Determine the correct FSVP importer for your Amazon business, build the required supplier-verification program, organize inspection-ready records, and keep the program current as products and suppliers change.
If you import food, beverages, dietary supplements, or animal food for sale through Amazon, FDA's FSVP rule applies based on the food, the importer definition, and any applicable exemption or modified requirement — not simply because the products are sold on Amazon.
The first step is identifying the correct FSVP importer. For FDA purposes, that is generally the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee, the foreign owner or consignee must designate an eligible U.S. agent or representative as the FSVP importer and obtain the required signed statement of consent.
Amazon can impose marketplace-specific product and category requirements in addition to FDA law. For example, Amazon's published dietary-supplement policy uses third-party testing, inspection, and certification requirements for affected supplement products. Meeting an Amazon marketplace requirement does not replace FSVP, and having an FSVP does not automatically satisfy every Amazon product-compliance request.
The exact requirements depend on the imported food, foreign supplier, importer status, and whether an exemption or modified FSVP provision applies.
For foods subject to the standard FSVP provisions, the importer must establish and follow a written program using qualified individuals.
Not every imported food follows the standard FSVP pathway. FDA provides exemptions and modified provisions for specific foods, suppliers, and importer circumstances.
FSVP is built around the FDA-defined importer, supplier risk, verification, and documented records.
We begin with the importer structure and applicability analysis before building supplier-verification records.
Review your U.S. entity, ownership/purchase arrangement, Amazon/FBA structure, foods, foreign suppliers, and customs-entry process.
Determine standard, modified, or exempt FSVP status and collect the food-safety documentation needed from each foreign supplier.
Perform or review applicable hazard analysis, supplier evaluation, approval, verification procedures, corrective-action procedures, and record structure.
Coordinate importer/UFI information with the broker and maintain the FSVP as suppliers, foods, risks, and verification information change.
We focus on the FDA obligations that affect imported food — not marketplace buzzwords or a one-size-fits-all “certificate.”
Review the U.S. ownership/consignee arrangement and identify the party that meets FDA's importer definition.
Determine whether each food falls under standard FSVP, modified requirements, or an applicable exemption.
Collect and evaluate food-safety records from the foreign supplier and identify missing information needed for the program.
Perform or assess the applicable hazard analysis and supplier-performance evaluation consistent with the FSVP pathway.
Document appropriate verification activities based on the food, hazards, supplier performance, and regulatory requirements.
Coordinate the FSVP importer name, electronic mailing address, and recognized UFI with the customs broker or entry filer.
Organize required records and support prompt production when FDA requests FSVP records or conducts an FSVP inspection.
Update the program when suppliers, products, processes, hazards, verification information, or other relevant facts change.
The fulfillment channel does not decide the FDA importer role.
| Amazon Seller / Brand | Amazon FBA | FSVP Importer | |
|---|---|---|---|
| Primary Role | Sells or owns the product/business relationship | Fulfillment/logistics service for inventory placed in Amazon's network | FDA-defined party responsible for applicable FSVP obligations |
| Automatically the FSVP Importer? | No — depends on whether the seller meets FDA's importer definition at entry | No — using FBA does not by itself make Amazon the FSVP importer | Yes, once the party meets the definition in 21 CFR 1.500 for that food/entry |
| FSVP Records | May maintain them if it is the FSVP importer or performs activities for the importer | FBA fulfillment does not replace the importer's FSVP program | Responsible for establishing and following the applicable FSVP and maintaining required records |
| Entry Information | Can provide information to broker if involved in import | Does not replace the required FSVP importer entry data | Name, electronic mailing address, and FDA-recognized UFI must be provided at entry |
Key point: determine the FSVP importer from the ownership/consignee facts at the time of entry — not from where the inventory will be stored after import.
