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1. What is Prior Notice?

Prior Notice is the process of registering advance information about food, beverages, and dietary supplements imported into the United States. It includes information about the sender and recipient, product description and quantity, country of origin, intended use, and expected port of arrival. Prior Notice provides the US Food and Drug Administration (FDA) with important information about food shipments to the US, helping the FDA ensure food safety for humans and animals.

The FDA requires Prior Notice for all food, beverage, and dietary supplement shipments imported into the US. Prior Notice provides the FDA with important information about food shipments to the US, helping the FDA ensure food safety for humans and animals.

When exporting goods to the US, businesses need to register and declare Prior Notice to the FDA at least 15 days before the goods arrive in the US.

2. Popular Prior Notice forms

Here are some popular Prior Notice forms:

2.1. Prior Notice of Food Importation (PNFI)

This is the most commonly used Prior Notice form for exporting food to the US. PNFI is a form that the importer must complete and send to the FDA, providing information about the origin, type of food, import scale, import location, supplier, and other information about the goods. Below are the details of the PNFI form:

Information about the importer: Includes the name, address, and phone number of the importer.

Information about the supplier: Includes the name, address, and phone number of the supplier of the goods.

Information about the origin: Includes the name and address of the manufacturer or place of origin of the goods.

Information about the goods: Provides a detailed description of the imported food, quantity, unit of measurement, batch number, and production date of the goods.

Information about transportation: Includes information about the transportation vehicle, the name of the transportation company, and the expected port of import.

Information about the import location: Includes information about the port of import and the name and address of the warehouse used to store the goods.

Contact information: Includes the name, address, and phone number of the contact person in case the FDA needs to contact them for more information.

2.2. Prior Notice of Imported Food (FDA 3540-1)

This is a general Prior Notice form used for food, agricultural and animal products. Prior Notice of Imported Food is a form that importers must complete and send to the FDA before the goods are imported into the US.

This form provides the FDA with information on the origin, type of food, import scale, import location, supplier and many other details. The details of the form will include the following information:

Importer information: Including name, address, and phone number.

Information about the manufacturer or place of origin: Including name and address of the manufacturer or place of origin of the goods.

Information about the goods: Including a detailed description of the type of goods, quantity, unit of measurement, batch number, and production date of the goods.

Information about transportation: Including information about the transportation vehicle, shipping company name, and expected date of arrival at the port of entry.

2.3. FDA Prior Notice of Imported Medical Devices

This is a notification form before exporting medical devices to the United States. This is a mandatory requirement of the US Food and Drug Administration (FDA) to ensure the safety and effectiveness of imported medical devices. This notification form includes the following information:

Importer information: This is information about the person or organization importing medical devices into the US, including name, address, phone number, and email address.

Product information: Including product name, product code, quantity, and a detailed description of the product.

Manufacturer information: Including the name, address, and other contact information of the manufacturer.

Information about the intended use: Including information about the intended use of the product, including age and gender.

Information about the final destination of the product: Including the name of the port of arrival, the name of the carrier, and the expected date the product will arrive.

Information about the certification body: Including the name and address of the certification body if the product has been previously certified.

Information about other regulations: Including information about other regulations related to the product, including toxicity and safety regulations.

2.4. FDA Prior Notice of Imported Animal Feed and Ingredients:

This is a form of notification before importing animal feed and ingredients into the United States. This is a mandatory requirement of the US Food and Drug Administration (FDA) to ensure the safety and quality of food for animals produced and used in the United States.

This notification form includes the following information:

Information about the importer: This is information about the person or organization importing animal feed and ingredients into the United States, including name, address, phone number, and email address.

Information about the product: This includes the name of the product, lot number, product registration number (if any), quantity, and detailed description of the product.

Information about the intended use: This includes information about the species of animal for which the product is intended, including age and gender.

Information about the final destination of the product: This includes the name of the port of arrival, name of the carrier, and expected arrival date of the product.

Information about the certifying entity: This includes the name and address of the certifying entity if the product has been certified previously.

