Do you need to be an FSVP importer when you import food to sell on Shopify?

Who counts as the FSVP importer for food you sell?

The importer is the US owner or consignee of food offered for import. Without one at entry, it is the foreign owner's or consignee's designated US agent or representative, as confirmed in a signed statement of consent.

Unless 21 CFR 1.501 exempts the food or 1.502 specifies otherwise, for each food you import, you must develop, maintain, and follow an FSVP giving adequate assurances about your foreign supplier.

FSVP verifies the foreign supplier; FDA Prior Notice is a separate filing about the shipment.

Is the food you import exempt from FSVP?

Subpart L covers all imported food and its importers, except as 21 CFR 1.501 specifies; among its exemptions:

• Juice, fish, and fishery products from a supplier that must and does comply with part 120 or 123
• Research or evaluation food meeting four conditions
• Small, non-commercial quantities for personal consumption
• Alcoholic beverages from facilities meeting Treasury and section 415 registration conditions
• Meat, poultry and egg products under USDA requirements at importation

Stock you sell fits neither the research nor the personal-consumption exemption: both require food not intended for retail sale.

Other exemptions include food transshipped through the US, or imported for processing and future export, and not sold or distributed to the public in the US.

A very small importer may follow modified requirements but must still meet §§1.502, 1.503 and 1.509. For human food, that is an importer (including any subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in human food sales plus the US market value of human food imported, manufactured, processed, packed, or held without sale.

What happens at entry, and if you skip FSVP?

Your name, email address and a unique facility identifier recognized as acceptable by FDA must be provided electronically for each line entry filed with Customs and Border Protection.

Food is subject to refusal of admission if it appears its importer fails to comply, and importing it without a compliant FSVP is prohibited under FD&C Act section 301(zz).