The Opportunity
The United States offers tremendous business opportunities for international food and supplement producers looking to tap into the vast US market. However, navigating the regulatory landscape can be daunting due to stringent food safety laws. The most important amongst these regulations is the Food Safety Modernization Act (FSMA), which sets the standards for food safety compliance in the US food industry.
Understanding FSMA and FDA Requirements
Introduced in 2011, FSMA encompasses various rules aimed at improving food safety. Every link in the supply chain, from farmers to importers, must comply with relevant FSMA mandates. For food businesses, whether inside or outside the US, this means registering with the FDA. For certain non US food facilities exporting to the US this may also require partnering with a US-based agent who handles communication with the FDA on behalf of the non US food manufacturing facility, but this is just the start of the process. Below are six critical points for a successful, and FDA compliant, US import experience.
Six Critical Points for Successful US Imports
1. FDA Registration
Foreign suppliers must register with the FDA, and to do so, they are required to obtain a Unique Facility Identifier (UFI), usually a DUNS number. FDA registration cannot be completed without a DUNS number. Registered food factilities must be aware that the act of being FDA registered means that FDA is being granted permission to conduct inspections and the registered facility, which cannot be refused without risking suspension of the registration.
2. Foreign Supplier Verification Program (FSVP)
The FSVP rule places a legal responsibility on US importers to verify that their foreign suppliers meet US safety standards. Importers must identify hazards, evaluate risks, approve suppliers, and conduct verification activities. Documentation of these processes is critical and must be readily available for FDA review. Where there is no US importer who owns the goods at the point of entry then the foreign exporting facility will be the foerign Importer of Record and will be required to have an Agent for FSVP (more on this later).
3. FDA Labeling Rules
Labels on food products sold in the US must comply with the Nutrition Labeling and Education Act (NLEA). This involves specific requirements about what can be included on labels, such as identity statements, net contents, nutritional information, and allergen declarations. Missteps in labelling can lead to significant compliance issues which can turn out to be very expensive.
4. USDA Import Permits
Certain food items, such as dairy, meat, and plant products, might require import permits from the USDA (the US Department of Agriculture). It is essential to establish whether your products and their ingredients need a USDA Import Permnit in order to avoid complications, including refusals and detentions, at the border.
5. Understanding the Import Process - FDA Prior Notice
A critical aspect of importing into the US involves filing an FDA Prior Notice before shipment arrival. Identifying key parties and ensuring all documentation is correct helps avoid delays and detentions.
If an FSVP Agent is required for your goods then you will also need to notify your FSVP Agent for each shipment to ensure that you are in compliance with the FDA rules.
In addition, you should always define and document your own commerical invoice for each shipment, especially if you need the serfvices of a US FSVP Agent.
6. FSVP Agent
If a foreign supplier retains ownership of the products at the point of entry, a US-based FSVP Agent must be appointed to ensure compliance. The FSVP Agent plays a critical role in managing FDA compliance, communications and facilitating FDA inspections.
The FSVP Agent is subject to inspection by FDA as if they were the US based importer. Many companies are caught out by the need for an FSVP Agent when they first ship products to Amazon FBA, Shipbob or a warehouse. The key point in determining if you require a US based Agent for FSVP is who owns the goods at the point of entry to the US.
If there is no US based importer who has purchased, or agreed in writing to purchase, the goods then an FSVP Agent must be in place through a signed Statement of Consent Agreement.
The FSVP Agent then becomes responsible for FDA FSMA and FSVP compliance and is inspected by FDA. In practice this means that the FSVP Agent will have to compile a documented FSVP for each supplier and food product imported under their Statement of Consent agreement.
Get in Touch
Importing food into the US can be a complex process, but thorough preparation and understanding of FDA and USDA requirements can mitigate risks and ultimately make the difference between a good import experience and a very difficult and stressful one. Primority Ltd offers specialized services to help businesses navigate these regulatory issues, ensuring compliance and facilitating smooth market entry. Contact us for more infomation.
About the Author
James Flynn, founder and CEO of Primority Ltd, brings over 30 years of experience in food safety and regulatory compliance. Through his leadership, Primority Ltd's Global Import Agent division has become a trusted advisor in helping hundreds of brands comply with FDA and USDA regulations.
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