Information about the components: This includes information about the components of the product, including their origin and level of processing.

Information about other regulations: This includes information about other regulations related to the product, including regulations related to toxicity and safety of the product.

2.5. FDA Prior Notice of Imported Food Contact Substances

This is a form of prior notice required by the FDA for the importation of food preservatives into the United States. This is a mandatory requirement to ensure the safety and quality of food produced and used in the United States.

The prior notice form includes the following information:

Information about the importer: This is information about the person or organization importing the food preservatives into the United States, including name, address, phone number, and email address.

Information about the product: This includes the name of the product, lot number, product registration number (if applicable), quantity, and a detailed description of the product.

Information about the final destination of the product: This includes the name of the destination port, name of the carrier, and the expected date of arrival of the product.

Information about the ingredients: This includes information about the ingredients of the product, including their source and level of processing.

Information about other regulations: This includes information about other regulations related to the product, including regulations regarding toxicity and safety.

Information about the origin: This includes information about where the product was manufactured, including the name and address of the manufacturer.

Information about the certifying body: This includes the name and address of the certifying body if the product has been certified before.

2.6. FDA Prior Notice of Imported Agricultural Products

Is a prior notice form for importing agricultural products into the United States. This is a mandatory requirement of the U.S. Food and Drug Administration (FDA) to ensure the safety and quality of imported agricultural products.

This prior notice form includes the following information:

Information about the sender: This includes information about the individual or organization sending the agricultural product to the United States, including name, address, telephone number, and email address.

Information about the final destination of the product: This includes the name of the port of destination, the name of the carrier, and the expected date of arrival of the product.

Information about the components: This includes information about the components of the product, including the origin and processing level of these components.

Information about other regulations: This includes information about other regulations related to the product, including toxicity and safety regulations.

Information about the origin: This includes information about the place of production of the product, including the name and address of the manufacturer.

Information about certification units: This includes the name and address of the certification unit if the product was previously certified.

3. FDA Requirements for Prior Notice

The FDA requires a lot of information to be included with each Prior Notice registration. Your registration should include the following information:

Information about the manufacturer, sender, transmitter, carrier, and importer, owner, or ultimate consignee.

Identification of each product in the shipment, which can be completed by providing some of the following information: FDA product code, common product name, estimated quantity, and weight of the product.

Carrier and transportation information, including the estimated time of arrival (port arrival time) - this time should apply to vessel berthing time, aircraft landing time, or estimated border crossing time for road transport.

If you apply the name of any country where the product is refused entry, as required by the Modern Food Safety Act (FSMA).

When submitting Prior Notice through the FDA Prior Notice system interface, you can submit no more than 15 days before the shipment is scheduled to arrive. If you use the Automated Broker Interface/Automated Commercial System (ABI/ACS) interface, you can submit no more than 30 days before the shipment is scheduled to arrive. You can also submit Prior Notice through Registrar Corp's Prior Notice Express, which allows you to store information online, save submission time, and reduce errors in the submission process.

Anyone with knowledge of the shipment can submit Prior Notice, including the sender, importer, customs broker, etc. After receiving Prior Notice, the FDA will issue a confirmation number in barcode form, which must be accompanied by most food shipments.

Prior Notice is also required for commercial exhibition samples and live animals that may be consumed later.

4. Conclusion

This article has summarized the knowledge about Prior Notice for you when exporting products to the United States. If you want to export to a country that is extremely strict about food safety, you need to pay attention to Prior Notice. Because this is the document that determines whether your goods can be exported to the United States or not.

To support Vietnamese businesses in exporting their products to the U.S. market, GOL provides services related to FDA:

FDA registration services for food, cosmetics, and medical devices.

Consulting services on packaging and labeling according to FDA standards.

Training services, application of FSMA standards to factories (for food).

Pre-inspection services, FDA inspection support.

U.S. representative services for exporters and importers.

FSMA compliance services for importers/exporters.

For more information or further advice on FDA certification procedures as well as other logistics services, please contact our hotline: 0909898588 for support!