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.