ] Carrier IATA code is correct: **FX** (FedEx) or **5X** (UPS)
* [ ] Tracking number matches your TUNL booking exactly
* [ ] US state and port of arrival are selected
* [ ] Anticipated arrival date is set (\~3 days post booking)
* [ ] Submitter details reflect your business and correct FFR
* [ ] Importer name and address match the recipient on your shipment
* [ ] FDA product code is populated (not blank)
* [ ] Quantity is correct (e.g., 1kg vs 3kg)
* [ ] Packaged shipment, box type, and package count are accurate
* [ ] Manufacturer is selected from favourites with the correct FFR

---

### 👩‍💻 Need help?

 If you have questions about FDA Prior Notice, need help with your submission, or want to follow up on a customs hold, our support team is happy to help 💬

Reach out to our Support Team on[ __WhatsApp__](http://wa.link/gpiyz3) or[ ](https://tunl.to/#crisp-open)[__Email__](mailto:support@tunl.to) 💙

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