FSVP for Distributors & Customers

Looking for some clarification: 

We do not directly import any materials from overseas. We do however purchase foreign raw materials from US distributors. Does the overall responsibility of FSVP fall on the distributor (the importer) or us? 

We are still doing our due diligence with a supplier approval program and qualifying each material manufacturer, analyzing each lot for identity via validated NIR methods and testing for microbial contamination in regards to the FDA's hazard tables. 

Are we required to have a formal FSVP plan, then? We are a small (10 full time) facility manufacturing ingredients for cosmetics, supplements, beverages, and some foods. 

Thanks! 

We do not directly import any materials from overseas. We do however purchase foreign raw materials from US distributors. Does the overall responsibility of FSVP fall on the distributor (the importer) or us? 

It is the US Distributor that has the responsibility- however with that said they in turn must copy you on each one.

We do not directly import any materials from overseas. We do however purchase foreign raw materials from US distributors. Does the overall responsibility of FSVP fall on the distributor (the importer) or us? 

 

It is the US Distributor that has the responsibility- however with that said they in turn must copy you on each one.

 Is there specific documentation that is needed, say a statement, that shows we do not directly important so FSVP does not apply? 

 Is there specific documentation that is needed, say a statement, that shows we do not directly important so FSVP does not apply? 

The FDA overview on FSVP is pretty clear on only applying to importers: https://www.fda.gov/...ans-and-animals

Similarly the Key Requirements document (attached) defines in the scope: For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

See also the attached "Am I subject to FSVP" decision tree.