To learn more about foreign supplier verification and imported foods, see our guide

Importers of seafood products must verify that the foreign supplier is compliant with FDA regulations -- even though the food is processed outside the US.

There are two ways to verify a supplier of imported fish / fishery (a.k.a. seafood) products from another country:

1. The importer obtains the product from a country that has an active memorandum of understanding (MOU) with the FDA that documents the equivalency of their food safety systems, or

2. The importer implements verification procedures for ensuring the fishery products being importer were processed in accordance with FDA seafood requirements.

Memorandum of Understanding:

An importer can check if there is a MOU with the exporting country looking it up on the FDA website, here. Note that MOUs are not particularly common.

Verification Requirements for Importing Fish / Fishery Products

If you are unable to obtain the fish / fishery products from a country that has an active MOU, then you must conduct your own verification to confirm that the product was produced in compliance with FDA regulations. This verification may be completed by a competent 3rd party.

The importer's verification process must be written and must include the following, at minimum:

• Product specs for each imported product that ensure that product is not adulterated.

• One or more of the following:

  • HACCP and sanitation monitoring records that relate to the specific lot of fish being imported.

  • A lot-by-lot or continuing certificate from a government authority or 3rd party certifying that the food was processed in accordance with FDA regulation on fish / fishery products (21 CFR §123)

  • Regularly inspecting the foreign processor's facilities to ensure that the imported product is being processed according to FDA regulation.

  • Maintaining on file a copy of the foreign processors HACCP plan and a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Periodically testing the imported products and maintaining on file a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Another equivalent method of verification.

All verification records must be kept on file by the importer.

What’s next:

Guide to Developing a Foreign Supplier Verification Program (FSVP)

More About Supply Chain

Contents

Introduction
Animal Foods
Infant Formula
Bottled Water
Dietary Supplements
Fish & Fishery Products
Juice

Introduction

If you are producing human food then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117. 

However, some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn more their special requirements:

• Animal Food (Includes pet treats)

• Infant Formula

• Bottled Water

• Dietary Supplements

• Fish / Fishery Products (Seafood)

• Juice

If you don't produce any of these specially regulated products, then you are likely regulated under Part 117

Animal Food

If you make animal food (including pet treats), then you will be governed under Title 21 -- Chapter 1 -- Subchapter E.

Unfortunately, this resource doesn't have any detailed information for you, but you can access the regulations at the link above.

Infant Formula

Infant Formula is defined in the FDA regulation as

If your business produces infant formula, you will be required to comply with:

• Part 107 -- Infant Formula

• Part 106 -- Additional Infant Formula Requirements

Bottled Water

Bottled water is defined as:

This includes water labeled as "Drinking water", "Mineral water", "Spring water", "Purified water".

To be clear, water is the only ingredient bottled water.

Water with added carbonation (i.e. soda water, tonic water, and seltzer) is generally regulated by the FDA as soft drinks.

If you are still unclear about what is bottled water, read the definition in the FDA Regulation

Bottled Water producers are subject to the following regulations:

• Part 129 - Processing and Bottling of Bottled Drinking Water

Dietary Supplements

This term is legally complicated and only a partial definition is offered below. Click through the image to access the full definition from the FD&C Act

The regulation for Dietary Supplements can be found in the FDA Regulations at:

• Part 111 - CGMPs in Manufacturing Packaging, Labeling or Holding Operations for Dietary Supplements

• Part 190 Notification Requirements for Dietary Supplements

Fish & Fishery Products (Seafood)

Fish / Fishery Products are defined in the FDA Regulation as:

The regulation for Fish & Fishery Products can be found in the FDA Regulations at:

• Part 123 -- Fish and Fishery Products

• Part 161 -- Requirements for Specific Fish and Shellfish

Note that the Food Safety and Modernization Act has impacted the regulation of Seafood -- in some ways allowing for exemptions to the above regulations. For more detail, see the following guidance document on Seafood HACCP and the FDA FSMA

Juice

Juice is defined as:

A juice processor is regulated in the FDA Regulations at:

• Part 120 -- HACCP Systems

Unlike many other food types, juice processors must comply with Part 120 even if their product is not entering interstate commerce.

If compliant with Part 120, then Juice processors are exempt from 117 Subpart C (Food Safety Plan) and Subpart G (Supply Chain Program)

For more information on juice processing regulations, check out the Section For Juice Processors on the FDA website or this guidance document, below

What's Next:

Do you produce a different type of product?  Requirements for FDA Food Producers

Not sure if the FDA Regulates your business? Learn about FDA Jurisdiction

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