Key FSMA Principles for Export Businesses
Below are seven core principles that businesses must fully understand when exporting food products to the United States.
Preventive Controls Based on Hazard Analysis (HARPC)
One of the foundational principles of FSMA is that businesses must implement a preventive control system based on hazard analysis, also known as HARPC. This requires companies to conduct a comprehensive assessment of potential risks throughout the entire production process—from raw materials, pre-processing, and processing to packaging and transportation. Hazards may include biological agents such as harmful bacteria, chemical residues, or physical risks like foreign objects. Based on this analysis, companies must develop a suitable preventive control plan to eliminate or minimize food safety risks. This plan must be designed and supervised by a PCQI-certified individual (Preventive Controls Qualified Individual), who has completed advanced training recognized by the FDA.
Facility Registration and U.S. Agent Appointment
All food manufacturing facilities outside of the United States, including those in Vietnam, must be registered with the FDA if they wish to export to the U.S. market. This registration is a mandatory requirement to ensure transparency and strict control within the global food supply chain. Additionally, companies must designate a legal representative in the U.S., known as a U.S. Agent. This person acts as a liaison between the business and the FDA and is responsible for receiving notifications, assisting with inspections, responding to warnings, and coordinating incident responses. Appointing a reliable and knowledgeable U.S. Agent with a strong understanding of U.S. food regulations is essential to ensure smooth and lawful export operations.
Foreign Supplier Verification Program (FSVP)
The Foreign Supplier Verification Program (FSVP) is a mandatory requirement for U.S. importers, but it is also closely related to exporters in Vietnam. The program’s goal is to ensure that imported food products comply fully with FDA food safety standards. This includes evaluating the supplier’s production process, risk assessments, laboratory certifications, and even product labeling. While the importer is responsible for implementing the program, Vietnamese exporters must actively cooperate, provide technical documentation, and ensure that internal production processes meet U.S. standards. In many cases, businesses can authorize a third-party service provider to support the FSVP process and ensure the completeness and validity of documentation.
Traceability and Recordkeeping
Traceability is one of the core FSMA requirements aimed at enhancing transparency and control across the food supply chain. Businesses must establish a two-way traceability system—allowing them to identify which raw materials were used in a specific batch, and also trace finished products back to the raw material suppliers. Furthermore, all records related to production, quality testing, transportation, exportation, and product recall (if applicable) must be maintained systematically and be easily accessible. When requested by the FDA or in case of an incident, the ability to provide accurate and timely records is a decisive factor in avoiding penalties or suspension of export activities.
Inspections and Compliance
The FDA reserves the right to inspect foreign food production facilities at any time, without prior notice. This means that exporters must consistently maintain hygiene conditions, food safety standards, and quality control systems. All documentation related to production, testing, sanitation, and equipment operation must be prepared and ready for inspection. Failure to meet standards during inspection may result in the company being placed on the DWPE list (Detention Without Physical Examination), meaning that its products could be detained at U.S. ports without physical inspection. This can cause serious consequences, directly impacting finances, brand reputation, and relationships with import partners.
Rapid Incident Response and Management
An effective food safety management system must include an emergency response protocol in case of an incident. When there are signs that a product is contaminated, contains foreign objects, is mislabeled, or receives warnings from customers or regulators, businesses must be able to respond quickly and accurately. This includes precisely tracing affected batches, immediately notifying all relevant parties (including the FDA if needed), and executing a product recall effectively. Delays or lack of professionalism in handling such issues can lead to financial loss, loss of consumer trust, and long-term export bans.
Staff Training and Capacity Building
FSMA places a strong emphasis on the human factor in managing food safety. Individuals directly involved in production, quality supervision, and food safety control must be well-trained, fully understand procedures, and stay updated on regulatory changes. Positions such as PCQI, FSVP coordinators, and quality managers must hold valid certifications and demonstrate sufficient expertise. Investing in training not only helps ensure better compliance but also empowers companies to handle incidents effectively and collaborate confidently with international partners.
What Should Businesses Care About?
Critical Success Factors
- Gain a thorough understanding of FSMA regulations that apply to their specific product type
- Register for FCE/SID if their product falls under the low-acid canned food category
- Appoint a reliable U.S. Agent who can work proactively with the FDA
- Train Internal Personnel or Partner With Professional Service Providers Such as Gplus
