Importing Japanese Food to the U.S. : FDA, FSVP & Labeling

Table of Contents

1. Scope of This Guide
2. Do Not Mistake FDA Import Requirements for a Product Approval System
3. What U.S. Importers Should Review Under FSVP
4. Key Considerations When Adapting Japanese Labels for the U.S. Market
5. Additional Considerations by Product Category
6. Documents to Collect from Suppliers
7. Pre-Order Checklist

1. Scope of This Guide

This guide is intended for businesses planning to import Japanese processed foods, seasonings, confectionery, tea, beverages, shelf-stable foods, and refrigerated or frozen products into the United States for resale or commercial use.

The intended audience includes:

• U.S. food importers
• Food wholesalers and distributors
• Retail buyers
• E-commerce businesses
• Foodservice companies
• Food manufacturers
• Brand owners

This article does not constitute legal advice. Instead, it provides an overview of the practical issues businesses should organize and review before entering supplier negotiations or placing an initial order.

One common misunderstanding when importing Japanese food is the assumption that a product is safe to import once it has received advance approval from the U.S. Food and Drug Administration, or FDA.

For most conventional foods, however, the FDA does not operate a system under which each individual product is approved before importation. Instead, the importer and supplier must be prepared to meet the applicable requirements relating to facility registration, Prior Notice, labeling, food safety, the Foreign Supplier Verification Program, and any product-category-specific regulations.

In practice, the priority is not to obtain a single “FDA approval certificate,” but to prepare sufficient documentation to clearly explain the product, its ingredients, how it is manufactured, and who is responsible for compliance.

2. Do Not Mistake FDA Import Requirements for a Product Approval System

According to FDA guidance, imported foods must comply with the applicable requirements for food intended for human consumption in the United States.

Depending on the product, these requirements may include:

• Registration of the foreign manufacturing facility
• Submission of Prior Notice before importation
• Accurate import-entry information
• Compliant U.S. labeling
• Additional requirements for specific categories, such as low-acid canned foods, acidified foods, juice, and seafood

When an imported shipment does not meet the applicable requirements, it may be detained at the port of entry. The importer may then be required to submit additional information, correct the labeling, re-export the shipment, or arrange for destruction or other corrective action.

Simply asking a Japanese supplier, “Can you export this product to the United States?” is therefore not enough.

Before placing an order, the parties should determine:

• Which legal entity will act as the importer
• Who will serve as the FSVP importer
• Who will manage FDA facility information and registration details
• Who will provide and submit the information required for Prior Notice
• Who will be responsible for the accuracy and compliance of the U.S. label

When the supply chain involves a Japanese manufacturer, an export trading company, a U.S. importer, a third-party logistics provider, and the final customer, responsibilities can easily become unclear.

The roles of each party should therefore be documented before the first commercial shipment.

3. What U.S. Importers Should Review Under FSVP

FSVP stands for the Foreign Supplier Verification Program. It is a regulatory framework under which U.S. importers are generally required to evaluate and verify their foreign food suppliers.

Depending on the product and applicable rules, the importer may need to consider:

• Food-safety hazards associated with the product
• The supplier’s compliance history and performance
• The manufacturing process
• Hazard-control measures
• Appropriate supplier-verification activities
• Recordkeeping requirements

Not every food requires the same type or level of verification. The appropriate review will depend on the product’s characteristics, manufacturing process, intended use, and food-safety risks.

For Japanese foods, the relevant considerations may differ significantly between categories such as:

• Fermented foods
• Powdered products
• Dried foods
• Seaweed
• Processed seafood
• Frozen prepared foods
• Seasonings and sauces
• Confectionery

For example, seafood and juice products may be subject to HACCP-related requirements. Products containing meat, poultry, or certain egg products may fall under the jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service, or USDA FSIS, rather than being regulated solely by the FDA.

Alcoholic beverages may also involve requirements administered by the Alcohol and Tobacco Tax and Trade Bureau, or TTB.

The fact that a product is widely sold and commonly consumed in Japan does not, by itself, establish that it meets U.S. import requirements. Importers must be able to classify the product correctly within the U.S. regulatory framework and identify the applicable authorities and requirements.

4. Key Considerations When Adapting Japanese Labels for the U.S. Market

When preparing a product label for the U.S. market, businesses should review items such as:

• Product name or statement of identity
• Ingredient list
• Subingredients in compound ingredients
• Allergen declarations
• Net quantity of contents
• Name and address of the responsible company
• Country-of-origin marking
• Nutrition Facts
• Storage instructions
• Preparation or usage instructions
• Marketing claims
• Certification statements and logos
• Health- or wellness-related claims

A direct translation of the Japanese label is often insufficient.

Differences may arise in areas such as:

• The required order of ingredients
• The naming of food additives
• Allergen terminology
• Nutrition-labeling units
• Serving-size requirements
• Net-quantity formatting
• English-language legibility and placement

Allergen declarations and marketing claims require particular attention.

An expression that is commonly used in Japan may require substantiation, specific formatting, or additional review in the United States. In some cases, it may also create a misleading impression if translated too literally.

