Frequently Asked Questions

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Which controls must importers verify?
In short, importers must verify that their suppliers comply with the following requirements to the extent they are applicable:

  • Hazard Analysis And Risk-Based Preventive Controls (“HARPC”),
  • Standards of Produce Safety,
  • Non-adulteration regulations, guidance and policies, and
  • Major food allergen labeling requirements.

(More details here)

Who is subject to FSVP?
FSVP applies to all importers of food and beverages, except those importing food that is under the exclusive jurisdiction of the U.S. Department of Agriculture (USDA), and except importers of food subject to a statutory exemption. FSVP defines a food or beverage “importer” as:
 (A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or 
(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

What food is subject to FSVP?
FSVP applies to all imported food, beverages, and dietary supplements unless the importer or foreign supplier is exempted by FSMA, and except foods under the exclusive jurisdiction of USDA.

Are any companies exempt from FSVP?
The FSVP provision does not apply to an importer that is in compliance with FDA’s seafood, juice, or low-acid canned food products requirements. These exemptions are limited to the food safety hazards covered by each respective program. For instance, the exemption applies to importers of low-acid or acidified canned foods, but only with respect to microbiological hazards intended to be controlled by those canned food programs.

Is there a “small quantities” exemption?
FSVP exempts food imported in small quantities if the food is intended for either research purposes or for personal consumption, provided the food is not intended for retail sale and not sold or distributed to the public.

Where can I find out more About the Hazard Analysis And Risk-Based Preventive Controls (“HARPC”) requirements?
FDAImports.com has developed a complete HARPC website that contains not only information on HARPC, but details about our regulatory solutions to help importers and producers comply with every aspect of HARPC (and therefore FSVP). The two provisions are fully integrated at the border and both must be in view when developing a food safety compliance program.