C14u—Food and Drug Administration Regulated Imports

Subscriber price: $50.00, Non-subscriber price: $74.00
Estimated total study time: 3 hours 52 minutes

This course is for anyone needing a better understanding of the Food and Drug Administration (FDA) import process and information requirements for entry into the United States including information on Prior Notice (PN), Food Facility Registration (FFR), the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP).

FDA-Food and Drug Administration Regulatory Authority

This lesson begins with an introduction to the Food and Drug Administration and the products they regulate. We look at the regulatory authority behind the strict import requirements and then begin to examine some of the programs that help keep America's food supply safe.

(Estimated study time: 1 hour 4 minutes)

Introduction to FDA Regulated Products
FDA Overview
FDA Regulated Products
FDA Regulatory Authority
FDA Foreign Supplier Verification Program (FSVP)
- FSVP Overview
- Authorization and Responsibilities of the FSVP Importer and Qualified Individual
- FSVP Exemptions and Enforcement Discretion
- FSVP Systems Recognition Arrangements with Foreign Regulatory Agencies
- Unique Firm Identifier for FSVP Food Product Entry Lines
- FSVP Inspections
FDA Voluntary Qualified Importer Program
Marking and Labeling Requirements for Food and Drug-Regulated Products

FDA Prior Notice of Food Products

This lesson focuses on the time limits and pre-arrival import requirements for human and animal food and ingredients. We discuss facility registration and additional data requirements for these shipments.

(Estimated study time: 1 hour 38 minutes)

Introduction to FDA Prior Notice
FDA Facility Registration and Advanced Shipment Notice
- FDA Cosmetic Facility Registration
- FDA Food Facility Registration (FFR)
- FDA Bioterrorism Act Prior Notice of Arrival for U.S. Import
Time Limits for Submission of Pre-Arrival FDA Import Information For Food
Food Products and Prior Notice Data Required
Entry Documentation and Information for FDA-regulated Products
FDA Product Code Tutorial for Imported Products
Elements of the Product Code

FDA Import Processing

This lesson explains the import process from beginning to end and the electronic systems FDA uses to review import information. In addition we will touch on the elements that must be transmitted, examination procedures, and steps to rectify FDA Notices of Action.

(Estimated study time: 1 hour 10 minutes)

Introduction to the FDA Import Process
- FDA Electronic Systems and Reporting Requirements
- Example Data that Triggers PGA Flags in ACE
- FDA ACE Tariff Indicators
- FDA Entry Review
- FDA Import Alerts and Import Reports
- FDA Examination or Sampling
- FDA Compliance Review and Notice of FDA Action or Refusal