A seller may need to satisfy both, but they come from different authorities.
| FDA FSVP | Amazon Marketplace Requirements | |
|---|---|---|
| Authority | Federal law and FDA regulations, including 21 CFR Part 1, Subpart L | Amazon seller/product/category policies and compliance programs |
| What Triggers It | Importer and food fall within FSVP and no exemption removes the requirement | Amazon determines which seller, listing, product, or category documentation it requires |
| Typical Focus | Foreign supplier food-safety verification and importer records | Listing eligibility, product safety/compliance documentation, testing, certifications, images, or other marketplace evidence depending on category |
| Dietary Supplements | FSVP has special modified provisions depending on the supplement/component and importer circumstances | Amazon's current supplement policy also uses third-party testing, inspection, and certification for affected products |
| Does One Replace the Other? | No | No |
Amazon policies can change. Seller Central / Account Health should be treated as the current source for Amazon-specific document requests, while FDA regulations control FSVP obligations.
One company can sometimes perform more than one role, but the legal responsibilities are different.
| FSVP Importer | Food Facility U.S. Agent | Importer of Record | |
|---|---|---|---|
| Primary Framework | 21 CFR Part 1, Subpart L | Food Facility Registration — 21 CFR Part 1, Subpart H | CBP customs-entry requirements |
| Primary Function | Responsible for applicable foreign-supplier verification requirements | FDA communications link for a foreign food facility's registration | Customs-entry role for imported merchandise |
| Automatically the Same Party? | No | No | No |
| Marketplace / FBA Changes Role? | No — importer definition still controls | No — foreign facility registration rules control | No — customs facts and entry structure control |
“FSVP Agent” is not a separate FDA registration. If there is no U.S. owner or consignee, an eligible U.S. agent or representative can become the FSVP importer under the regulation, subject to the required consent and entry information.
These terms separate the FDA importer role from marketplace, fulfillment, customs, and food-facility roles.
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals — 21 CFR Part 1, Subpart L.
The U.S. owner or consignee at entry, or — if none exists — the eligible U.S. agent or representative of the foreign owner or consignee meeting FDA's definition.
The person in the United States who, at entry, owns the food, has purchased it, or has agreed in writing to purchase it.
A person with the education, training, or experience necessary to perform assigned FSVP activities and who can read and understand the language of the records reviewed.
Generally the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except limited activities.
Evaluation of known or reasonably foreseeable biological, chemical, and physical hazards for a covered food, subject to the applicable FSVP pathway.
Risk-based activities used to provide assurance that a foreign supplier produces food consistent with applicable U.S. food-safety requirements.
A hazard for which there is a reasonable probability that exposure will result in serious adverse health consequences or death. When such a hazard is controlled by the foreign supplier, annual onsite auditing is the default verification activity unless the importer makes and documents an appropriate alternative determination.
FDA requires a recognized Unique Facility Identifier for the FSVP importer at entry; FDA currently recognizes DUNS for this purpose.
A CBP customs-entry role that may or may not be the same entity as the FSVP importer.
The FDA communications contact for a foreign food facility's registration. This is separate from the FSVP importer role.
Amazon's fulfillment service. Using FBA does not itself determine the FDA-defined FSVP importer or replace required importer compliance.
These issues can create FDA compliance problems, entry delays, inspections, or enforcement risk. The consequence depends on the facts of the entry and the violation.
Using FBA does not replace the need to identify the party that actually meets FDA's importer definition.
The same company can hold both roles, but FDA specifically notes that the FSVP importer may differ from the CBP importer of record.
There is no separate FSVP Agent registration category. The legal role is the FSVP importer, with qualified individuals performing program activities.
The entry filing must identify the FSVP importer using the FDA-required information, including an FDA-recognized UFI.
FSVP allows reliance on certain third-party or supplier information, but the importer must review and assess relevant results when relying on them.
FSVP activities must be appropriate to the foods, hazards, suppliers, and verification needs actually involved.
Dietary supplements and components can be subject to special modified FSVP provisions depending on the importer and product circumstances.
Required FSVP records must already exist and be available promptly; an FDA inspection or written records request is not the time to create the program from scratch.
These services directly support imported food compliance and the FSVP workflow. No unrelated drug, device, or cosmetic cross-selling.
Full FSVP program support for covered importers of human and animal food.
Food Facility Registration and U.S. Agent support for covered foreign food facilities.
U.S. Agent representation for foreign food facilities that are required to register.
