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US import compliance

Private-label food for US retailers: from specification to first container

A US private-label program has two sets of requirements: the federal rules every imported food must meet, and the retailer's own vendor requirements. Most first-container delays come from treating them as one list. This guide sets them out in the order they are usually resolved.

Last reviewed: November 5, 2026

01

Fix the specification first

Formulation, pack format, case configuration and shelf life drive every later step: the label, the barcode, the analysis plan and the container load. Changing any of them after artwork approval restarts the label review.

Specification items to confirm before artwork
Formulation Ingredients and percentages, including allergen-derived ingredients
Pack and case Unit size in metric and US units, units per case, cases per pallet
Shelf life Date format and the storage conditions it depends on
Process category Whether low-acid or acidified canned food rules apply

02

Federal requirements for the imported food

What must be in place before the first shipment
RequirementWho is responsibleReference
FDA food facility registration of the producing site, renewed every two yearsThe producing site21 CFR Part 1, Subpart H
Foreign Supplier Verification ProgramThe US importer21 CFR Part 1, Subpart L
Prior Notice for each shipmentThe importer or its filer21 CFR Part 1, Subpart I
Process filing for low-acid or acidified canned foodThe producing site21 CFR Parts 108, 113 and 114
Food labelingThe party named on the label21 CFR Part 101

Facility registrations must be renewed between 1 October and 31 December of each even-numbered year. The current window closes on December 31, 2026; a registration that is not renewed is considered expired. A registration must include a unique facility identifier; FDA currently accepts the DUNS number.

03

The private-label label

A private-label pack usually carries the retailer's or brand owner's name rather than the producer's. Under 21 CFR 101.5, when the named company did not manufacture the food, the name must be qualified, for example "Distributed by" or "Manufactured for", followed by the company name, city, state and ZIP code.

  • Net quantity in both metric and US customary units
  • The nine major US allergens declared, including sesame
  • Nutrition Facts in the current format
  • Country of origin marked on the consumer package as required by US Customs and Border Protection

The full set of US label elements is covered in Labeling imported food for the United States.

04

Retailer vendor requirements

These come from the retailer's supplier agreement, not from federal law, and vary by retailer. Ask for the vendor manual at the start.

  • GTIN and UPC barcodes, normally under the brand owner's GS1 US company prefix
  • GFSI-benchmarked certification of the producing site, which many US retailers require; see GFSI schemes compared
  • Product liability insurance naming the retailer, at the amount the agreement sets
  • Case and pallet labeling, and any carton marking the distribution center requires

05

The first container

  • Pre-shipment sample approved by the buyer against the agreed specification
  • Lot analysis issued before loading
  • FSVP documentation in the importer's file before arrival
  • Prior Notice confirmation number available to the carrier
  • Container load plan matched to the retailer's pallet and case requirements

06

How we handle it

  • Specification, pack and case configuration fixed before artwork
  • Producing site's FDA registration and, where applicable, process filing confirmed before the order
  • Supplier documentation for the importer's FSVP file assembled before shipment
  • Label reviewed against the US format at proof stage, with the brand owner's name and qualifying phrase agreed

Product programs this guide applies to

Next step

Planning a program that has to meet these requirements?

Send the product, target market, pack format and expected volume. We review the commercial fit and come back with the questions that matter before a quotation.

Source and scope

Source. 21 CFR Part 1 (Subparts H, I and L), Parts 108, 113 and 114, and Part 101, in particular 101.5; US Customs and Border Protection country of origin marking rules. FDA: biennial registration renewal. 21 CFR 101.5: name and place of business. Retailer requirements are contractual and differ by retailer.

Scope. General information for commercial buyers, not legal advice. Federal requirements change, and retailer requirements are set by each retailer's supplier agreement; confirm both for your program.

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Inquiries: sales@alphatradecorp.com

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