Who needs an FSVP Agent?

Foreign suppliers exporting dietary supplements to the U.S. must designate a U.S.-based FSVP Agent to handle FDA compliance and regulatory communications.

What does an FSVP Agent do?

An FSVP Agent is responsible for: • Verifying supplier compliance with U.S. food safety standards • Maintaining FDA-required documentation • Responding to FDA inspections and audits • Overseeing corrective actions if compliance issues arise

What happens if I don’t have an FSVP Agent?

Failure to appoint an FSVP Agent can result in: • Import detentions and product holds at U.S. entry points • FDA warning letters and monetary penalties • Loss of import privileges and supply chain disruptions

How does the FSVP Agent ensure supplier compliance?

• By conducting supplier risk assessments • Reviewing manufacturing and testing records • Monitoring GMP compliance under 21 CFR Part 111 • Maintaining audit-ready compliance documentation

Can you act as FSVP Agent for multiple suppliers?

Yes. We provide FSVP Agent services for multiple suppliers and product lines, offering consolidated compliance management tailored to your business needs.

How do I get started with your FSVP Agent services?

Simply contact us to schedule a consultation. We’ll assess your import needs, develop a custom compliance plan, and act as your official FSVP Agent to ensure regulatory success.

Dietary Supplement FSVP Agent Services

Overview

Service overview

We act as your FSVP Agent, verify your foreign suppliers against GMP and FDA requirements, and maintain the records FDA may request.

Product documentation being reviewed for compliance

Why this service matters

The FDA requires dietary supplement importers to verify that foreign suppliers meet US standards.
That includes GMP compliance, freedom from contamination and accurate labelling.
Non-compliance can lead to import holds, warning letters, penalties and loss of import privileges.

Acting as Your Official FSVP Agent

Foreign dietary supplement suppliers need a US-based FSVP Agent, and we act as your designated agent.

Serving as the official US FSVP Agent for foreign dietary supplement suppliers
Managing all FDA communications related to FSVP compliance
Responding to FDA enquiries and audits on your behalf

Export-ready goods prepared inside a warehouse — Dietary Supplements
FSVP Agent Services for Dietary Supplement Importers

Supplier Compliance Verification & Risk Assessments

We carry out risk-based assessments of foreign suppliers against FDA dietary supplement standards, including GMP, ingredient safety and labelling.

Verification of GMP compliance as per 21 CFR Part 111
Review of supplier's product testing records and manufacturing certifications
Documentation audits to ensure adherence to US safety standards

Product Safety & Labelling Compliance Assessments

Checking that imported supplements are safe and properly labelled is a key FSVP requirement, and we review each product.

Ingredient safety reviews for compliance with FDA regulations
Verification of structure-function claims to avoid misbranding violations
Assessment of New Dietary Ingredient (NDI) requirements

FSVP Documentation Management

The FDA requires FSVP documentation for supplements, and we keep your records complete, accurate and available.

Maintenance of FSVP documentation in line with FDA requirements
Audit-ready record management for supplier compliance files
Preparation of compliance reports for FDA audits and inspections

Full FDA Inspection & Audit Support

If the FDA inspects your business for FSVP compliance, we support you before, during and after the inspection.

Pre-inspection audits to identify and correct compliance gaps
On-site or remote audit support during FDA inspections
Response preparation for FDA Form 483 observations

Corrective Action Planning & Resolution

If products are detained or a supplier is found non-compliant, we develop Corrective Action Plans (CAPs) to address the issues.

Root cause analysis for compliance violations
Supplier retraining programmes on FDA compliance requirements
Follow-up audits to confirm successful resolution

Ongoing compliance support

Time-Saving
We manage supplier records and FDA communications, so imports keep moving without extra admin.
Regulatory Assurance
Risk-based verification keeps foreign suppliers aligned with FDA dietary supplement standards.
Peace of Mind
Reduce the risk of detentions, warning letters and loss of import privileges.

What you'll need

Supplement FSVP needs supplier evidence under 21 CFR Part 111.

Supplier GMP evidenceProof of compliance with 21 CFR Part 111.
Testing and certificationsYour supplier's product testing and manufacturing certificates.
Label claimsStructure-function claims to check for misbranding risk.
Existing FSVP filesAny supplier compliance records you already hold.

Free tool

FSVP Agent Services for Dietary Supplement Importers