FSVP: The mandatory factor that causes many Vietnamese businesses to be rejected by the FDA

When exporting food to the U.S., misunderstanding or ignoring FSVP — a mandatory FDA requirement — can lead to rejected shipments and serious import delays. Don’t overlook your U.S. representative.

FSVP: The mandatory factor that causes many Vietnamese businesses to be rejected by the FDA
FSVP: The mandatory factor that causes many Vietnamese businesses to be rejected by the FDA

What is FSVP and why should Vietnamese businesses care?

When entering the U.S. market, many Vietnamese exporters encounter a lesser-known but critical term: FSVP, which stands for Foreign Supplier Verification Program. This is a key part of the FDA’s Food Safety Modernization Act (FSMA), designed to ensure that imported food meets the same safety standards as domestic products.

According to U.S. regulations, any food, beverages, dietary supplements, or raw ingredients sourced from outside the U.S. must have a designated U.S.-based party responsible for verifying safety compliance before distribution. Without a valid FSVP representative, your shipment may be rejected at the port — without any further inspection.

What is FSVP and why should Vietnamese businesses care?
What is FSVP and why should Vietnamese businesses care?

The U.S. representative: A mandatory element for FDA acceptance

What many Vietnamese businesses fail to anticipate is that FDA registration must include the details of a valid FSVP agent in the United States. This representative is not just a legal point of contact — they are responsible for verifying production processes, conducting hazard analyses, and ensuring the imported products fully comply with FDA food safety rules.

Your FSVP representative can be a distributor, importer, or an authorized third-party entity based in the U.S. However, not all parties are willing — or qualified — to take on this role. Without a clear agreement from the beginning, many Vietnamese exporters find themselves without anyone to fulfill the FSVP obligation, causing their shipments to be held, delayed, or returned.

The U.S. representative: A mandatory element for FDA acceptance
The U.S. representative: A mandatory element for FDA acceptance

Why do Vietnamese businesses get rejected due to missing FSVP?

Some exporters mistakenly believe that registering an FDA facility ID is enough to access the U.S. market. In reality, the FDA doesn’t approve each individual product before entry. Instead, it relies on a compliance system — and FSVP is a key pillar. If your goods arrive in the U.S. without a named and compliant FSVP agent, your file will be marked as invalid, triggering warnings, strict inspections, or outright denial of entry.

This issue is especially common among small and medium-sized Vietnamese enterprises without a U.S. office or official distribution partner. Many try to handle the process themselves, unaware of the mandatory FSVP requirement — resulting in mistakes from the very beginning.

Why do Vietnamese businesses get rejected due to missing FSVP?
Why do Vietnamese businesses get rejected due to missing FSVP?

How can you comply with FSVP regulations?

A sustainable solution for Vietnamese exporters is to work with a specialized consulting partner who has experience and a trusted network in the U.S. They can help with document preparation, identifying a qualified FSVP representative, and guiding you through the verification process.

It is also essential to establish a clear partnership with the FSVP party to ensure long-term compliance and avoid disruptions in your supply chain.

Furthermore, businesses must develop technical documentation, including food safety plans, risk analysis, and traceability systems according to FSMA standards. This supports the FSVP agent in providing evidence to the FDA. Keep in mind: FSVP rules are continuously updated — staying informed is non-negotiable.

How can you comply with FSVP regulations?
How can you comply with FSVP regulations?

-> Learn more: Mandatory products that must be registered with the U.S. FDA

MettiFDA – Your trusted partner in overcoming the FSVP barrier

At MettiFDA, we understand the challenges Vietnamese exporters face when entering the U.S. market. Our team of FSVP experts and our network of partners across the United States provide complete support — from risk evaluation and technical file preparation to assigning a qualified FSVP agent.

We don’t just help you comply with FDA requirements — we guide you toward sustainable export strategies to ensure smooth customs clearance and a strong presence in the global market.

MettiFDA – Your trusted partner in overcoming the FSVP barrier
MettiFDA – Your trusted partner in overcoming the FSVP barrier

Conclusion

FSVP is no longer an option — it is a mandatory requirement if Vietnamese businesses want to export legally and sustainably to the United States. Understanding the FSVP program and establishing a proper U.S. representative is the key to avoiding costly rejections — and MettiFDA is ready to be your trusted partner on that journey.

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