Claims and descriptions that may require careful review include:

• Gluten-free
• Organic
• Non-GMO
• Vegan
• Natural
• No additives
• Healthy
• Functional
• Immune support

The appropriate use of these terms may depend on the product, its ingredients, the evidence supporting the claim, and the sales channel.

When using a certification logo, businesses should confirm:

• The exact scope of the certification
• The organization that issued it
• Whether the certification applies to the specific product and facility
• Whether and how the mark may be used in the United States

5. Additional Considerations by Product Category

Shelf-Stable Confectionery and Snacks

For shelf-stable confectionery and snack products, buyers should review:

• Shelf life
• Oxidation of oils and fats
• Product breakage rates
• Units per case
• Application of English-language labels
• UPC requirements
• Target retail price
• Allergen information

Seasonings and Sauces

For seasonings and sauces, important considerations may include:

• Sodium content
• Alcohol content
• Fermentation-derived ingredients
• Storage requirements after opening
• Foodservice packaging
• Compound and multi-component ingredients

Powdered Foods

For powdered products, buyers should evaluate:

• Microbiological specifications
• Heavy metal testing
• Pesticide-related documentation
• Moisture sensitivity
• Clumping
• Variations between production lots

Frozen Foods

For frozen foods, key issues include:

• Required storage temperature
• Product quality after thawing
• Cold-chain management
• Case weight
• Remaining shelf life upon arrival

Seafood, Seaweed, and Seafood-Flavored Products

For seafood, seaweed, and seafood-flavored products, buyers may need to review:

• Seafood HACCP requirements
• Country or region of origin
• Processing methods
• Heavy metal testing
• Iodine content
• Allergen declarations
• Traceability systems

Products Containing Meat or Meat Extracts

For products containing meat, poultry, or animal-derived extracts, the ingredients should be reviewed in detail.

Even a seasoning, soup base, curry, snack, or prepared food may contain meat-derived ingredients. Depending on the formulation, it may be necessary to confirm:

• Whether USDA FSIS requirements apply
• Whether the product is eligible for import
• Whether the manufacturing facility must meet additional requirements
• Whether the relevant animal-derived ingredient is permitted

Alcoholic Beverages

Alcoholic beverages may involve requirements relating to:

• TTB regulation
• State-level distribution rules
• Certificate of Label Approval, or COLA
• Alcohol by volume, or ABV
• Government warning statements
• Importer identification on the label

6. Documents to Collect from Suppliers

Before placing an order, importers and buyers should collect as much of the following information as is relevant to the product:

• Product specification sheet
• Complete ingredient statement
• Overview of the manufacturing process
• Allergen statement
• Nutrition data
• Documentation supporting the stated shelf life
• Recommended storage conditions
• Explanation of lot-code formats
• Certificate of Analysis, or COA
• Microbiological, chemical, or other test results
• Certification documents
• Packaging-material information
• Outer-case dimensions
• Case weight
• Pallet specifications
• Proposed HS code
• Country-of-origin information
• Manufacturing-facility information
• Export history
• Complaint-handling and corrective-action policy

Suppliers may not be able to provide every document immediately. However, identifying which documents are available and which are still missing can significantly reduce procurement and import risk.

Importers should not assume that basic nutritional data per 100 grams will always be sufficient to create a U.S. Nutrition Facts label.

Additional information may be required regarding:

• Serving size
• Prepared or cooked weight
• Edible portion
• Sodium calculations
• Added sugars and total sugars
• Dietary fiber
• Food additives
• Nutrient values per serving

When using an adhesive English label over existing Japanese packaging, businesses should also confirm:

• Whether there is sufficient space for the label
• Whether the English label conflicts with the original Japanese information
• Whether the label remains legible
• Whether it covers the lot code or expiration date
• Whether all mandatory information appears in the appropriate location

7. Pre-Order Checklist

Before placing the first order, confirm the following:

• Which authority has jurisdiction over the product: FDA, TTB, USDA FSIS, or another agency?
• Who will act as the importer, FSVP importer, seller, and party responsible for the label?
• Can the supplier provide the information required for FDA facility-registration checks and Prior Notice?
• Are the product specifications, ingredient information, allergen statements, nutrition data, and shelf-life documentation available?
• Has the English-language label been prepared in accordance with applicable U.S. requirements?
• Are all certifications and marketing claims adequately supported?
• Does the import schedule allow sufficient time for possible inspections, detention, requests for additional documentation, or label corrections?
• Has the buyer calculated the total cost, including labeling, warehousing, disposal risk, and reworking costs, rather than focusing only on the product price?

Preparing for a Successful U.S. Import Program

Importing Japanese food into the United States requires more than identifying an attractive product.

Buyers must evaluate supplier documentation, labeling, importer responsibilities, sales channels, regulatory classification, and logistics as part of a single import strategy.

For businesses seeking to compare Japanese food categories, export-ready suppliers, and potential products for the U.S. market, consulting Umamill can be a practical next step.

Umamill connects international buyers with food manufacturers in Japan, helping businesses explore suppliers and products that align with their commercial, operational, and market requirements.

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Source Notes and Reference

FDA Importing Human Foods; FDA Food Labeling Guide; FDA FSVP rule.