FSVP Compliance for Dietary Supplement Importers: What You Need to Know

fsvp Dec 17, 2025

Importing dietary supplements into the United States requires strict adherence to FDA regulations designed to protect public health. The Foreign Supplier Verification Programs (FSVP) rule requires importers to verify that the food they import meets U.S. safety standards. For dietary supplement importers, understanding these requirements is critical to maintaining compliance and avoiding costly delays or penalties.

Understanding FSVP and Its Purpose

The FSVP regulation, established under the Food Safety Modernization Act (FSMA), fundamentally shifts responsibility to importers to ensure their foreign suppliers meet U.S. safety standards. The rule requires importers to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

For FSVP purposes, the importer is the U.S. owner or consignee of a food product at the time of import. If there is no U.S. owner or consignee, the importer becomes the U.S. agent or representative of the foreign owner, as confirmed through a signed statement of consent.

Modified FSVP Requirements for Dietary Supplements

Unlike standard food products, dietary supplements have specific modified requirements under FSVP, largely because they're already subject to Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Part 111.

Three Categories of Dietary Supplement Importers

1. Importers Subject to Dietary Supplement CGMP Specifications

Importers who establish and verify compliance with certain specifications concerning dietary supplement components and packaging required under the dietary supplement CGMP regulation will not be required to comply with most of the standard FSVP requirements. These importers must comply with requirements under 21 CFR 111.70(b) or (d) regarding specifications for components and packaging, and verify that these specifications are met according to 21 CFR 111.73 and 111.75.

If you fall into this category, you only need to comply with:

General FSVP provisions (21 CFR 1.503)
Importer identification requirements at entry (21 CFR 1.509)

You are not required to comply with most standard FSVP requirements, including hazard analysis, supplier evaluation and approval, or verification activities.

2. Importers Whose Customers Are Subject to CGMP Requirements

If your customer (rather than you) is responsible for establishing and verifying CGMP specifications, you can also benefit from modified requirements. However, you must obtain written assurance annually from your customer confirming their compliance with the relevant CGMP requirements.

Under this scenario, you must comply with:

General FSVP provisions (21 CFR 1.503)
Importer identification at entry (21 CFR 1.509)
Records requirements (21 CFR 1.510)

3. Other Dietary Supplement Importers

Importers of other dietary supplements would be required to comply with the standard FSVP requirements (except the Hazard Analysis requirement). This includes finished dietary supplement products that don't fall under the first two categories.

These importers must:

Evaluate and approve foreign suppliers based on compliance with dietary supplement CGMP regulations
Conduct supplier verification activities focused on CGMP compliance
Document their FSVP and maintain appropriate records
Identify themselves at entry with required information

Importantly, these importers are exempt from the hazard analysis requirement, but their verification activities must focus specifically on compliance with 21 CFR Part 111 dietary supplement CGMP regulations.

Critical Distinction: Dietary Ingredients vs. Finished Supplements

One critical point many importers miss: many dietary ingredient manufacturers are not subject to FDA's Dietary Supplement CGMPs. If you're importing bulk dietary ingredients (raw materials) from manufacturers who aren't subject to 21 CFR Part 111, you cannot claim the CGMP-based exemption. These imports are subject to standard FSVP requirements including hazard analysis and risk-based preventive controls.

Understanding Dietary Supplement CGMP Requirements

21 CFR Part 111 establishes comprehensive requirements for manufacturing, packaging, labeling, and holding dietary supplements. Key requirements include:

Personnel qualifications and training: Qualified employees must manufacture, package, label, and hold dietary supplements
Physical plant and sanitation: Proper facility maintenance, cleaning, and pest control
Equipment design and maintenance: Equipment must be suitable for intended use and properly maintained
Production and process controls: Systems to ensure quality throughout manufacturing
Quality control operations: Independent quality control unit with authority to approve or reject components and finished products
Specifications: Established requirements for identity, purity, strength, and composition
Testing and examination: Verification that specifications are met for components and finished products

Supplier Verification Activities for Dietary Supplements

When you must conduct verification activities under the modified dietary supplement FSVP requirements, appropriate activities include:

Onsite audits: Conducted by a qualified auditor, considering applicable requirements of 21 CFR Part 111 and reviewing the supplier's food safety plan and its implementation
Sampling and testing: Testing of dietary supplements to verify compliance with specifications
Review of supplier's food safety records: Examining relevant documentation demonstrating CGMP compliance
Other appropriate verification activities: Any scientifically valid method to verify the supplier is producing supplements according to processes and procedures that provide the same level of public health protection as required under Part 111

The frequency of verification activities should be based on your evaluation of the supplier and the risk associated with the dietary supplement being imported.

Entry Filing Requirements

All FSVP importers, including those importing dietary supplements, must provide specific information when filing entry with U.S. Customs and Border Protection:

Importer name
Electronic mail address
Unique facility identifier (UFI) recognized as acceptable by FDA

Beginning July 24, 2022, FSVP importers must provide a DUNS number as the unique facility identifier when filing entry with CBP. The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP purposes.

Common Pitfalls to Avoid

Assuming all dietary supplement imports qualify for modified requirements: Only those complying with specific CGMP provisions qualify for the most streamlined requirements
Overlooking the dietary ingredient vs. finished product distinction: Raw material suppliers may not be subject to dietary supplement CGMPs, requiring full FSVP compliance
Failing to obtain annual written assurance from customers: If relying on your customer's CGMP compliance, you must obtain this documentation yearly
Not maintaining proper documentation: Even with modified requirements, proper records must be kept and made available to FDA upon request
Neglecting to update your FSVP: Importers must reevaluate their programs at least every three years or when new information becomes available about hazards or supplier performance

Taking Action

For importers of dietary supplements, FSVP compliance is not optional—it's a legal requirement that's being actively enforced. Understanding which category of importer you fall into and what specific requirements apply to your situation is the first step toward ensuring compliance.

If you're importing dietary supplement components and can establish and verify compliance with CGMP specifications, you may benefit from significantly streamlined FSVP requirements. However, if you're importing finished products or raw materials from suppliers not subject to dietary supplement CGMPs, you'll need a more comprehensive program in place.

Don't wait for an FDA inspection or import detention to discover gaps in your FSVP. Review your current practices, ensure your foreign suppliers meet applicable standards, and maintain thorough documentation of your verification activities. The investment in compliance today protects your business from costly disruptions tomorrow.