Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments | Guideline Explorer

Description

This guidance document is a restatement of the Food and Drug Administration’s (FDA's) current requirements for prior notice of food presented in simplified format and language. As guidance, it is not binding on either FDA or the public. FDA notes, however, that the regulation that is the basis for this pamphlet establishes requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulation at 21 CFR Part 1, Subpart I, in addition to reading this pamphlet.

Scope & Applicability

Product Classes

Placebos

Prior notice requirements depend on testing purpose

U.S. Goods Returned

Food produced in the U.S. and reimported; requires prior notice.

Trade Sample

Food imported for commercial testing or display

casings

Animal-derived containers for sausage under FDA jurisdiction.

household goods

Personal food items included in a move to the U.S.

in-flight food

Food moved to U.S. caterers for export or domestic flights.

Meat food products

Exempt from prior notice if under USDA jurisdiction

Imported Food

Food imported or offered for import into the United States; Articles of food imported or offered for import into the U.S.; Food products brought into the U.S.; food offered for import into the U.S.

Food

articles used for food or drink for man or other animals

Dietary supplements

subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements

Stakeholders

Submitter

The entity providing information for the AFIC process.

Manufacturer

Entity responsible for submitting NDINs

carrier

individual or entity transporting the food

importer

Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for

Consolidator

Firm that consolidates articles of food from different growers; Entity identified if grower identity is unknown

Broker

Entity in the supply chain between the receiving facility and the supplier

charity

Nonprofit organizations importing food.

express carrier

Entities like FedEx transporting food into the U.S.

Customs brokers

Users familiar with FDA Country of Production term

Transmitter

Entity transmitting the prior notice; Person who transmits prior notice information on behalf of a submitter; person or entity submitting the prior notice; Notification of prior notice refusals and holds will be provided to the transmitter.

Regulatory Context

Attributes

estimated quantity

change that does not require resubmission

anticipated arrival information

change that does not require resubmission

Identified Hazards

Hazards

biological contamination

food safety refusal reason

radiological contaminants