US FDA Compliance for Imported Finished Food & Beverage  

If you're a New Zealand food manufacturer or exporter, you may have been surprised by the complexities involved when shipping your F&B products to the US.

Here's a quick run-through of the main US FDA-related documentation requirements, all of which play their part in providing real-time compliance information to US regulatory authorities, and demonstrating compliance with US food safety laws.  So what's in it for you, the exporter?    Ensuring your documentation is accurate, consistent and compliant will help build your brand reputation as a trusted and reliable supplier, by reducing delays and rejections at import. 

Food Facility Registration 

New Zealand final processing, packing and holding facilities must be registered with US FDA, and this registration must be renewed every 2 years.   When applying for facility registration, the facility owner or agent must give permission to the US FDA to inspect the facilities under US food safety laws.    

• Each registered food facility must have a unique identification number (US FDA uses the D-U-N-S numbering system).
• The official record of your food facility registration is the printable 'confirmation copy' available from the FDA unified registration and listing system (FURLS).
• FDA does not endorse or require physical certificates of registration. 

Prior Notice of Import

Each consignment of food imported into the US must be accompanied by Prior Notice of Import documents that include the contact details and DUNS number of the US FSVP Importer, as well as the FDA registration number of the New Zealand food facility.

• Each FSVP Importer must have their own unique identification number (DUNS number).
• You must have a US-based FSVP Importer, whose contact details must be provided at the time the food shipment is imported into the US.
• If you do not have a US importer, you may obtain US FSVP Importer services from a company providing this service.  Some e-commerce platforms such as Amazon US do not provide FSVP Importer services.
• You'll need to know the US FDA Food Product Code that applies to your food or beverage. 
• It's really important to have consistent information on your commercial documents (commercial invoice and packing list) and the Prior Notice of Import.   
• You must wait until you have all of the shipment booking details confirmed, to submit Prior Notice of Import. 

Foreign Supplier Verification Program

US food importers must keep records to show that they have carried out the required FSVP verification to confirm that all imported food complies with US FDA food safety requirements.

Retail-packaged food that is within the scope of the Food Safety Systems Recognition Arrangement (FSSRA) between New Zealand's Ministry for Primary Industries (MPI) and US FDA is exempt from some of the FSVP requirements.

• The US FSVP importer must obtain FSVP documentation from the New Zealand supplier before the first food shipment and must continue to monitor compliance thereafter. While FDA do not routinely check FSVP verification documentation at the time of import, it will be audited. 
• The US FSVP importer must maintain FSVP records for two years and can expect to be audited by FDA.  This may involve an on-site inspection or a review of FSVP records, which must be  supplied to FDA upon request.
• FDA has recently made available an online FSVP Importer Portal for FSVP Records Submission - a voluntary but useful repository to help manage FSVP records.

While New Zealand finished food and beverage are covered under the FSSRA, and while this means that US FSVP Importer compliance monitoring will be focused on supplier compliance with New Zealand food safety laws, it is important to understand that food & beverage consumed in the US must also comply with all applicable US food safety and labeling requirements.

US FDA has inspection authority over food imported from any country (including New Zealand) - this means, in theory at least, that the US FDA may visit New Zealand and carry out facility inspections at any registered food facility.  Because New Zealand has formal arrangements in place we could expect that any such inspection visit would likely be coordinated by MPI. 

Importer of Record and US Customs 

• The importer of record (IOR) is responsible for the payment of tariffs, taxes and fees involved in the import clearance.  This includes a customs bond.
• The IOR is not the same thing as the US FSVP Importer, which is a separate requirement based solely on US FDA FSVP requirements (see above). 
• The importer of record is normally the party who has ownership of the goods at the time of import into the US, but an agent can also be used, particularly if you have no US-based importer. If using an agent, you will need to sign a Power of Attorney.
• So potentially, you could have two separate US based agents (persons or businesses) involved in your food shipment - one carrying out IOR services for you, and the other carrying out the required FSVP verification for you.  You might even have another party acting as US Agent for your food facility FDA registration (or you might have one agent acting both as US FSVP Importer and US Agent for food facility registration). 
• Your freight forwarder will likely provide a licensed US Customs Agent or Broker who can complete import entry documentation on your behalf, as this is a requirement.  

For US Customs requirements and queries about tariffs, taxes, fees and bonds, your freight forwarder will be the first port of call.   Sometimes a recommendation about HTSUS codes (for tariff determinations) from a food export specialist can be helpful.    

US F&B Export-Import Compliance Planning Package

Waka Kuaka offers an introductory compliance planning package to assist exporters new to the US market in planning steps and timeframes to support your first export shipment to the US.  The package includes a one-to-one Zoom session, identification of US compliance requirements tailored to your product and business, and development of a timeframe and steps to address these. 

Waka Kuaka also provides full US FDA food import documentation support, training and services, whether you require help for your first export shipment to the US, or ongoing support. We can link you to US-based agents as and when required. We liaise with your freight forwarder to help get the paperwork right, to ensure smooth import entry and help you build your reputation for reliability from the start.