Overview: Under provisions of the Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. Importers can import foods into the United States without prior sanction by FDA, as long as the facilities that produce, store or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA. Imported food products are subject to FDA inspection at the time of entry. Both imported and domestically produced foods must meet the same legal requirements. FDA may detain and refuse shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. A good working knowledge of the FDA requirements and how to best meet those requirements is imperative for food importers. This course will outline the major FDA requirements and workable strategies for compliance. Many illuminating case studies, do's and don'ts will be discussed.
What you will learn:
- Overview of the roles and jurisdictions of USDA, FDA and CBP
- The role of the Custom's broker, private lab, consultants and attorneys
- Food establishment registration
- Prior notice of entry filings
- ITACS and PREDICT replace OASIS - Improvements or more headaches for importers?
- Detention without Physical Examination (DWPE)
- FDA inspections and sampling - Routine surveillance and focused special projects
- Demonstrating compliance and overcoming the appearance of a violation
- Petitions for re-labeling and reconditioning (FDA Form 766)
- Refusals - Re-export, destroy or try to rescind?
- Reportable food registry and recalls - What to do when disaster strikes
- HACCP, food safety and defense - Going beyond simple compliance
- Upcoming laws and FDA enforcement strategies - What the future may hold
Aemtek Inc.