Preparation and filing of Prior Notice for covered imported food shipments.
Help obtaining or correcting DUNS information used for FDA importer and facility-identification requirements.
Review Nutrition Facts, allergens, ingredients, claims, and other food-label compliance risks.
Ongoing FDA import-entry monitoring, document coordination, and regulatory support for covered shipments.
Explore Food Facility Registration, FSVP, Prior Notice, labeling, FCE/SID, and related food compliance services.
Direct answers about FBA, FSVP importer determination, “FSVP Agent” terminology, DUNS/UFI, supplier verification, dietary supplements, Amazon marketplace requirements, exemptions, records, and FDA inspections.
An Amazon seller needs to address FSVP when it imports a covered food and the seller or another party meets FDA's FSVP importer definition. The platform used to sell the food does not itself create or eliminate the FDA obligation. Applicability also depends on exemptions and modified requirements.
Not merely because you use FBA. FDA determines the FSVP importer from who is the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee, an eligible U.S. agent or representative of the foreign owner or consignee can serve as the FSVP importer when the regulatory conditions are met.
The FSVP importer is generally the U.S. owner or consignee of the food at the time of entry — the person in the United States who owns the food, has purchased it, or has agreed in writing to purchase it. If no U.S. owner or consignee exists, the importer is the U.S. agent or representative of the foreign owner or consignee at entry, as confirmed by the required signed statement of consent.
Not necessarily. FDA expressly notes that entities identified as FSVP importers may not be the same entities that serve as importers of record for CBP purposes.
FSVP Agent is commonly used as a commercial service term, but FDA does not have a separate FSVP Agent registration category. The regulation defines the FSVP importer and requires qualified individuals to perform FSVP activities. When there is no U.S. owner or consignee, a U.S. agent or representative of the foreign owner or consignee can serve as the FSVP importer if the regulatory conditions are met.
Potentially, when the import structure has no U.S. owner or consignee and the regulatory conditions for a U.S. agent or representative of the foreign owner or consignee are satisfied. The arrangement should be evaluated before entry and documented correctly rather than assuming a service provider can simply be named after the fact.
There is no general standalone FDA 'FSVP registration' that creates an FSVP plan. The FSVP importer must provide specified identifying information at entry and must establish, follow, and maintain the applicable FSVP records.
The entry must include the FSVP importer's name, electronic mailing address, and a unique facility identifier recognized as acceptable by FDA. FDA currently recognizes the DUNS number as an acceptable UFI for FSVP.
FDA currently recognizes DUNS as the acceptable UFI used for the FSVP importer entry requirement. The correct DUNS should correspond to the entity and U.S. location serving as the FSVP importer.
A standard FSVP can include hazard analysis, evaluation of food risk and supplier performance, supplier approval, appropriate supplier verification activities, corrective actions, reevaluation, and required records. The exact requirements can differ under modified provisions or exemptions.
The regulation requires an FSVP for each food from each foreign supplier, but records can be organized efficiently and common records may support multiple foods or suppliers when appropriate. A generic document should not ignore meaningful differences in foods, hazards, suppliers, or verification needs.
The importer must reevaluate the risk posed by the food and the foreign supplier's performance at least every three years, or sooner when the importer becomes aware of new information relevant to the food or supplier.
No. FDA's general FSVP reevaluation requirement is at least every three years or sooner when new information triggers reevaluation. Some verification activities can have annual or other frequencies depending on the hazard and verification determination. An annual onsite audit is the default verification activity when a serious adverse health consequences or death hazard is controlled by the foreign supplier, unless an appropriate alternative is determined and documented.
The FSVP regulation requires records to be made available promptly to an authorized FDA representative upon request. If FDA requests records in writing, the importer must send them electronically or through another means that delivers them promptly. The regulation does not create a blanket 24-hour deadline for every FSVP records request.
Records may be maintained in another language, but if FDA requests an English translation, the importer must provide the translation within a reasonable time.
In many situations the FSVP importer can rely on analyses, evaluations, or verification activities performed by other entities, but the importer must review and assess the applicable results when relying on them and remains responsible for its FSVP obligations.
No. Verification must be appropriate to the food, hazard, and supplier. When a hazard requiring a control could cause serious adverse health consequences or death and the foreign supplier controls that hazard, an annual onsite audit is the default verification activity unless the importer makes and documents a determination that another activity or frequency provides adequate assurance.
Dietary supplements are within the FSVP framework, but FDA provides special modified requirements depending on the circumstances. For example, importers of certain dietary supplement components or finished supplements can be subject to provisions that differ from the standard food FSVP requirements.
Yes. Amazon can impose marketplace requirements separate from FDA law. Amazon's published dietary-supplement policy currently uses third-party testing, inspection, and certification verification for affected supplement products. Sellers should check Seller Central and Account Health for the current requirements that apply to their ASINs.
No. Amazon marketplace testing or certification requirements do not replace FDA FSVP when the importer and food are subject to FSVP. Likewise, an FSVP program does not automatically satisfy every Amazon marketplace compliance request.
No. FSVP includes exemptions and modified requirements. Examples include certain juice and seafood covered by HACCP import requirements, qualifying research/evaluation quantities, certain dietary supplement circumstances, very small importer or small-supplier provisions, and other situations identified in 21 CFR Part 1, Subpart L.
Food imported for personal consumption and not intended for sale or distribution can fall outside FSVP under the applicable regulatory provisions. A commercial Amazon inventory shipment should not be treated as personal-use merely because it is a small quantity.
No. FDA has an exemption for small quantities imported for research or evaluation only when the regulatory conditions are met, including that the food is not intended for retail sale and is not sold or distributed to the public. A commercial sample intended for resale does not automatically qualify.
Certain juice and seafood imported from foreign suppliers that comply with the applicable HACCP regulations are exempt from the standard FSVP rule. Their importers have separate HACCP importer verification requirements.
FSVP contains specific exemptions related to certain alcoholic beverages and certain ingredients imported for use in those beverages under stated conditions. The facts should be reviewed rather than assuming every alcoholic product is either fully exempt or fully covered.
FDA can inspect FSVP records and take action when an importer does not comply. FDA may refuse admission of a food if it appears that the importer is not in compliance with the FSVP requirements for that food, and FDA maintains Import Alert 99-41 for certain FSVP noncompliance situations.
FDA can request FSVP records electronically. FDA also uses the FSVP Importer Portal as an optional method for electronic records submission. The importer must be able to produce required records promptly when FDA requests them.
No. FDA does not issue an approval certificate for having an FSVP. A private consultant can prepare documentation or a service confirmation, but it should not be represented as an FDA-issued FSVP certificate or approval.
A straightforward program can often be prepared within about 5–7 business days after complete product and supplier documentation is received. Complex products, multiple suppliers, missing supplier records, testing needs, or unresolved importer questions can extend the timeline.
Pricing is custom because FSVP workload depends on the number of foods and foreign suppliers, importer structure, supplier documentation, verification activities, shipment volume, and whether ongoing management is included.
Yes, provided the importer uses qualified individuals to perform the required FSVP activities and continues to meet the regulation. A consultant can build the program and hand it off, provide periodic support, or manage agreed FSVP activities on an ongoing basis.
A new supplier must be evaluated and approved under the applicable FSVP requirements before relying on that supplier, unless a regulatory exception applies. The required hazard, supplier, and verification documentation should be updated for the new relationship.
The importer should determine the FSVP requirements for that food and foreign supplier, including whether existing analyses or records can appropriately be relied upon. A new SKU name alone does not determine whether the underlying FSVP work is identical.
Yes, one company can potentially perform multiple services when it meets the requirements for each role. The Food Facility U.S. Agent role and the FSVP importer/program responsibilities remain legally distinct and should be documented separately.
Not by itself. A 3PL or warehouse relationship does not override FDA's FSVP importer definition. The ownership or written-purchase arrangement at the time of U.S. entry remains central to determining the U.S. owner or consignee.
Tell us what you import, who owns or purchases the food at U.S. entry, how Amazon/FBA fits into the fulfillment chain, and how many foods and foreign suppliers are involved. We will review the likely FSVP structure and scope.
